Welcome to Anaheim . . . . . . . . . . . . . . . . . . . . 3 InformexUSA Conference Schedule. . . . . . . . . 4 Networking Connects Community. . . . . . . . . . 4 Showcases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Chemical Educational Foundation Develops Future Workforce. . . . . . . . . . . . 22 Art of the Party: C&EN-sponsored Fete . . . . . 23 SOCMA Trade Association. . . . . . . . . . . . . . . . . 6 International Membership . . . . . . . . . . . . . . . . 6 Mobile Website Increases Access . . . . . . . . . . . 7 Five Minutes With… Dr. Trevor Laird, Organic Process Research & Development. . . . . . . . . . . . . . . 9 Aslam Malik, AFC. . . . . . . . . . . . . . . . . . . . . . . 11 Joseph Chiaroni, Nova Molecular. . . . . . . . . . 17 A packed crowd was on board Tuesday at the InformexUSA welcome reception sponsored by Dixie Chemical Company. Showcases Focus on Company Strengths Within Industry Editor’s Note: This is Part 1 of a 2 part series focusing on Evonik catalyzes growth InformexUSA Showcases on Tuesday which featured indus- With an emphasis on its growth, Evonik’s Tiffany A. try leaders in briefings aimed at highlighting the company Grant focused the company’s showcase on an overview strengths. Part 2 will appear in Thursday’s Show Daily. See Rx-360 page 5 Tony Uberoi, Gabriel Performance Products . 18 Exhibitors News. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8–21 Exhibition Map, List of Exhibitors . . . . . . 12–13 Advertiser Index. . . . . . . . . . . . . . . . . . . . . . . . 23 Rx-360 Members Link with Habitat at Informex W hen members of Rx-360 made plans for Valley Habitat for Humanity—was seven homes for Informex 2013 in Anaheim, they wanted families in need in southern California. They also hoped to to accomplish more than their stated raise more than $10,000 for the organization, which has mission of monitoring global drug quality. Deciding a vision of a world where everyone has a decent place to to repeat a gratifying experience with Habitat for live. When families are selected to get a home through the Humanity in New Orleans at Informex 2012, the group program, each adult in the family volunteers 250 hours to marshaled their forces Tuesday, ignoring warnings of help with its construction. downpours and possible sleet. The target this time—in partnership with Pomona Since its inception in 1976, Habitat for Humanity See Rx-360 page 22 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Welcome to InformEx USA— The Global Chemical Marketplace W e are excited to have you here with us in Anaheim. A full agenda of business building meetings, discovering new solution providers, knowledge exchange, and networking awaits, and we hope that you take advantage of all that InformEx has to offer. For our 29th edition of the event, we are pleased to welcome 53 new exhibitors to the show floor—offering more sources and partners of industry innovations to help grow your business and facilitate your product development plans. Also, for 32 percent of our audience, this is your first time at InformEx, so please take the time to review the show directory so you are familiar with the daily schedules and offerings on the show floor and in the conference. This show daily is a valuable resource as well for staying informed of late breaking announcements, exciting new products and keeping abreast of the sessions and trends that will be topics of discussion over the next few days and in the future. The QR code below will also allow you to access the mobile site Daniel Read of the event. Of special note is the expanded educational component being offered this year, that provides expert insight on the latest developments and technologies impacting a broad spectrum of our industry. There is something for everyone in this program that covers key areas of business: Chemical Trends, Pharmaceutical Manufacturing, Regulatory & Compliance, Specialty Chemicals, as well as several business building and professional development classes. The Welcome Reception last night hosted by Dixie Chemicals kicked off the ample networking opportunities that are InformEx’s signature. Even more networking opportunities are in store for you, including the all-inclusive breakfasts and lunches as well as tomorrow’s cocktail reception. You are invited to partake in the popular Speed Networking sessions today and tomorrow, from 3-4 pm in the Networking Lounge on the show floor. Bring plenty of business cards and look forward to meeting new people from procurement, purchasing, R&D, and other areas of the business. As we begin our 2013 event, it is hard not to share some of our plans for 2014. InformEx will be celebrating its 30th anniversary in Miami, Jan. 22-24, 2014. Miami ranks highly as a desirable and accessible location, and we are confident that this milestone year will be attractive and rewarding for everyone. Please visit the InformEx Booth 1709, to learn more about incentives for booking space and sponsorships for this celebratory 2014 event. We also invite you to stay connected to InformEx throughout the year through our website and active social communities. Yearround it’s a go to source for the latest information and resources for doing business in the ever-changing chemical marketplace. And if you are sharing your InformEx experience through your social media communities, the event hashtag is #inf13. It is our honor to host you here in Anaheim. Again, please be sure to take advantage of all the opportunities we have available for you, and we welcome your insight about your experiences over the next few days. Your honest feedback is important to the improvement and growth of our flagship event. We hope you have productive meetings and a rewarding experience, InformEx USA Mobile Site Daniel Read Portfolio Director UBM Live InformEx & Chemical Group P u b l i s h e d Publisher Kenneth M. Carroll Editor Sharon Donovan Reporter Ilene Schneider Art Director Connie Hameedi Photographers Peter Cutts Advertising Sales USA Dean Baldwin, Robert LaPointe, Thomas Scanlan b y A m e r i c a n Europe Uwe Riemeyer, Paul Barrett, Nadia Liefsoens Asia Minghua Lu, Angel Zu, Mai Hashikura, Shigamaro Yatsui, Faredoon Kuka Production Manager Joseph Davis C h e m i c a l S o c i e t y ACS Publications Advertising Sales Group 480 East Swedesford Road Wayne, PA 19087 Phone 610.964.8061/Fax 610.964.8071 http://cen.acs.org/onsite.html 3 4 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Conference Schedule—Today All sessions at Marriott Anaheim 8 am From Big Pharma to Virtual Biotech: What Do They Really Want in a Vendor?—Orange County 3 Perspectives on the Specialty Chemical Industry—Orange County 1 The One Sales Test You’re Guaranteed to Fail: Tips to Sell Your Company and Regional vs. Global Sourcing: When Does Proximity Matter?—Orange Yourself at a Trade Show—Orange County 2 County 4 Differentiating Yourself From the Competition in the Green Supply Chain— Orange County 3 Noon How Your EHS&S System Affects Your Bottom Line—Orange County 1 9 am Driving Sales Through Research—Orange County 2 The New AIA: Changes to Intellectual Property Rights—Orange County 1 How Does Excipient GMP Certification Protect the Patient?— Orange County 3 Strategic Outsourcing Partnership: Transactional Working Relationships vs. Partnership Alliances—Orange County 2 Novel High Resolution XR-Powder Diffraction Protocol for APIs Polymorph API Sourcing in Emerging Markets—Orange County 3 Contamination—Orange County 4 Part 1: Discovering the Latest Applications of Specialty Chemicals to Drive Technical Innovation—Orange County 4 1 pm High Potency APIs—AFC Has Them ‘Under Control’—Orange County 1 11 am Enabling Green Chemistry and Profitability Through Route Scouting— Orange County 2 Selling Quality Products to Quality Companies, What is Critical to Know— Orange County 1 Trace Impurity Control and Resolution—Orange County 3 An Artisan Approach: One Stop Shop vs. Specialty Companies— Sourcing ADC Development, Manufacturing Services for More Efficient Orange County 2 Supply Chain—Orange County 4 Connecting the Community with Networking, Social Media I S h o w - a t- a - G l a n c e nformEx is renowned for its networking opportunities, and this year’s event W e d n e s d a y , once again delivers attendees a full range of opportunities to help facilitate strategic business relationships, renew old contacts, and mingle amongst peers. Last night’s Welcome Reception, sponsored by Dixie Chemicals, set the relationship-building tone. Attendees and exhibitors had the chance to meet and talk about their expectations for the week ahead and new attendees were introduced to the InformEx experience. Today and tomorrow, attendees can also enjoy catered breakfasts and lunches on the T o d a y 7 am–5:30 pm Registration Open—Lobby C 7:30–10 am Networking Breakfast—Exhibition Floor Hall C & D 8–10 am Morning Conference Sessions—Marriott Anaheim 10–11 am Conference Break/Exhibit Time 9 am–5 pm Exhibits Open—Halls C & D 11am–2 pm Afternoon Conference Sessions—Marriott Anaheim show floor and near the conference sessions. There is also another cocktail reception on 11:30 am–2 pm Networking Lunch—Exhibition Floor Hall C & D Thursday night, sponsored by C&EN, in Lobby D of the convention center. 