Global Marketplace
ADC Manufacturing
Cold-Chain Tracking
Product: PakSense BIOmed XpressPDF
package label
Applications: Drugs, vaccines, and
other temperature-sensitive biologics
Features: Calibrated to NIST standards,
PakSense BIOmed XpressPDF labels
help companies monitor and record
product package temperatures. The
size of a sugar packet, each waterproof
label features a USB connection that
automatically generates PDF files. Unlike
bulky recorders that read ambient
conditions, a label sensor measures the
temperature of the surface on which it
is attached once a minute. Results can
be read at a glance (LEDs indicate when
a breach has occurred). These labels fit
inside shipping containers to maximize
cargo loads.
Contact Cold Chain Technologies
www.coldchaintech.com
Australian CMO
Service: Contract manufacturing based
on mammalian cell expression
Applications: Antibodies and other
complex proteins
Features: In mid-2013, DSM will open
an 8,000-m2 contract manufacturing
facility in Brisbane, Australia. Its
≤500 kg/year capacity will come from
100% single-use upstream processing
equipment (2,000 L fed-batch culture,
500-L XD technology for commercial
manufacturing, and 250-L perfusion)
and three separate downstream
processing suites. The site will make
DSM’s proprietary XD and RHOBUST
clarification technologies available
to clients, along with conventional
bioprocessing technologies.
Contact DSM Biologics
www.dsmbiologics.com
Service: Strategic alliance between
Fujifilm Diosynth Biotechnologies UK
Ltd. and Piramal Healthcare UK Ltd.
Applications: Contract manufacturing
of antibody–drug conjugates
Features: Through a new alliance
in the United Kingdom, these
two companies offer contract
development and manufacture of
antibody–drug conjugates (ADCs).
The deal gives clients the experience
and assets of both organizations
(one in biopharmaceuticals, one in
AD conjugation) by simplifying their
supply chain and vendor-management
relationships for shortening time to clinic.
Contact Fujifilm Diosynth
Biotechnologies
www.fujifilmdiosynth.com
Contact Piramal Healthcare UK Ltd.
www.piramalpharmasolutions.com
Consultation
Lyophilization Expertise
Product Packaging
Service: Patheon Certified Consultants
Applications: Emerging biotech and
pharmaceutical companies and investors
Features: Patheon’s new consulting
capability helps address strategic and
practical questions in early, mid-, and
late-stage chemistry, manufacturing,
and controls (CMC) questions in drug
development. The “certified” consultants
are Leah Appel, Brett Berner, Lynn Van
Campen, Joe Fix, Larry Gatlin, John
Kent, Bob Lipper, Doug Mendenhall,
George Mooney, Ann Newman, Rodney
Pearlman, and Mark Staples. They add
to the company’s range of integrated
development services that includes
preformulation, formulation, analytical
development, clinical manufacturing,
scale-up, and commercialization.
Contact Patheon
www.patheon.com
Service: Contract manufacturing and
freeze-drying
Applications: Drugs and biologics
Features: At its facility in Manchester,
NH, the newly rebranded LSNE
provides aseptic drug manufacturing,
labeling and packaging, medical
device manufacturing, research and
development, quality control, and
validation services for liquid and
lyophilized products. The company
has provided lyophilization services
to pharmaceutical, biotechnology,
and medical device companies since
1997, specializing in a range of services
including cycle development and CGMP
fill–finish for both intermediary and final
products. Its facility has >2,000 ft2 of
shelf-space capacity in 24 lyophilization
units as well as 17 aseptic/nonaseptic
processing suites.
Contact Lyophilization Services of
New England www.lyophilization.com
Service: Packaging services
Applications: Vials, prefilled syringes,
bottles, and others
Features: Frazier Healthcare bought
Catalent’s commercial pharmaceutical
packaging operations based in
Philadelphia, PA, and Woodstock, IL.
The new Packaging Coordinators, Inc.
continues with the same staff under
the same management team. Catalent,
meanwhile, will focus on development
solutions and advanced delivery
technologies, clinical trial supplies,
blow–fill–seal aseptic delivery, and
integrated solutions for injectibles
— maintaining its related facilities in
Philadelphia and Woodstock. It recently
added a 3,300-ft2 aseptic fill–finish
facility in Research Triangle Park, NC.
