www.ispe.org/southcentral
Published by the South Central Area Chapter
Serving Louisiana, Oklahoma and Texas
Chapter Manager: Chris Clarke
Phone: 1.816.741.9484 and E-mail: ispesc@aol.com
BOARD OF
DIRECTORS
Shannon Goodson; President
Cytovance Biologics
405-626-0717
shannonwinters1@gmail.com
Mike Mills; Vice President
Mundy PharmaTech
281-530-8711
Steve Pondell; Treasurer
Integrated BioTech Solutions
281-253-7088
Amber Myers; Secretary
CRB
816-880-9800
Joe Rettinger; Past President
CSA Soliance
512-732-1210 ext. 112
Bill Shwaiko; Director
Alcon Laboratories, Inc.
817-551-4537
Joe Sullivan; Director
Alcon Laboratories, Inc.
817-551-8556
Craig Laubacher; At Large Member
CSA-Soliance
512-732-1210 ext. 113
Chris Clarke; Chapter Manager
816-741-9484
ispesc@aol.com
NEWSLETTER
March 2013, Number 1
ISPE SOUTH CENTRAL CHAPTER
PLANT TOUR
Lonza Houston Viral-based
Therapeutics Facility
HOUSTON, TEXAS
23 APRIL 2013
The ISPE South Central Chapter is pleased to offer a plant
tour of the Lonza Houston Viral-based Therapeutics facility as part of our regular education series of lectures and
networking events. The tour will include the opportunity
to see many of the production and preparation areas of the
site as well as the development and quality control laboratories. After the tour, we will meet for networking and
dinner at Pappasitos.
Lonza’s Viral-based Therapeutics specializes in the development and cGMP production of viral vaccine, viral vector
biologics, and viral immunotherapies. Their experienced
team has been involved in the manufacture and release of
Phase 1 through Phase 3 clinical trial materials for use in
the United States, Europe and Asia for nearly two decades.
They offer turn-key services ranging from viral vectors and
live viral vaccines manufacturing, viral-modified cellular
therapeutics production to high volume fill/finish in
their state-of-the-art multi-product Biosafety Level 2
(BSL-2) manufacturing facilities in Houston, Texas USA,
which is the site of the ISPE plant tour. The site offers a
complete service including process development, GMP
continued on page three
A Message from the
see many of the production and preparation areas
of the site as well as the development and quality
control laboratories. After the tour, there will be
networking and dinner at Pappasitos. Watch for
information on future events that will include the
Golf Tournament at Texas Star GC in Euless (outside of Dallas) on May 20 and a Meet & Greet in
Oklahoma City in June.
PRESIDENT
Greetings South Central
Chapter Colleagues:
If you are unable to attend this meeting, please
check with the website or future newsletters for
upcoming dinner/education events in your area.
These meetings are great way to keep up to date
with trends and changes within the pharma/
bio-pharma industry, along with keeping up with
contacts in the area. Other upcoming ISPE events
include INTERPHEX in April in New York, in
addition to numerous other training events and
conferences throughout the year. I invite you to
take a look at the ISPE.org website to see if any
of these opportunities would benefit you, your
career and your employer, as many of these are
highly specialized events, for certain aspects of
the industry. I especially encourage you to check
out the Communities of Practice (COPs) and
becoming a Certified Pharmaceutical Industry
Professional™ (CPIP™).
Welcome Spring! Can
you believe it’s almost
the end of March and
summer is just around
the corner? It’s been
a busy 2013 so far and
it’s looking like it won’t
be letting up any time
soon. What a great time
to be in the Pharma/
Biotech industry!
Thank you to all who came out to the dinner event on February 23 at the Iron Cactus in
Austin. I had the pleasure of attending and
meeting many of you from the area (and who
traveled to the area!). It was a very informative presentation and discussion led by Wit
Lehman with CRB Consulting Engineers titled:
“Re-Tasking Existing Equipment and Legacy
Facilities: The Practical Realities”. It was a timely
discussion as there are many companies consolidating and many that are trying to expand quickly and economically and this covered many of the
factors to consider when making these decisions.
I would also like to extend a very special welcome to our Young Professionals (individuals
just starting in the industry and in their first
four years after completing their university
education). I had the pleasure of meeting many
of them at the Austin meeting – what a great
group! We are very excited to have more Young
Professionals joining our Chapter and I encourage you to attend the events to increase your networking and to get involved with leadership of
the Chapter. Please feel free to contact me if you
are interested!