3–4 pm Informex Speed Networking—Networking Lounge Back by popular demand are the Speed Networking Sessions. Taking place in the T h u r s d a y , Networking Lounge on the show floor from 3–4 pm on Wednesday and Thursday, F e b r u a r y these sessions give attendees the chance to meet people in roles such as buying, 7:30 am–5:30 pm Registration Open—Lobby C sourcing and procurement. In these high energy and fast paced sessions, participants are encouraged 2 1 7:30–10 am Networking Breakfast—Exhibition Floor Hall C & D 8–10 am Morning Conference Sessions—Marriott Anaheim to have a short conversation with one person and then switch every few 10–11am Conference Break/Exhibit Time minutes throughout the hour. These Speed Networking sessions provide a great way 9 am–5 pm Exhibits Open—Halls C & D of being introduced to numerous potential customers and suppliers in a short space 11 am–2 pm Afternoon Conference Sessions—Marriott Anaheim of time, exchanging business cards, and expanding networks and contacts within 11:30 am–2 pm Networking Lunch—Exhibition Floor Hall C & D the industry. When not being used for the Speed Networking Sessions, the Networking 3–4 pm Informex Speed Networking—Networking Lounge 5–6:30 pmInformex Networking Reception—Lobby D— Sponsored by C&EN Lounge is also a great place for buying teams and attendees to re-connect during the event and discuss what they have seen and heard at InformEx. F r i d a y , To keep the conversation going after the event, InformEx also has active social F e b r u a r y 2 2 communities on LinkedIn and Twitter with plenty of discussions and information 8 am–Noon Registration Open—Lobby C sharing year-round. 7:30–10 am Networking Breakfast—Exhibition Floor Hall C & D Go to www.informex.com to learn more and join. If you are tweeting from the event, use #inf13 as your hashtag! 9 am–Noon Exhibits Open—Halls C & D INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California From Showcases page 1 Regis describes long history of Evonik Industries and the catalysts business line. Evonik’s catalysts line Regis Technologies described its customer-centric organization with a highly encompasses a wide range of technologies for various markets, including qualified and experienced technical staff, outstanding project management team life sciences and fine chemicals, industrial and petrochemicals and polyolefins. and the facilities and regulatory experience to ensure success at its showcase In addition to a proprietary product portfolio, Evonik offers business presentation. The presentation described Regis’s broad range of services, vast models to its customers who have toll production requirements or even chemistry experience and high rate of repeat business, as well as its investment in requirements for new catalyst technologies that involve joint development. people, facilities and technologies to better serve the life science community and Evonik Industries, a leading 5 create a better, safer and more specialty chemicals companies, empowering environment for is an expert in power its employees. generation from hard coal and Regis, a custom API renewable energies and one of manufacturer based in the the largest private residential Chicago area, is a family real estate companies in owned business that has met Germany. The company’s the needs of pharmaceutical performance is shaped by and related life science creativity, specialization, industries for more than 50 continuous self-renewal years. Its primary mission and reliability. is to provide development, optimization and cGMP Optima emphasizes fine chemical capabilities manufacturing services to Optima Chemical commercial needs. support customers’ clinical and offers a wide variety of organophosphines, metal Company highlights comprehensive approach hydrides, and grignards within Carbogen Amcis’ Scott A. its well-established boronic Miller, head of special projects acid product lines. These and responsible for the new products are in line with company’s Antibody Drug customer needs and provide Conjugate business expansion organometallic, organosilanes, synergy with Optima’s primary in Switzerland, described the business of custom and contract manufacturing business, a company spokesperson ADCs as key anti-cancer treatment platforms combining an antibody with a highly said at its showcase presentation. potent cytotoxic molecule. Additionally, Optima is now the licensed manufacturer and seller of several kinds The conjugation of the antibody to the cytotoxic drug via specific linkers of alkylithiums and lithium alkoxides. Manufacturing capabilities for any for these poses several challenges during the development and manufacturing phases. The products range from grams to metric tons. alliance between Carbogen Amcis and ADC Biotechnology aims to help ADC Optima continues to focused on the core business of custom manufacturing and innovators overcome these challenges by offering world-class chemistry skills and support services for advanced intermediates and fine chemicals to several industries access to ADC Biotechology’s proprietary solid phase immobilisation technology. including pharmaceutical, nutraceutical, bioscience, personal care, and food/flavors. Miller’s presentation included a workshop dedicated to ADCs in Switzerland and a It is a full service contract/custom synthesis manufacturer offering services over a formulation site with lyophilization capabilities in France for the supply of ADCs. comprehensive range of scale. Helsinn keeps up with trends WeylChem offers chemicals, manufacturing services Helsinn Advanced Synthesis develops and manufactures active pharmaceutical The WeylChem Group, the fine chemicals platform of International Chemical ingredients (APIs), advanced intermediates, high potency active pharmaceutical Investors Group, offers custom manufacturing services, as well as ingredients (HPAPIs) and, most recently, cytotoxic compounds for third parties under advanced intermediates, reagents, and performance products for the cGMP on an exclusive basis. The production plants, located in Biasca, Switzerland, pharmaceutical industry. were first established in 1983 and have gone through continuous expansions and Emerging from the recent consolidation of WeylChem and Elgin Fine Chemicals (former RUETGERS-Organics and Clariant Fine Chemicals custom renovations to keep up with the latest technology trends. In 1999, HAS expanded into the HPAPI market and the facilities were expanded manufacturing businesses, respectively), the combination of expertise in to include suites that utilized containment technologies. Its highly skilled team has its fine chemical units and a team of more than 900 people provides produced numerous HPAPIs in therapeutic areas including: CNS, cardiovascular, innovative, dynamically developing know-how, according to company’s respiratory, dermatology, and cancer supportive care. For HPAPIs, production scale is showcase presentation. from grams up to hundreds of kilograms. It provides a wide range of technologies on an exclusive basis for the fine Since early 2000, the plants have been ISO 14001 certified, confirming Helsinn’s chemicals market. Core chemistries are based on bromination, chlorination, commitment towards international environmental protection. The continuous work fluorination, sulfonation, oxidation, phosgenation; Grignard, Skraup and Sandmeyer on Health, Safety & Environment (HSE) also led to the OHSAS 18001 certification in reactions and Friedel-Crafts as well as C-C and Ullman Coupling reactions. 2005, in which HAS was one of the first chemical plants in Switzerland to do so. 6 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Trade Association Membership Complements Tradeshow Experience A driven event, team, and they’re in tradeshows like constant communication InformexUSA offer exhibitors with our members,” said and attendees alike the Todd Brown, Director of opportunity to make new Recruitment and Retention. business connections and “Some want the latest network with key players information on TSCA in the fine, specialty reform, while others call us and custom chemical for advice on dealing with manufacturing industry. reporters.” s a networking- “We have a 30-member For many, InformexUSA is Brown says more and among the many tradeshows more SOCMA members are and networking events they tapping into the expertise attend throughout the year. of the association’s staff, In conjunction with these which includes former events, industry executives U.S. congressional and also use their trade EPA staff, journalists, association membership marketers and financial and to strengthen connections human resources experts. and develop business Additionally, SOCMA has partnerships with those they several PhD chemists on meet. staff and is led by Lawrence According to American Sloan, a former chemical Business Magazine, 85 percent of all business failures occur in firms that are not members of their industry professional. SOCMA’s Ana Penaranda, left, senior manager of web project management and member services, and Bill Allmond, right, VP of government and public relations, listen as members share information about the industry during the 2012 InformexUSA trade show. “While many companies typically turn to a trade association for networking industry trade association. While networking is among the greatest benefits of or lobbying assistance, it’s usually the countless other things we do that help them association membership, there are other advantages, too. get the most out of their membership,” Brown explained. Organizations like SOCMA also provide leadership roles within the association, Brown urges companies to view trade association membership as an extension access to educational tools and programs, advice and referrals, and the latest news of their staff. “It’s really about knowing how to tap into the