Contact Packaging Coordinators, Inc.
www.pciservices.com
Contact Catalent Pharma Solutions
www.catalent.com
D ecember 2012
10(11)
BioProcess International 57
Global Marketplace
Cell Therapy Services
Service: Contract development and
manufacturing of cell therapies
Applications: Process development,
manufacturing, biopreservation, fill
and finish, bioassays, storage and
distribution, and related services
Features: Lonza Walkersville, Inc.
offers development, manufacturing,
and testing services for cell-based
therapeutics. With expertise in
technology and media development,
Lonza process development scientists
partner with clients to develop custom
protocols — from raw-material
requirements to process flows,
scalability, closed systems, automated
vialing, and storage/distribution. Related
services cover primary and stem cell
culture reagents, bioprocessing, and
pluripotent stem cells.
Contact Lonza Group Ltd.
www.lonza.com/custommanufacturing/biologicalmanufacturing/cell-therapy.aspx
Drug Development
Service: Ultrahigh-resolution, massspectrometric biomolecular profiling
Applications: Biomolecules
Features: This past spring, Protea
opened a new 10,000-ft2 laboratory
services facility in Morgantown, WV. It
features a Synapt G2-S high-definitiion
mass spectrometer from Waters
Corporation interfaced with Protea’s
proprietary LAESI DP-1000 direct
ionization system. This provides for
profiling molecules in biological samples
for drug–target interaction studies,
identifying unknowns, and quantifying
molecules in complex samples.
Contact Protea Biosciences Group, Inc.
www.protebio.com
Service: Vetter Development Service
Applications: Preclinical through phase
3 support for complex biologics
Features: Designed to prepare clients’
products for ultimate transfer to Vetter’s
commercial manufacturing service, VDS
operates at facilities in Chicago, IL, and
Ravensburg, Germany. The former site
provides early stage clinical production
with small-batch manufacturing, and
the latter takes products through phase
3 with enhanced analytical capabilities.
VDS Chicago has expanded its analytical
and microbial testing while adding
2,000 ft2 of GMP storage, and it plans to
add a third cleanroom for syringe filling.
VDS Ravensburg has added technologies
for syringe and cartridge siliconization
and subvisible particle detection.
Contact Vetter Pharma International
GmbH www.vetter-pharma.com
CMO Expansion
Trademark Research
Distribution
Service: Drug purification using
chromatography
Applications: Biologic active
pharmaceutical ingredients (APIs)
Features: At its facility in Mourenx,
France, Novasep is investing €30 million
to expand downstream processing for
large-volume commercial APIs. The
company stated early in October 2012
that it expected the new plant to be
built and validated within 18 months.
This follows the opening of a 2,000-m2
facility in Shanghai, China, and a
€3-million expansion of Novasep’s highly
potent API manufacturing in Le Mans,
France. The company uses simulated
moving-bed and Varicol continuous
chromatography technologies and chiral
purification. Its new plant integrates
solvent recovery systems for costeffective and environmentally friendly
processing.
Contact Novasep www.novasep.com
Service: Global Pharmaceutical Search
Applications: Pharmaceuticals
Features: Thomson Reuters’ trademark
searching and brand protection service,
Thomson CompuMark, helps companies
search globally for confusingly
similar trademarks early in product
development to minimize the chance
of name rejection by international
regulatory bodies. Search coverage
includes propietary quality-checked
trademark office records, web and
domain-name coverage, and US and EU
regulatory and industry-specific sources
(including drug names in use). Brand
owners can choose from US, UK, Spain,
France, Germany, Switzerland, Italy,
Benelux, and Canada registers to match
their product strategies. Results are
delivered online.
Contact Thomson CompuMark
http://trademarks.thomsonreuters.com
Service: Urgent Access
Applications: Time-sensitive delivery
Features: DDN (a Dohmen company)
recently added its Urgent Access
service for manufacturers of life-saving
products with time-sensitive delivery
requirements. This configurable supply
solution ensures patient access to
critical therapies in eight hours or
less — anywhere in the continential
United States year round. These
types of products often have specific
handling requirements as well as coldchain temperature sensitivity. DDN’s
tightly controlled distribution channel
mitigates the risk of counterfeiting, drug
shortages, and temperature excursions.
The company seeks to provide a
consultative service that goes beyond
the third-party logistics standard.
Contact DDN www.ddnnet.com
58 BioProcess International 10(11) D ecember 2012
Bioanalytical Services