Please mark your calendars for our next event,
which should be interesting and informative as
well. On April 23, there will be a plant tour of
the Lonza Houston Viral-based Therapeutics
facility. The tour will include the opportunity to
In closing, I would like to thank you all for your
participation in the South Central Chapter. We
do have a very geographically broad and industrially diverse chapter and it is all of you that
make it unique and enjoyable.
Enjoy your 2013!
Shannon Winters Goodson
www.propharmagroup.com
2
SOUTH CENTRAL CHAPTER
PLANT TOUR
manufacturing of drug substances, aseptic fill
/ finish of drug product, product release testing, regulatory support and cGMP storage and
distribution.
continued from page one
The site operates multiple BL-2 cGMP suites that
utilize the latest single-use disposable technologies supporting up to 2000 L production scale
and meets both EU and US regulatory compliance standards. In addition, Lonza operates BL2
laboratory space for both process development
and Quality Control (QC) testing. Lonza offers
industry-leading experience for viral-based products from Investigational New Drug (IND) to
BLA. Few CMOs have the late-stage product development experience offered by the Lonza team,
and they understand the complexities and the
high level of scrutiny associated with viral-based
therapy products from a regulatory standpoint.
We provide cGMP manufacturing services from
cell and virus banking, to bulk drug substance
production and final drug product fill and finish.
Their experience in regulatory submissions
includes INDs, BLAs (USFDA), and MAAs (European Medicines Agency).
Lonza’s Houston site holds several proprietary
production, purification and formulation processes for the development and manufacturing of
gene therapy and viral vaccine products. In addition, their viral facility maintains access to the
PerC6® cell line and the newly formulated Permexcis® cell culture medium for optimal virus
production. Streamlined technology transfer and
successful scale-up are critical factors in earlyand mid-phase production. By engaging Lonza at
an early stage, they help ensure that the decisions
regarding cell lines and the manufacturing process are suitable for later-stage products, thereby
saving you time and money as your product
progresses through clinical development. From
process development and optimization to process
scale-up and characterization, Lonza can offer
you solutions to help you advance to the next
level. Their development services are suitable for
preclinical programs as well as for programs approaching commercial approval.
The registration form is in this newsletter. Fax the
form to Chris Clarke, Chapter Manager at (816)
746-1989 or ispesc@aol.com. Although you need
to register by April 16 for meal count purposes,
you may pay at the door with cash or check.
Make the check payable to ISPE South Central
Chapter.
There are several sponsor opportunities available
including a vendor table, dinner sponsor and
social hour sponsor. Call Chris at (816) 741-9484 if
you have questions.
www.pspaec.com
John.Hannon@CAgents.com
Tony.Thompson@CAgents.com
WWW.COMMISSIONINGAGENTS.COM
www.cgmpvalidation.com
3
keith.kettler@.crbusa.com
www.crbusa.com
www.reesscientific.com
2013 Classroom
Training
ISPE’s in-depth courses cover the entire
product lifecycle and are led by instructors
who are active in the industry.
Newton, Massachusetts USA
(Boston Area)
8 – 11 April
• Biopharmaceutical Facilities (T31)
• HVAC for Pharmaceutical Facilities (T14)
• Overview of Biomanufacturing
Processes (T24)
• Pharmaceutical Water Generation (T04)
• Q7A: Implementing Good Manufacturing
Practices (T30)
• Sterile Drug Manufacturing Facility (T12)
• Storage, Delivery and Qualification of
Pharmaceutical Waters (T23)
San Francisco, California USA
10 – 11 April
• Risk-MaPP (T41)
• Process Validation in Biotechnology
Manufacturing (T32)
• Process Validation in Biotechnology
Manufacturing (T32)
• Q7A: Implementing Good Manufacturing
Practices (T30)
• HVAC for Pharmaceutical Facilities (T14)
Indianapolis, Indiana USA
13 – 15 May
• GAMP® 5 Process Control Systems (T21)
• Sterile Drug Manufacturing Facilities (T12)
• Auditing for GMP (G07)
• Oral Solid Dosage (T10)
Register Early and Save!
www.ISPE.org/Training
www.masy.com
www.meco.com
4
ISPE INTERNATIONAL EVENTS
St. Louis, Missouri Training
20-23 May 2013
astropak.com
3-6 November 2013
ISPE Annual Meeting
Washington, DC
sixlog.com
FOR IMMEDIATE RELEASE
Pharmaceutical Execs to Gain Manufacturing Insights from Top Aerospace,
Automotive and Other Non-Pharma Industries at Unique ISPE Event
(TAMPA, FLORIDA, USA, 31 January 2013) – ISPE announced today that it will bring together top
executives from the aerospace, automotive and other non-pharmaceutical industries to share
manufacturing and quality innovations in an Executive Forum in Philadelphia, Penn. USA, 2-3 April
2013. Attendees will receive a rare opportunity to convene with world-class leaders and to gain
industry-advancing insight related to lifecycle development and management, best manufacturing
practices, supplier development, quality management systems and leadership.