services that are going on industry drivers, trends and regulations. to help your company save time and money,” he said. “Sometimes the first step is As a trade association for specialty manufacturers, SOCMA’s staff in Washington fields daily calls and emails from members on a variety of issues, big and small. just picking up the phone and asking someone.” Visit SOCMA at Booth 2357. International Companies Find Value in SOCMA Membership S pecialty chemical companies around the globe continue to look (Booth 1800) joined SOCMA at the recommendation of the Italian Trade to the Society of Chemical Manufacturers and Affiliates Commission (ITC), which encouraged the companies to expand their (SOCMA) for the resources they need to grow their business. business opportunities through SOCMA membership. The companies are Most recently, four Italian companies and a major oilfield services also interested in participating in networking events and marketing their company joined the association to access its resources to network and businesses through a variety of services, such as SOCMA’s Marketplace market their products. and Chemical Services Directory and InformEx. “We are pleased to welcome this group of new member companies, Another significant addition to SOCMA’s membership is Weatherford which demonstrates the diversity and strength of SOCMA’s membership,” International, one of the world’s largest oilfield services companies. said SOCMA president and CEO Lawrence D. Sloan. “Our services and Weatherford (Booth #1358) joined SOCMA because of their emerging expertise in the specialty chemical industry continue to have value for chemical operations. Through acquisition and growth, Weatherford has companies throughout the world, and we encourage our incoming developed a vigorous Engineered Chemistry group, and they are looking members to take full advantage of all we have to offer.” to utilize SOCMA’s Government Relations and ChemStewards programs Italian companies ZaCh Systems (Booth 1701), Olon SpA (Booth 1703), Flamma (Booth 1802) and Lundbeck Pharmaceuticals Italy S.p.A. to help them grow their business. Visit SOCMA at Booth 2357. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Mobile Website Increased Access to SOCMA’s Chemical Services Directory I directory. chemical companies market their products and find new business with with several companies acquiring pieces of business resulting in tens of greater ease and frequency. thousands to hundreds of thousands of dollars. n response to the growing popularity of its Marketplace & Chemical Services Directory, the Society of Chemical Manufacturers and The mobile website offers the same information as the online Affiliates (SOCMA) in 2012 launched a mobile website to help The directory has been a successful tool for SOCMA members, The mobile site can be accessed at m.socmachemicaldirectory.com. Stop by SOCMA Booth #2357 for a demonstration of the Chemical Since the directory has been operational, for example: Services Directory. SOCMA is also offering a special three-month trial for n 50+ business opportunities were posted for members to explore companies attending InformEx. n Another 50 members were contacted directly by potential customers “The reality is our members and their customers probably spend more than half their time on the road instead of in front of their PC’s at the office,” said Dolores Alonso, senior director of member and marketing directly from their profiles n 10+ members are currently in some form of negotiation/exploration with companies that either contacted them or posted an opportunity services. “They stay connected via smartphones and tablets. With this ”SOCMA’s goal in developing this site is to offer mobile-friendly mobile version, they can easily navigate through the directory and find content to the widest possible audience,” said Ana Penaranda, senior business opportunities while sitting at the airport gate or in between manager for the web project. “We’ve modified the full-site template business meetings.” so it’s now designed for the smaller handheld display and touch-screen SOCMA’s directory allows users to search a network of chemical interface, allowing visitors to find information easily. Visitors can also companies based on more than 400 types of reactions and chemistries. Site access mobile-specific features such as click-to-call and location-based visitors can narrow their search by choosing from more than 200 capabilities mapping.” and services, as well as equipment and markets served. They can verify a “SOCMA is the only chemical trade association providing a tool of this company’s certification in SOCMA’s ChemStewards program, as well as other kind to the industry,” added Alonso. “Both products were developed with our performance improvement programs. The directory also allows visitors to buy members in mind and are part of the broad portfolio of benefits we offer.” and sell equipment, share documents and exchange ideas. The directory is free for members and at a cost for non-members. 7 8 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Evonik’s HPAPI Custom Manufacturing Advantage for Highly Potent Oncology Drugs Compounds to treat cancer are typically known as highly potent active pharmaceutical ingredients (HPAPIs) because they generally act at very low concentrations. High potency places substantial additional requirements on the handling and formulating of HPAPIs. In addition to FDA regulations, the manufacturer must comply with a large number of worker safety and environmental regulations to ensure the protection of employees and the environment across areas such as the laboratory, production, warehousing, and waste treatment facilities. This requires an expertise in regulations, industrial hygiene, process development, equipment design, as well as materials handling and waste treatment. Evonik operates total reactor volumes of 135 m3 for ton quantities and 35 m3 for kilogram or development quantities of HPAPIs. Containment technologies can meet Occupational Exposure Levels of < 0.1 μg/m3 air (8 hour TWA). In addition, Evonik can go from laboratory to full scale manufacturing in-house and very quickly. Evonik has a network of production sites of a size mix that makes them unique in the industry. With Tippecanoe Laboratories in the U.S., Evonik is now among the few companies worldwide with significant experience and capacity in the custom manufacturing of HPAPIs at all scales. This U.S. FDA-inspected site, with over 600 employees, possesses more than 20 years of experience in solving the problems related to the process development, production, and handling of HPAPIs. With a wide array of development and manufacturing capabilities in the U.S., such as cryogenic reactions, gas additions, and catalysis, Evonik can conduct complex synthesis of HPAPIs and their related intermediates including the synthesis of custom linkers and antibody drug conjugates commonly used in cancer therapy. This HPAPI expertise is also available in Hanau, Germany, where Evonik recently established a HPAPI process development laboratory. Leading Pharma companies trust Evonik to deliver highly potent active ingredients, from the smallest quantities for clinical trials all the way through commercial scale production. Visit Evonik at Booth 1239. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Five Minutes With… Dr. Trevor Laird to market faster, but less so on the processes for manufacture (which are often Editor-in-Chief outsourced). So there will be a need for second generation process R&D after a Organic Process Research & Development product has been launched, specifically with the aim of cost reduction. What is the focus of the journal entitled Organic Process Research and Development (OPR&D)? OPR&D is the only journal that focuses 9 What is OPR&D doing to help chemists and engineers meet/face their challenges? The journal provides an information resource on all aspects of process R&D, scale up and manufacture and each article has some “tricks of the trade” not available elsewhere in the literature. Thus, it is an aid to problem solving. That is why it is read cover-to-cover like a magazine, rather than looking at a few papers, as in a typical journal. The special issues on topics such as crystallisation/polymorphism (Feb on industrial chemical processes, describing 2013) and on Continuous Processing (2012 and hopefully again in 2014) help those the R&D and kilogram/tonne scale up that involved in process R&D and manufacture to keep up-to-date with current thinking. goes into making a chemical process economic, safe, robust and suitable for making Each year we have a special safety issue to alert chemists and engineers to plant high quality products such as pharmaceutical Active Pharmaceutical Ingredients or incidents and near misses from the past year. Agrochemicals. OPR&D not only describes high quality science but covers lots of issues such as regulatory, patents, quality by design, continuous processing, green chemistry, etc. The journal has special issues devoted to topics of current interest. Any predictions for the future of your field? There will be more pressure on cost of goods, even in generic drugs. So API manufacturers will have to focus even more on cost reduction. This will What are the major challenges chemists and chemical engineers face today? mean devising more innovative synthetic routes from lower cost raw materials, using more statistical methods of optimization (Design of Experiments, Factorial The challenge is that molecules coming