December 1, 2012
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 Technologieswww.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 Biologicswww.dsmbiologics.com
ADC Manufacturing
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 Biotechnologieswww.fujifilmdiosynth.com
Contact Piramal Healthcare UK Ltd. www.piramalpharmasolutions.com
Consultation
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 Patheonwww.patheon.com
Lyophilization Expertise
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 Englandwww.lyophilization.com
Product Packaging
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 Solutionswww.catalent.com
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/custom-manufacturing/biological-manufacturing/cell-therapy.aspx
Bioanalytical Services
Service: Ultrahigh-resolution, mass-spectrometric 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
Drug Development
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 GmbHwww.vetter-pharma.com
CMO Expansion
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 cost-effective and environmentally friendly processing.
Contact Novasepwww.novasep.com
Trademark Research
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 CompuMarkhttp://trademarks.thomsonreuters.com
Distribution
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 cold-chain 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 DDNwww.ddnnet.com
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