“ISPE is dedicated to leading the pharmaceutical industry by addressing significant issues that have the
greatest potential to enhance manufacturing and production, quality, engineering and regulatory
matters throughout the product lifecycle. Through this all-new event, ISPE will facilitate executive-level
discussions that go beyond best practices in the pharmaceutical industry, featuring presentations from
other industries facing similar manufacturing, quality and global integration challenges,” said Nancy
Berg, ISPE President and CEO. “The discussions planned for this conference will help Members,
pharmaceutical companies and their suppliers translate solutions and lessons learned from other
industries into their own operations.”
Notable speakers at this conference include:
•
•
•
•
•
Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER), FDA, USA
Craig Kennedy, Senior Vice President, Supply Chain Management, Merck Manufacturing
Division, Merck & Co. Inc., USA
Philip Dunford, Vice President, General Manager, Boeing Military Aircraft, The Boeing
Company, USA
Ken Shead, Vice President of Quality and Manufacturing, The Boeing Company, USA
Jerry Bussell, Author of "Anatomy of a Lean Leader", President, Bussell Lean Associates,
retired Vice President of Operational Excellence, Medtronic Surgical Technologies
Pharma industry executives leading this event serving as moderators include:
•
•
•
•
Mary Oates, Vice President Global Quality, Pfizer
Andy Skibo, Executive Vice President, Operations, MedImmune
Joe Famulare, Senior Director, Global Compliance & External Collaboration, Genentech
Andy Signore, President and Founder, Institute for Strategic Growth.
More information on the 2013 ISPE Executive Forum, including complete education details and
registration information is available at www.ISPE.org/2013ExecutiveForum.
5
FOR IMMEDIATE RELEASE
2013 Facility of the Year Awards (FOYA) Winners Announced
(TAMPA, FLA. USA, 29 January 2013) – The Facility of the Year Awards Judging Panel has named six
Category Award Winners in the 2013 Facility of the Year Awards (FOYA) program. The winning projects for
2013 were selected from 27 well-qualified entries and are located in Ireland, Switzerland, the United Kingdom
and the United States.
“The FOYA program is about recognizing the pharmaceutical industry’s innovation and technical advances in
facility manufacturing, which ultimately is about helping patients who need and depend upon us for a reliable
supply of quality medications,” said Chaz Calitri, Vice President of Network Performance at Pfizer and chair of
the 2013 FOYA Judging Panel. “The six facilities honored by this year’s awards program embody innovation,
exemplified by advances in areas including flu vaccine manufacturing, which is very relevant in parts of the
world right now where outbreaks have occurred, threatening public health. All of this year’s honorees are to be
commended for their important contributions to our industry and, most importantly, to improving people’s lives.”
The winning companies and respective award categories are:
•
•
•
•
•
•
Biogen Idec, winner of the Facility of the Year Award for Facility Integration for its Flexible Volume
Manufacturing (FVM) Project in Research Triangle Park, North Carolina USA.
F. Hoffmann – La Roche, winner of the Facility of the Year Award for Project Execution for its TR&D –
Building 97 Facility in Basel Switzerland.
MedImmune, winner of the Facility of the Year Award for Equipment Innovation for its UK Automation
Upgrade Project in Speke, Liverpool UK
Merck & Co., Inc., winner of the Facility of the Year Award for Operational Excellence for its Vaccine
and Biologics Sterile Facility (VBSF) Project in Carlow Ireland
Morphotek, Inc., winner of the Facility of the Year Award for Sustainability for its Morphotek Pilot Plant
in Exton, Pennsylvania USA
Novartis Vaccines and Diagnostics, winner of the Facility of the Year Award for Process Innovation
for its U.S. Flu Cell Culture Facility in Holly Springs, North Carolina USA
More information about the 2013 Category Winners and their projects can be found at
www.FacilityoftheYear.org/FOYAWinners2013.