into development are much more Designs) in development to get lower cost manufacture, more efforts to improve complex, yet the market desires lower cost products. So chemists and engineers process robustness to reduce batch failure and reworks, and designing small scale have to design better manufacturing processes to help keep the cost down. continuous processes for more economic manufacture. Companies (particularly biotechs) are, however, focusing more on getting products See 5 Minutes With…Organic page 15 10 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Ash Stevens Nears Completion of Multi-year Expansion Ash Stevens, a full-service contract the service and capacity needs of most pharmaceutical manufacturer, is in projects while still providing close interactive the final stages of completing a client support and project management multi-year, multi-million dollar expansion to facilitate a successful outsourcing to its cGMP manufacturing facility in experience,” said Dr. Stephen Munk, Riverview, MI. All construction on the project president and CEO of Ash Stevens. “We have is now complete. come a long way over the past 50 years and The final phase of the expansion involves are very excited to be completing this latest the commissioning and validation of a new phase of expansion at our state-of-the-art large-scale reactor bay and companion large- manufacturing facility in Riverview, MI.” scale isolation bay. Validation activities are In addition to the large-scale reactor and scheduled to be complete April 2013. The isolation bays, Ash Stevens has added many new large-scale reactor bay houses 2,000, other upgrades to its Riverview manufacturing 3,000 and 4,000 liter glass-lined vessels facility since beginning this expansion equipped with split butterfly valves and phase in 2006. These upgrades include: a appropriate engineering controls for potent hydrogenation reactor bay; a solid-state compound charging and handling. characterization laboratory that includes The new adjacent isolation bay is DSC, TGA, XRPD and PSD instrumentation; equipped with a 1.5 m2 fixed filter dryer with a laboratory with appropriate air handling glovebox technology for contained isolation, systems for the synthesis of highly potent drying, and packaging of large-scale batches. compounds; a materials storage and handling This technology permits handling of potent facility; Rosenmund filter dryers with compounds and air sensitive materials at glovebox technology; and a safety and hazard scale. assessment laboratory equipped with RC1 “With the completion of the expansion, Ash Stevens will have the capability to meet technology. Visit Ash Stevens at Booth 1552. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Five Minutes With… Aslam Malik President the industry is the accelerating pace of growth in the regulatory environment. Certain approved, planned, and potential EPA & OSHA regulations, while American Pacific Fine Chemicals (AFC) aimed at increasing public and worker safety, as written could serve to reduce What are your major concerns within your market over the next two years? U.S. Chemical/Industrial base. The market for western-based Fine & Specialty Chemical suppliers has seen an 11 the competitiveness of the U.S. Fine & Specialty Chemicals Industry. Greater governmental and regulatory entity cooperation with industry & professional association representatives during the development of these types of regulations should serve to enhance their effectiveness while limiting the negative impact to the What innovation (not your own company’s) do you believe has addressed a problem with creative solutions? Continuous processing applications to replace batch processes in key increase in demand as many customers applications is yielding real improvements in cycle times and yields while reducing have witnessed challenges from the over the size and amount of process capital expenditures. The benefits realized through reliance on perceived cost benefits offered by eastern-based suppliers. This increased continuous processing can also serve to further bridge the gap between eastern and demand can serve to encourage capex & other longer term investment by high western fine chemical production costs. quality western suppliers and is a critical part of improving our support to our pharmaceutical and related customers base. However, for these relationships to be sustainable, our customer base should recognize the critical and potentially delicate partnership role their western-based supply chain supports and proactively move to assure long-term assurance of western-based supply. What should be the common goals within the industry and/or marketplace? Our industry should continue to push and endorse the continued formal harmonization of regulatory and industrial standards both at the definition and implementation scale. This will serve to assure that manufacturers in one Among the challenges facing the industry, which one do you think is the most pressing—and why? One of the most significant challenges facing the Fine Chemicals segment of country or region know and understand the requirements and costs for full compliance across the global marketplace. Our industry should also work See 5 Minutes With…AFC page 19 2Y-Chem, Ltd, Booth 2405 Aaron Equipment Company, Booth 1424 Aarti Industries Ltd, Booth 1660 ABA Chemicals Corp, Booth 2033 ABCR GmbH & Co KG Ace Glass, Booth 1913 ACES Pharma Inc, Booth 2043 Aceto Corporation, Booth 1201 Acoris Research Ltd, Booth 2410 ACS Green Chemistry Institute, Booth 1044 Adesis Inc, Booth 1420 Advance Research Chemicals, Inc, Booth 2532 Advanstar Communications, Booth 1053 AGC Chemicals Americas Inc, Booth 1612 Agno Pharma, Booth 2006 Air Liquide Electronics, U.S.L.P, Booth 2415 Albemarle Corporation, Booth 1430 Alfa Aesar, a Johnson Matthey Company, Booth 2310 AllessaChemie GmbH, Booth 2101 AllyChem Co, Ltd, Dalian China, Booth 1408 Almac Group ltd, Booth 1313 Alphora Research Inc, Booth 1406 Altiras Industrial Services, Booth 1529 Alzchem LLC, Booth 1909 Amano Enzyme USA Co Ltd, Booth 2430 AmbioPharm, Inc, Booth 1158 American Custom Drying Co, Booth 1301 American Peptide Company Inc, Booth 1418 AminoLogics Co Ltd, Booth 2059 Ampac Fine Chemicals, Booth 2257 Ampac Fine Chemicals, Booth MR26 AMRI, Booth 1001 Amsyn Inc, Booth 1307 Anthem Biosciences Pvt Ltd, Booth 2201 APC Ltd, The Applied Process Company, Booth 2056 Apollo Scientific, Booth 2161 Apotex Fermentation, Inc, Booth 1344 Aptuit, Booth 1619 ARRAN Chemical Co, Booth 1639 Artisan Industries Inc, Booth 1021 Ash Stevens, Inc, Booth 1552 Ash Stevens, Inc, Booth MR7 A-Star Chemical Co, Ltd, Booth 1219a Astatech, Inc, Booth 1011 Asymchem Laboratories (Tianjin) Co, Ltd, Booth 2138 Asymchem Laboratories (Tianjin) Co, Ltd, Booth MR25 Aurora Filters, Booth 1150 Austin Chemical Company, Inc, Booth 1225 BASF Corporation, Booth 1439 BASF Corporation, Booth MR3 BCN Peptides SA, Booth 1029 Beijing Century RICHAP Chemistry Co, Ltd, Booth 1359 Beijing Laviana Pharmatech Co, Ltd, Booth 2124 Beijing Odyssey Chemicals Co, Ltd, Booth 2009 Beijing Tianqing Chemicals.Co,Ltd, Booth 2015 Benzo Chem Industries Pvt. Ltd, Booth 2423C Bharavi Laboratories, Booth 921H Biazzi SA, Booth 1758 BioReliance Corporation, Booth 921L Biovectra Inc, Booth 2156 Boehringer Ingelheim Pharma GmbH & CoKG, Booth 2351 Boron Molecular USA, Booth 1421 Boron Specialties LLC, Booth 1608 Borregaard Synthesis, Booth 1038 Boulder Scientific Company, Booth 1309 Browz, LLC, Booth 1620 Buchiglas USA Corp, Booth 2301 Buckman Laboratories, Booth 1912 C&EN/ACS Publications, Booth 2447 CABB AG, Booth 2350 CAC Chemical Co Ltd, Booth 1533 CalaChem Ltd, Booth 1119 Calaire Chimie S.A.S., Booth 1501 Cambrex Corporation, Booth 1539 Cambrex Corporation, Booth MR2 Cambridge Major Laboratories, Booth 2225 CAP Intelligence, Booth 2260 CARBOGEN AMCIS AG, Booth 2529 CARBOGEN AMCIS AG, Booth MR36 Carbosynth Ltd, Booth 2423E Cardolite Corporation, Booth 2221 Carus Corporation, Booth 2423D CAS, Booth 1009 Catalent Pharma Solutions, Booth 2414 CatSci, Booth 921C CCPIT Sub-Council of Chemical Industry, Booth 1521 CCR Containers, Booth 1355 Cedarburg Pharmaceuticals Inc, Booth 1207 Cedarburg Pharmaceuticals Inc, Booth MR5 CellMark Chemicals, Booth 1258 Centauri Technologies LP, Booth 1658 Central Glass International, Inc, Booth 2157 Changzhou EST Chemical Co Ltd, Booth 1459 Changzhou Sunlight Fine Chemical Co,Ltd, Booth 2011 Charkit Chemical Corporation, Booth 1649 CHEM Group, Inc, Booth 1746 Chemada / ICL-IP, Booth 1561 ChemCon GmbH, Booth 1501 ChemDesign Products, Inc, Booth 1603 ChemFuture PharmaTech (Jiangsu) Ltd, Booth 2144 Chemglass Life Sciences, Booth 2409 Chemical Week, Booth 1946 Chemicals Incorporated, Booth 1957 CHEMIK Co, Ltd, Booth 1402 Chemindustry.com, Inc, Booth 2028 Chemlex Pharmaceuticals LLC, Booth 2445 ChemNexus Inc, Booth 2230 Chemoswed, Booth 2201 Chempacific Corporation, Booth 1907 Chemspec API Corp., Booth 2450 Chemtura Corp., Booth 1548 Chevron Phillips, Booth 1712 Chifeng Yingfa Pharmaceutical Co, Ltd, Booth 1128 China Chamber of Commerce of Med. & Heal, Booth 1147a China National Pharmaceutical Foreign Co, Booth 2446 Chiral Quest Inc, Booth 1522 Chiral Technologies, Inc, Booth 2432 Chiral Technologies, Inc, Booth MR27 CiNet, Booth 1626 CiVentiChem, LLC, Booth 2153 Clean Harbors Environmental Services, Inc, Booth 1354 Colonial Metals Inc, Booth 2047 CompareNetworks Inc, Booth 1048 Contract Chemicals Ltd, Booth 1447 Corden Pharma International GmbH, Booth 1801 Corning SAS, Booth 933 CorsiTech, Booth 2331 COSMOSS VU Ltd, Booth 2110 CRI, Booth 1644 Crystallics BV, Booth 1252 CU Chemie Uetikon GmbH, Booth 1545 Custom Granular, Inc, Booth 1407 Cymer, LLC, Booth 1744 Dae Hwa Pharmaceutical Co, Ltd, Booth 1047 Daewoong Bio Inc, Booth 1144 Dalchem, Booth 2444 Dalian Joinking BioChemical Tech Co, Ltd, Booth 1249 Dalian Richfortune Chemicals Co, Ltd, Booth 1206 DanChem Technologies, Inc, Booth 2012 Danyang Wanlong Chemical Co,Ltd, Booth 1214 DavosPharma, Booth 2201 DCAT (Drug, Chemical & Associated Tech, Booth 1947 Deepwater Chemicals Inc, Booth 1461 DELMAR Chemicals INC, Booth 2049 Digital Specialty Chemicals, Booth 1160 Dishman USA, Booth 2531 Dixie Chemical Company, Inc, Booth 2231 Dottikon Exclusive Synthesis AG (USA), Booth 2119 Dr. M Inc, Booth 1758 Dr. Reddy’s Laboratories Ltd, Booth 1901 Drug Development & Delivery, Booth 1010 DSL Chemicals (Shanghai) Co, Ltd, Booth 1546 DSM Pharmaceutical Products Inc, Booth 1401 DyStar L.P., Booth 1926 Eastar Chemical Corp., Booth 2133 eChinaChem, Inc, Booth 1948 Enzyme Works Inc , Booth 2423B Enzymicals AG, Booth 1014 Equinox Chemicals, LLC, Booth 1748 Esteve Quimica, S.A., Booth 2238 Euticals, Inc, Booth 1633 Euticals, Inc, Booth MR6 Evonik Degussa Corp, Booth 1239 Evonik Degussa Corp, Booth MR8 Exova, Booth 1119 F.I.S.–Fabbrica Italiana Sintetici SpA, Booth 2049 F.I.S.–Fabbrica Italiana Sintetici SpA, Booth MR28 Far Chemical, Inc, Booth 1139 Fareva, Booth 2046 Farmabios SpA, Booth 1253 Farmhispania S.A., Booth 1259 Federal Equipment, Booth 2030 Fermion Oy, Booth 2231 Ferro Pfanstiehl Laboratories, Booth 2232 Flamma Spa, Booth 1802 FMC Lithium, Booth 1438 Fontarome Chemical Inc, Booth 1351 Frau Pharma srl, Booth 921O Fuji Chemical Industry Co, Ltd, Booth 1654 Fuji Silysia Chemical Ltd, Booth 2347 FutureFuel Chemical Co, Booth 1653 Fuzhou Sanhe Pharmachem Co, Ltd, Booth 1618 Gabriel Performance Products, Booth 1423 Galbraith Laboratories Inc, Booth 1002 Gelest Inc, Booth 1318 GFS Chemicals Inc, Booth 1930 GL Filtration Ltd, Booth 1150 Grace/Synthetech, Booth 2039 Gran Formosa Inc, Booth 921P Guangzhou Runhua Food Additive Co, Ltd, Booth 2244 GVK Biosciences Pvt. Ltd, Booth 1509 Halocarbon Products Corp, Booth 1155 Hamari Chemicals Ltd, Booth 2401 Haviland Products Co, Booth 2061 Hebei Chengxin Co, Ltd, Booth 2128 Helsinn Advanced Synthesis SA, Booth 1809 Helsinn Advanced Synthesis SA, Booth MR9 HERBRAND PharmaChemicals GmbH, Booth 1014 Heritage Environmental Services, Booth 2424 Hodogaya Chemical (USA) Inc, Booth 1261 Hongye Chemical Co, Ltd, Booth 2108 Hopax Tawain Chemical Mfg, Booth 1015 Hovione, LLC, Booth 2330 Huaian MDC Pharmaceutical Co, Ltd, Booth 1120 Hubei Greenhome Fine Chemical Co, Ltd, Booth 2248 Hydrite Chemical Co, Booth 1610 ICO Polymers North America, Booth 1621 InChem Corp, Booth 1652 InCon Processing, LLC, Booth 1613 Ind Swift Laboratories Ltd, Booth 1960 Indoco Remedies Ltd, Booth 2253 Indofine Chemical Company Inc, Booth 2206 INFA Group SpA, Booth 1225 Informex Global Pharma Sourcing, Booth 1709 Informex Sales Booth, Booth 1709 Informex Specialty Chemical Forum, Booth 1709 Ingenza Ltd, Booth 1119 Insight High Technology Co, Ltd, JiangSu, Booth 2122 Interchem Corporation, Booth 1501 International Process Plants (IPP), Booth 1908 Iofina Chemical Inc, Booth 2333 IRIX Pharmaceuticals Inc, Booth 1813 IRIX Pharmaceuticals Inc, Booth MR10 IRIX Pharmaceuticals Inc, Booth MR11 ISOCHEM, Booth 1738 Italian Trade Commission, Booth 1705 J&W Pharmlab, Booth 1027 Jan Ramakers Fine Chemicals Consulting, Booth 1119 Jiangsu Huifeng Agrochemical Co, Ltd, Booth 2001 Jiangsu Lanfeng Biochemical Co, Ltd, Booth 2104 Jiangsu Medicines & Health Prod. I&E Gro, Booth 2005 Jiangxi Renming Pharmaceutical Co, Ltd, Booth 2023 Jiangxi Time Chemical Co, Ltd, Booth 1147a Jinhong Fine Chemicals, Booth 1361 Johann Haltermann Ltd, Booth 2307 Johnson Matthey, Booth 2310 Johnson Matthey, Booth 2311 Johnson Matthey Catalysis and Chiral, Booth 2311 J-Star Research, Inc, Booth 1343 J-Star Research, Inc, Booth MR12 Julabo USA, Inc, Booth 1559 Kalexsyn, Inc, Booth 1552 Kingchem Inc, Booth 1450 Kingfirst Chemical (Nanjing) Co, Ltd, Booth 2246 KMCO Inc, Booth 1929 Kodak Specialty Chemicals, Booth 1742 Lacamas Laboratories Inc, Booth 2325 Lacamas Laboratories Inc, Booth MR13 Laohekou Jinghong Chemical Co, Ltd, Booth 1628 LAUDA-Brinkmann, LP, Booth 1607 Laurus Pvt. Ltd, Booth 1924 Laviana Corp, Booth MR23 LCI Corporation, Booth 2247 Lianhe Chemical Technology Co, Ltd, Booth 1413 Lishui Nanming Chemical Co, Ltd, Booth 2112 LIST USA Inc, Booth 2419 LOBA Chemie PVT Ltd, Booth 2024 Lonza, Booth 1052 Lonza, Booth MR15 Lonza, Booth MR16 Louisiana Chemical Equipment Co, Booth 1345 Louston International Inc, Booth 1700 Lundbeck Pharmaceuticals Italy SpA, Booth 1800 Manchester Tank & Equipment Company, Booth 1153 McGean,Inc, Booth 1511 Metallix,Inc, Booth 1448 MFG Chemical, Inc, Booth 2438 Micromacinazione SA, Booth 1225 Micron Technologies, Booth 2418 Minakem, LLC, Booth 2320 Mitrychem, Booth 1919 Mitsubishi International PolymerTrade, Booth 2500 Mitsui & Co (USA), Inc, Booth 2321 Mitsui & Co (USA), Inc, Booth MR29 Molekula Group, LLC, Booth 2423G Monomer-Polymer & Dajac Labs, Booth 2045 Morre-tec Industries, Inc, Booth 2107 MP Biomedicals LLC, Booth 1953 MRIGlobal, Booth 1314 MSU Bioeconomy Institute, Booth 2142 Muller Group, Booth 1961 Na Fluorochem(H.K) International Co, Li, Booth 1521 Nagase & Co, Ltd, Booth 2411 Nanjing Pharmatechs, Co, Ltd, Booth 2208 Nantong Kaixin Pharma Chemical Co, Ltd, Booth 1622 Nation Ford Chemical Co, Booth 1518 Navin Fluorine International Ltd, Booth 1409 Neuland Laboratories, Booth 1159 Newreka Green & Synth Technologies Pvt., Booth 2423F Niels Clauson-Kaas A/S, Booth 2201 Norac Pharma, Booth 1039 Noramco, Inc, Booth 1143 Norquay Technology Inc, Booth 1032 Northeast Pharmaceutical Group Co, Ltd, Booth 2100 Nova Molecular Technologies, Inc, Booth 1442 Novasep Inc, Booth 1939 Oakwood Products Inc, Booth 1109 Olon Spa, Booth 1703 OmegaChem, Booth 1023 ONYX Scientific, Booth 1910 Optima Chemical Group, LLC, Booth 1639 Organic Technologies, Booth 1247 Ortec Inc, Booth 1238 Panjin Xingfu Chemical Industrial Co, L, Booth 1553 Parchem Fine & Specialty Chemicals, Booth 2240 Patheon, Booth 1107 Paul O Abbe, Booth 1424 PCAS, Booth 1601 PCAS, Booth MR14 PCI Synthesis, Booth 1059 Pennakem, Booth 2318 PepTech Corp, Booth 2057 Perry Videx LLC, Booth 2327 Pharmachem, Booth 2251 Pharmacore, Inc, Booth 1303 Pharmax, Booth 2224 PharmaZell, Inc, Booth 1253 PHT International Inc, Booth 1419 Pierre Fabre Medicaments, Booth 1353 PIERS, Booth 1950 PII Pharmaceutics International Inc, Booth 2426 Piramal Healthcare, Booth 2439 POLAQUIMIA S.A. DE C.V., Booth 1312 Polypeptide Laboratories, Booth 2127 Polysciences Inc, Booth 1242 Pope Scientific Inc, Booth 1254 Porton Fine Chemicals Ltd, Booth 1453 Powdersize, Inc, Booth 1215 Pressure Chemical Co, Booth 1458 Procos USA (CBC Group), Booth 2226 PYOSA S.A. DE C.V., Booth 1526 Qi-Chem Co Ltd, Booth 1630 Qingdao Union Fine Chemical Co Ltd, Booth 1219b Quanzhou Sanwei Chemical Industry Co, L, Booth 2250 R.S.A. Corporation, Booth 1213 Regis Technologies Inc, Booth 1339 Rhodes Technologies, Booth 1706 Ricerca Biosciences, Booth 2060 Rieke Metals, Inc, Booth 2348 RightAnswer.com, Inc, Booth 1624 Robatel Inc, Booth 1352 Robinson Brothers, Booth 2219 Robinson Pharma, Booth 921G Rockwood Lithium, Booth 1659 Rodman Publishing, Booth 2146 Rohner Inc, Booth 2215 Rondaxe Pharma LLC, Booth 1648 Ropella, Booth 1346 Rx-360, Booth 2152 SABIC Innovative Plastics, Booth 1449 Sai Life Sciences Ltd, Booth 2109 Sai Life Sciences Ltd, Booth MR24 Saltigo GmbH, Booth 2131 Saltigo GmbH, Booth MR30 SantoLubes Mftg., dba Blackman Uhler, Booth 1920 SAS Institute Inc, JMP Division, Booth 2443 Scottish Development International, Booth 1119 Scynexis Inc, Booth 2339 Senn, Booth 1058 Senn, Booth MR18 Shaanxi Dasheng Pharmaceutical Tech Co, Booth 1110 Shamrock Technologies, Inc, Booth 2423P Shandong Hexing Pharmacy Co, Ltd, Booth 1212 Shandong Jiuheng Int’l Trade Co, Ltd, Booth 2252 Shanghai AQBioPharma Co, Ltd, Booth 1141 Shanghai Chemspec Corp., Booth 2450 Shanghai Record Pharmaceuticals Co, Ltd, Booth 2029 Shanghai Shyndec(Modern) Pharmaceutical , Booth 1108 Shanghai Sinofluoro Chemicals Co, Ltd, Booth 1631 Shanghai T&W Pharmaceutical Co, Ltd, Booth 1609 Shenyang Photosensitive Chemical Research, Booth 2126 Shenzhen Nexconn Pharmatechs Ltd, Booth 921K Shijiazhuang No 4 Pharmaceutical Co, Ltd, Booth 1114 Shouguang Fukang Pharmaceutical Co, Ltd, Booth 1147b Siegfried (USA), Inc, Booth 1101 Silar Laboratories, Booth 2045 Siltech Corporation, Booth 1349 Sinobright Pharmaceutical Company Ltd, Booth 2403 Sinochem Lantian Co, Ltd, Booth 1523 SK Life Science, Inc, Booth 1506 SOCMA, Booth 2357 SOCMA Member Lounge, Booth 2457 Solid Form Solutions Ltd, Booth 1925 Solvay Fluorides LLC, Booth 2239 Solvias Inc, Booth 2211 Spectrum Chemical Mfg, Corp, Booth 1944 SSI Chusei, Inc, Booth 2346 SST Corporation, Booth 2231 Strem Chemicals Inc, Booth 1319 Sumitomo Chemical Europe S.A. / N.V., Booth 2413 Suven Life Sciences USA, Booth 2125 Suzhou Everfortune Imp.