About the Facility of the Year Awards Program
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards
(FOYA) is an annual program recognizing state-of-the-art pharmaceutical manufacturing projects that utilize
new and innovative technologies to enhance the delivery of a superior project, as well as reduce the cost of
producing high-quality medicines. Now in its ninth year, the awards program effectively demonstrates the
accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and
advance pharmaceutical manufacturing technology for the benefit of all global consumers.
For more information, contact:
DANIELLE HOULD
Communications Manager,
ISPE
+1-813-960-2105
dhould@ispe.org
www.ISPE.org
RJ PALERMO
Vice President – Strategic Initiatives,
INTERPHEX
+1-203-840-5427
rpalermo@reedexpo.com
www.interphex.com
###
6
BILL KOENEN
Associate Publisher,
Pharmaceutical Processing
+1-973-920-7793
bill.koenen@advantagemedia.com
www.pharmpro.com
18TH ANNUAL GOLF TOURNAMENT
&
AWARDS BANQUET
MONDAY, MAY 20, 2013
THE TEXAS STAR GOLF COURSE – EULESS, TX
HOLE-IN-ONE CONTESTS
$$$ Cash, Clubs, Golf Trips, His/Hers Watches
TEAM SCRAMBLE
Sponsor Your Own Team or We Will Set You Up
First Place Awarded in Two Flights
PRIZES
Closest to the Pin, Long Drive Contests
Loads of Door Prizes and Giveaways
BUFFET DINNER AND AWARDS
Presented in the Club’s Banquet Facility
ITINERARY:
11:00 am – 12:30 pm
1:00 pm
6:00 pm – 7:30 pm
Check In & Registration
SHOTGUN START
Buffet Dinner and Awards Ceremony
REGISTRATION FORM
Golfers:
ISPE Member No.:
Sponsor Name:
Company
Phone:
Email:
ISPE Member – Golf & Buffet Dinner
Non-Member – Golf & Buffet Dinner
Vendor Sponsored Team (Members or Non-Members)
$175.00
$225.00
$700.00
Hole-in-One Sponsor – 8 Total
Banquet Sponsor
$600.00
$300.00
MAKE YOUR RESERVATION BY FRIDAY, MAY 3, 2013* TO:
Joe Sullivan
Alcon Laboratories, Inc.
Phone: (817) 551-8556
6201 South Freeway, M/C AM-17
Fax:
(817) 551-9972
Fort Worth, TX 76134
email: joe.sullivan@alcon.com
Check or cash payment – no credit cards accepted. Make check payable to “ISPE South Central Chapter”
* NOTE: Submitted registration form is Sponsors’ implied agreement for payment to participate in the event - no exceptions
Visit Texas Star Golf Course website at www.texasstargolf.com for directions.
7
ISPE SOUTH CENTRAL CHAPTER
PLANT TOUR &
DINNER EVENT
Lonza Houston Viral-based
Therapeutics Facility
ATTENDEE REGISTRATION FORM
HOUSTON, TEXAS
23 APRIL 2013
ISPE Membership #__________________________
Name______________________________________
Company___________________________________
Address____________________________________
City/State/Zip________________________________
Phone_____________________________________
Fax________________________________________
E-mail_____________________________________
Additional Attendees:
Tour the Lonza Houston Viral-based
Therapeutics Facility.
Lonza, 8066 El Rio Street,
Houston, TX 77054
Tour includes the production and
preparation area and the development
and quality control laboratories
Pappasito’s Restaurant
2515 South Loop West
Houston, TX 77054
1. ________________________________________
2. ________________________________________
Registration Fees
Member
$ 35 x______= $______
SCHEDULE OF EVENTS
Non-Members
$ 50 x______= $______
Student
$ 10 x______= $______
Vendor Table
$ 500 x______= $______
Tour
6:00 PM
Dinner Sponsor $ 300 x______= $______
Social Hour—Cash Bar
7:00 PM
Buffet Dinner
7:30 PM
Social Hour
Sponsor
$ 200 x______= $______
Total Amount
$______
PAYMENT METHOD:
REGISTER IN ADVANCE
THEN PAY AT THE RESTAURANT
Deadline for reservations is April 16, 2013.
Send the registration form to Chris Clarke,
Del Sol Buffet
sizzling beef & chicken fajitas; tender,
slow-smoked pork ribs & campfire shrimp
grilled to perfection
8601 N Overland Dr., Kansas City, MO 64154
Fax: (816) 746-1989 • Phone: (816) 741-9484
ispesc@aol.com
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