&Exp. Co, Ltd, Booth 1246b Suzhou Highfine Biotech Co, Ltd, Booth 1208 Synasia Inc, Booth 1400 Syngene International, Booth 2050 SynQuest Laboratories, Inc, Booth 2159 SYNTHON Chemicals GmbH & Co KG, Booth 1922 T10 Chemicals, Booth 921D Takasago International Corp, Booth 2148 Takasago International Corp, Booth MR33 TCG Lifesciences, Booth 2147 TCI America, Booth 1940 Tekno Scienze SRL, Booth 2412 The Chemical Company, Booth 2400 Thomson Reuters, Booth 1000 Tianjin Jingye Fine Chemicals Co, Ltd, Booth 2019 TM Chemicals LP, Booth 2256 Topharman Shanghai Co, Ltd, Booth 2145 Tosoh USA Inc, Booth 1625 TrustChem Co, Ltd, Booth 2139 Ubichem Pharma Services, Booth 2433 UBM Live, Booth 1709 Umicore AG & Co KG, Booth 1131 United Biochemicals, Booth 1954 Upscale Microwave Inc, Booth 1525 US EPA Green Chemistry Program, Booth 2423i Valsynthese S.A, Booth 1501 VanDeMark Chemical, Inc, Booth 1321 Varsal Inc, Booth 1224 Veolia Environmental Services, Booth 2008 Vertellus Specialties Inc, Booth 1113 Virto/Elcan Industries, Booth 2453 Waterstone Pharmaceuticals Inc, Booth 1558 Weatherford, Booth 1358 Weihai NewEra Chemical Co, Ltd, Booth 2258 Western States Machine Corp., Booth 2345 WeylChem Corporation, Booth 1801 WIL Research, Booth 1513 Wilmington Pharma Tech Co, LLC, Booth 1702 Wockhardt Ltd, Booth 1125 WuXi AppTec Inc, Booth 2113 Xi’an Ruilian Modem Electronic Chemicals, Booth 1006 Xiangfan Goto Chemical Co, Ltd, Booth 1126 Yangzhou Chemical Co ltd, Booth 1527 Yixing Qiancheng Bio-Engineering Co, Ltd, Booth 1122 Yizheng City East Chemical Co, Ltd, Booth 1112 Zach System S.P.A., Booth 1701 Zepol, Booth 1030 Zhangjiagang Feihang Industry Co, Ltd, Booth 2027 Zhejiang Apeloa Kangyu Pharmaceutical Co, Booth 1915 Zhejiang Charioteer Pharmaceutical Co, L, Booth 2132 Zhejiang Jianfeng Haizhou Pharmaceutical, Booth 2319 Zhejiang Medicines & Health Products I/E, Booth 2005 Zhejiang Taizhou Qingquan Medical & Chem, Booth 2013 Zhejiang Tianyu Pharmaceutical Co, Ltd, Booth 2118 Zhejiang Tongfeng Pharma & Chem. Co, Ltd, Booth 2025 Zhejiang Yongning Pharmaceutical Co, Ltd , Booth 1246a Zhongdan Group, Booth 1549 Zhongdan Group, Booth MR4 14 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California CML Invests to Support Late-Phase and Commercial API Demand mid-sized pharma companies who have compounds at, or past, phase 2 clinical trials. Many contract API suppliers who have a strong base of assets to handle programs from phase 2 through launch have seen remarkable growth in their portfolio of API projects. And Cambridge Major Labs is no exception. In July of 2012, CML embarked on a major expansion of its large scale API plant in Wisconsin. Scheduled to be complete in April, the expansion will increase CML’s large scale capacity by nearly 30 percent, enabling more capacity for the large number of phase 2 and phase 3 APIs in CML’s funnel. Having a supplier that can meet the growing volume needs as APIs progress to commercialization is key to a successful new product launch; no technical transfer is required, and the API supply is effectively de-risked. Now with all this talk about late phase pipelines, we need not overlook our friends in the preclinical space; quite obviously without them, we wouldn’t be here. Over the next few years, once the clinical pipelines run their course, our pre-clinical friends will be back in full swing, With sluggishness in the pre-clinical pipelines the past few years, most of our and those of us who have assets to bring the next wave of APIs to IND will be friends in the pre-clinical toxicology space have been through numerous quarterly enjoying feast rather than famine. However, the API suppliers who have the assets reports articulating the woes of the past quarter, and the optimism that the future and personnel to accomplish all of the above will be in the best position to take (hopefully) brings. What has been largely overlooked until recently is the strength these forward—all the way to commercial with no tech transfers. of the late phase pipelines. Funding has been reasonably robust to emerging and Visit Cambridge Major Labs at Booth 2225. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California 15 PCI Launches Four Proprietary APIs, Current Generic APIs Headed Toward Commercialization PCI Synthesis, a 14-year-old phar- Newburyport plant for later stage maceutical manufacturer of new clinical development. chemical entities (NCEs), generic active The commitment to developing pharmaceutical ingredients (APIs), and other specialty chemical products, has new equipment. The contract research organization the routes of synthesis, optimizing molecules, performing process (CRO) and contract manufacturing improvements, and scaling up,” generic APIs is part of a long-standing organization (CMO) is currently involved said Ed Price, president of PCI. effort by the company to invest in in the development of four additional “The investment in developing our launched four new proprietary APIs that and develop capacity for aggressive late stage products that were included capacity has been paying off for our were initiated during 2012, increasing growth. Last year, PCI completed the in MM&M’s Pipeline 2011 list of top clients and PCI Synthesis itself by to 13 the number of exclusive generic build out of its Devens, MA-based launch prospects. enabling us to expand our experience APIs in its pipeline. facility, growing capacity by 30 percent, PCI, which provides dozens of emerging pharma clients with access to expertise for the development and manufacturing of complex small molecules to be used as NCEs, expects the current set of generic APIs to be commercialized over the next three to four years. The company also has committed to developing another three to four new products in 2013. In 2012, the company continued the clinical development of more than half dozen different NCEs for many of its Boston-area partners. Many of these products are now in the process of being scaled up in its From Organic page 9 What can subscribers look forward to seeing in OPRD in 2013? We will be introducing new features such as Virtual Issues on particular topics and we are considering introducing new sections on Best Practices and tricks of the Trade. We welcome suggestions from readers on how we can further enhance the journal and our Editorial Advisory Board meets this week in Anaheim to help drive the innovation process. Organic Process Research & Development, an American Chemical Society (ACS) publication, covers the broad field of process chemistry encompassing aspects of organic chemistry, catalysis, analytical chemistry, and chemical engineering, with special focus on the development and optimisation of chemical reactions and processes and their transfer to a larger scale, via large laboratory and pilot plant operations, for manufacture. “We have a smart team that bringing on new hires, implementing understands the complex dynamics of new cGMP systems, and purchasing small molecules, from developing and expertise. Visit PCI Synthesis at Booth 1059. 16 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Kilo Lab Centrifuges Suited for Small Scale Processing Rousselet Robatel kilo lab centrifuges Vast amounts of resources go into drug development, including time, money, and are suited for R & personnel. Choosing the right contract research organization to help with scale-up D, and small-scale projects can be tricky, considering that everyone wants to maximize value for their processing. This research dollars. centrifuge can be There are several important factors that go into CRO selection. Cost is an issue equipped with three for everyone, but other factors to consider are: experience level; facilities; and different- sized convenience. interchangeable PharmaCore, based in High Point, NC, is an example of a CRO with an rotors for processing experienced staff. Three of its five technicians have more than 20 years of multiple batch sizes. experience in pharmaceutical process development facilities like Amylin, Parke- Basket filtration Davis, and Pfizer. The three project managers each have 15-20 years of experience and solid / liquid in pharmaceutical API scale-up environments. Overseeing the GMP manufacturing sedimentation process is Brian Swierenga, VP and a chemical engineer with more than 25 years of are possible. experience in pharmaceutical research and manufacturing. Similarly, the majority of Hard- or soft-sided PharmaCore’s organic chemists hold doctorates in chemistry. containment systems can be installed for use with potent compounds. Rental equipment is available for on-site testing. Cart-mounted installation allows for easy portability and this centrifuge can be installed in a fume hood. These centrifuges can be equipped with explosion-proof electrical controls. Multiple materials of construction are available, such as 316L stainless, Hastelloy C, and other alloys. Visit Rousselet Robatel at Booth 1352. PharmaCore: Choosing the Right CRO for Scale-up Projects Commissioning an experienced CRO to work on projects is a crucial step in ensuring success in drug development programs. PharmaCore has completed work on more than 55 large-scale projects of which more than 30 of were conducted in a GMP environment. PharmaCore’s GMP pilot plant has eight GMP suites in a 35,000-sq.-ft-facility equipped for both custom organic synthesis and scale-up. The company is designed to take a project from the beginning stages of drug discovery through Phase II or III. Visit PharmaCore at Booth 1508. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Five Minutes With… Joseph A. Chiaroni 17 the USA and a less competitive Chinese economy will create growth opportunities, provided increasingly restrictive regulations do not stifle investment in the U.S. President And what do you believe are the most creative solutions? Nova Molecular Technologies responsive to customers globally will create a significant competitive advantage. Bringing lower cost and new products and services to markets faster and being Continuous improvement coupled with close partnerships in R&D or production will allow risk sharing and sustainable profitability improvement. What are your major concerns within your market over the next two years? Over the next two years, the pace of economic recovery in the world is a concern, What should be the common goals within the industry and/or marketplace? The chemical industry must strive to help create an economic environment that fosters growth, capital investment and job creation in the U.S.: low energy costs, compounded by continued slow growth or recession in Europe and major slowdown less and more flexible regulations, capital investment incentives and a level playing in China. This situation might accelerate consolidation or divestitures among chemical field among global players. companies, limiting growth opportunities for smaller players and postponing or cancelling new programs requiring capital or research and development. Among the challenges the industry faces, which do you think are the most pressing? The main challenge facing the specialty chemical industry is to adapt to slower growth and consolidation among key players. To do so, companies need What is one relevant question (and your answer) that you believe no one is addressing adequately? As a global industry player, we need a system of regulations and standards which does not penalize smaller industry players with global ambitions by erecting financial, technological or other “invisible” barriers to market penetration, especially with innovative products or services. to craft strategies linking cost competitive innovation with impeccable execution in production and customer service, to secure sustainable advantage as a valued Nova Molecular Technologies is a grassroots custom and specialty chemical partner to their customers. At the same time, by utilizing the lower energy costs in manufacturer located in Pasadena, TX. 18 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Five Minutes With… Tony Uberoi We should develop a streamlined approach to regulatory oversight. Whenever Vice President, Sales regulations are considered, peer reviewed science and rational overall assessment Gabriel Performance Products must also be a key part of the process, with a strong emphasis on cost/benefit analysis. Let’s develop practical regulations, which do not handcuff our business leaders with unnecessary bureaucracy bogging down the system. This will release resources that can be redeployed to help grow the industry. What are your major concerns within your market over the next two years? We continue to see two factors that are exerting strong influence on our business. The What should be the common goals within the industry and/or marketplace? The industry must continue to operate with a focus on outstanding environmental, first is the increasing level of regulation that health, safety and security performance (EHS&S). Beyond that we must work to improve we face, much of which seems quite arbitrary. the image of the chemical industry with key stakeholders such as regulators, politicians These new regulations increase our costs while drawing resources away from other and the general public. The chemical industry makes a significant impact on the well- developments, hampering our ability to grow. The second factor is the increasing being of mankind (via improved water, food, energy, human health, goods, safety and difficulty of identifying and hiring technical people to support our growth targets. comfort). This effort should be a multipronged approach, with industry associations working in tandem with a grassroots approach driven by individuals within the industry. Among the challenges the industry faces, which do you think are the most pressing? The most pressing challenge is how to maintain a strong economic recovery with Too often, we hear “it’s a Chemical” uttered with disdain and disgust and we let it go. One-on-one discussion can be effective at educating the public one person at a time. We must ensure our society understands the key role that chemistry plays in their lives. sustainable job growth in the U.S., while managing the ever increasing and rapidly expanding regulations that many times are not rational or based on sound science. These regulations are often counter-productive toward realizing the economic and societal benefits the chemical industry brings to the well-being of mankind throughout the world. What is one relevant question (and your answer) that you believe no one is addressing adequately? Q: The U.S. seems to forget that manufacturing was a key driver to our improved standard of living though out much of the 20th century. As we move toward a service- And what do you believe are the most creative solutions? based economy, what will fuel our continued improvement in our standard of living? q INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California p A: We believe we must return to our From AFC page 11 manufacturing roots. Increases in labor to increase public awareness of both Manufacturers & Affiliates) is proactively public school level to help promote productivity over the past seven decades the necessity and benefits addressing major issues and interest in chemistry related allowed for the improvement of wages of a viable U.S.-based Fine & Specialty opportunities facing our industry curriculums, promotion of green and general business conditions. We are Chemical industrial base. A lack of beginning with a very proactive chemistries across our industry proud that we have been in business for appreciation of the contribution of our involvement with our U.S. through an effective “ChemStewards” more than 50 years, and have been able industry can lead to uninformed Congressional leadership via a program. to add jobs over the past seven years, support of bad law and similar series of focused congressional expanding our workforce by 40 percent. limitations based on limited member interactions with professional AFC is a U.S. based custom fine With strong support from our owners, understanding and reactionary staff and a series of SOCMA chemical manufacturer of Active Edgewater Capital Partners, we continue responses to important events within member/ congress member events. Pharmaceutical Ingredients & to invest in manufacturing for growth. our industry, communities and The organization is also leading Registered Intermediates with facilities In a more favorable business climate that neighbors. technical & science education in California and Texas. rate of growth could be even higher. Let’s make the R&D tax credit permanent and look for ways to hasten the return of chemical manufacturing previously outsourced. Gabriel Performance Products specializes in chemical contract manufacturing and provides numerous epoxy curing and specialty lubricants. Umicore Registers Its API Plant with FDA Umicore recently registered its API Plant with FDA and will register the drug master files (DMF) for each of its three APIs Cisplatinum, Carboplatinum, and Oxali-platinum with FDA in the first quarter of this year. After having received CEPs for these products and several European audits for its Argentina-based plant, this is another step towards Umicore becoming the a one-stop shop for its clients’ global API needs. Registering the DMFs with the FDA will trigger an FDA audit, which is expected towards the end of the year. In light of recent bottlenecks in supply chain on the Platinum APIs, Umicore’s strategy to keep safety stocks of all products at its cGMP plant is allowing optimized lead-times when supplying products to its clients around the world. Besides meeting global quality standards for all regions, Umicore can customize CoAs according to its clients’ needs. This allows globally acting clients to benefit from a flexible product qualification for different markets. Visit Umicore at Booth 1131. SOCMA (Society of Chemical 19 initiatives at the university and 20 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Novasep Invests $4 Million to Boost HPAPI Manufacturing Capabilities chemistry at -60°C in hastelloy reactors, as well as large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale. The pharmaceutical industry increasingly demands targeted and potent drugs, such as antibody-drug conjugates (ADCs), to improve efficacy and reduce side effects especially for anti-cancer therapies. Of the 39 new molecular entities (NME) approved by the FDA in 2012, one third were cancer treatments. In this context, the new investment strengthens Novasep’s position on the global HPAPI and ADC market. With its unique combination of synthesis and purification technology in confined area—and more than 25 years of experience in the manufacture of HPAPIs—Novasep is a partner of choice for the production of highly potent toxins often required for ADCs. The experience of the FDA-inspected site in Le Mans has been recognized by SafeBridge with its certification since 2009. “Manufacturing for the life science sectors is facing a series of challenges. Drug candidates have become more specific and personalized, while the economic climate demands more cost-effective Novasep, a supplier of manufacturing solutions to the life sciences industries, and safer solutions,” said Patrick Glaser, CEO of Novasep. “Novasep’s development is investing $4 million to expand its highly potent API (HPAPI) manufacturing strategy has enabled us to anticipate these changes in the market, and today we are capabilities at its site in Le Mans, France. increasing our capability to meet future market demand. This new investment is the In the expanded cGMP facility, Novasep will perform the synthesis, purification, and isolation of highly potent compounds with an OEL (Occupational Exposure Limit) lower than 0.03 µg.m-3.8h-1 at kg- scale. The investment features cryogenic result of our continued commitment in HPAPI and our long-term collaboration with our customers.” Visit Novasep at Booth 1939. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California BioVectra: Strengthened Commitment, Continuity as API Supplier As a longstanding participant in the industry, BioVectra invites InformEX attendees to meet with its management team: Ron Keefe, CEO; Dale Zajicek, president; and Heather Delage, director of sales and marketing. BioVectra remains committed to maintaining its position as a specialized contract manufacturer and development partner. The acquisition by Questcor Pharmaceuticals ensures continuity of the BioVectra business plan, including continued execution on a number of client-partnered capital expansion projects. InformEX 2013 is the first major industry event since the acquisition where the company can present the progress it has made, and demonstrate its performance as a technologybased, cGMP API manufacturer. The company’s recent accomplishments include: the start-up and commissioning of an $18 million dedicated API manufacturing facility, a multi-ton synthetic capacity addition to address launch-preparation and commercial quantities of drug substance for a major patient population therapeutic; the ongoing $5-million expansion and qualification of a dedicated manufacturing wing for a client approaching late-stage development and filing of its product; and the completion of a second fermentation wing to produce commercial and clinical quantities of fermentation API products, extending its capabilities and experience to handle small-molecule, high potency fermentation systems. BioVectra soon will announce additional expansion plans as it continues to invest to meet the needs of customers. “We remain committed to continued growth and extension of our expertise, technologies, and manufacturing capacity,” said BioVectra president Dale Zajicek. “Questcor has consistently stated its interest in the acquisition as to ensure its own supply chain security, and diversify its business. Visit BioVectra at Booth 2156. 21 22 INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California Educational Foundation Helps Chemical Companies Develop Future Workforce The You Be The Chemist Challenge, CEF’s academic competition for grades 5-8, brings together members of the chemical industry, students, educators, and community members in celebration of science. Almost 20,000 students from around the country will participate in the program this year, scheduled for June 24. The students pictured competed in the 2012 National Challenge held in Philadelphia. T CEF partnered with The Franklin Institute in Philadelphia to conduct a You Be The Chemist Essential Elements professional development workshop with educators who participated in its challenge program. These workshops use CEF’s Activity Guide lessons to walk educators through ways to better engage students through inquiry-based learning and are sponsored by members of the chemical industry nationwide. he Chemical Educational Foundation (CEF) is a national non-profit collaboration is vital to improving the state of science education in the U.S., the organization that works to enhance science education opportunities for the future of the industry, and society as a whole. nation’s youth. It collaborates with members of the chemical industry to implement outreach initiatives in their community. CEF’s You Be The Chemist educational series includes the Activity Guides, “CEF programs serve as an avenue by which member companies of organizations such as the Society of Chemical Manufacturers & Affiliates (SOCMA) and the National Association of Chemical Distributors (NACD) show their commitment to engaging Challenge, and Essential Elements professional development programs. These students and educators in science education,” stated CEF executive director John Rice. interactive, community-based programs for students in grades K-8 are in use by “The result of these interactions is the development of a new generation of citizens hundreds of chemical companies, educational entities, and community organizations that genuinely understands and appreciates the benefits of chemistry and the chemical across the country. industry. This positively impacts the development of a workforce for the future and the These groups work together to encourage the study of science, technology, engineering, and math subjects and augment the related resources available to industry’s right to do business,” he added. Founded in 1989 and headquartered in Arlington, VA, the Chemical Educational educators and students. The chemical industry and the many volunteers that Foundation works closely with industry to enhance science education opportunities give of their time and effort in support of the programs recognize that this group for our youth. From Rx-360 page 1 volunteers to get “a ton of work done” on the Chino project and complete the job at the has helped to build or repair more than 600,000 houses, serving more than 3 Ontario site, according to Martin Van Trieste, Amgen’s senior VP of quality. “This project has been a success for everybody,” Sternquist said. “We were very million people worldwide. The Pomona excited by the enthusiasm of the group, and we were happy to see people make office, which opened in 1982, has donations as individuals and as a group. They were very much into the spirit of what completed 44 houses. we do. We just prayed that it wouldn’t rain.” Karen Seiberlich of the Amgen Van Trieste considers Habitat for Humanity a worthwhile philanthropic organization supplier quality management team because “it helps people who haven’t had nurturing, good fortune and breaks to keep contacted Pomona Valley Habitat in their families together and give their children a chance to advance in life.” October on behalf of Rx-360, which Another benefit, he said, is allowing people in Rx-360 to get to know each other recruited more than 40 volunteers for the projects. They worked on a six-building condo by working on such a good project. “We already have plans to do this again next complex in Chino and a single-family home in Ontario, according to Habitat’s Morgan year when Informex is in Miami,” he said. Sternquist. Hours priming, painting, caulking, sanding, among other tasks enabled the For more information about Rx-360, its activities and an update on the Habitat for Humanity project, visit Booth 2152. INFORMEX Show Daily | Wednesday February 20 2013 | Anaheim Convention Center Anaheim California 23 The Art of the Party Sets the Tone for a Week of Networking Nothing like a grand party to get an InformexUSA conference off to a great start. Networking and more networking was on the menu Monday evening at the C&EN-sponsored reception. Still, no one could help but also concentrate on the fine dining options: from decadent mashed potato servings in martini glasses to savory short ribs smothered mac n’ cheese plates. Mingling folks kept the party highly charged with ambitious plans for this InformexUSA 2013 iteration. Top row, left to right: Balraj Kalirai, of Robinson Brothers and Michael Holding of Contract Chemical; SOCMA’s Erica Green and Austin Alderice sandwich Mike Velotta of McGean; Shoufu Lu and Yunfei Rao of Shanghai Biopharma; Bottom row, left to right: Oakwood’s Cheri Butler, Greg Butler, and Lin Lin; and Cambrex’s George Rothermel, John Michnick, Rick Offerman, and Josh Van Kley A d v e r t i s e r s I n d e x AMPAC Fine Chemicals, Booth 2257, www.ampacfinechemicals.com. . . . . . 2 Ash Stevens, Inc., Booth 1552, www.ashstevens.com. . . . . . . . . . . . . . Cover BioVectra Inc., Booth 2156, www.biovectra.com. . . . . . . . . . . . . . . . . . . . . . 8 Cambridge Major Laboratories, Inc., Booth 2225, www.c-mlabs.com. . . . 19 C&EN, Booth 2447, cen.acs.org. . . . . . . . . . . . . . . . . . . . . . . . . . . . 17, 18, 20 Chemtura Corp., Booth1548, www.chemtura.com . . . . . . . . . . . . . . . . . . . 8 DFI Pharma, Booth 1545, www.dfipharma.com. . . . . . . . . . . . . . . . . . . . . . . 9 Evonik, Booth 1238, www.evonik.com/pharma. . . . . . . . . . . . . . . . . . . . . . 24 Fabbrica Italiana Sintetici SpA, Booth 2049, fisvi.com. . . . . . . . . . . . . . . . 11 Federal Equipment Co., Booth 2030, www.fedequip.com . . . . . . . . . . . . . 17 Helsinn Advanced Synthesis S.A., Booth 1809, www.helsinn.com. . . . . . . 10 J-Star, Booth 1343, www.jstar-research.com . . . . . . . . . . . . . . . . . . . . . . . . 14 LIST USA Inc., Booth 2419, www.list.us. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Nova Molecular Technologies, Inc., Booth 1442, www.novamolecular.com. . 9 Oakwood Products, Inc., Booth 1109, www.oakwoodchemical.com . . . . . 23 Organic Technologies, Booth 1247, www.organictech.com. . . . . . . . . . . . 14 PCI Synthesis.com, Booth 1059, www.pcisynthesis.com . . . . . . . . . . . . . . . 16 PharmaCore, Inc., Booth 1303, www.pharmacore.com. . . . . . . . . . . . . . . . 15 Ricerca Biosciences, Booth 2060, www.ricerca.com . . . . . . . . . . . . . . . . . . 21 Siegfried USA, Inc., Booth 1101, www.siegfried.ch. . . . . . . . . . . . . . . . . . . 16 Umicore AG & Co. KG, Booth 1131, www.umicore.com. . . . . . . . . . . . . . . . 7 Zach Stystem S.P.A., Booth1701, www.zachsystem.com. . . . . . . . . . . . . . . 18