January 1, 2008
Validation
Service: Confidence leachables and extractables testing
Applications: Single-use equipment validation
Features: Proprietary analytical techniques have been developed to detect low levels of extractables (including high-performance liquid chromatography, liquid and gas chromatography with mass spectrometry, and Fourier-transform infrared spectroscopy; testing is conducted with each test component in contact with the actual pharmaceutical formulation; other tests offered include bacterial challenge and viability testing, integrity test values analysis, and chemical compatibility testing
Contact Sartorius Stedim Biotech
Fermentation
Product: BioFlo Pro fermentors with ControlLogix controller
Applications: Pilot- and production-scale growth of cells and their by-products (e.g., proteins, biofuels, viral vacines)
Features: With an Allen Bradley ControlLogix controller for advanced system regulation and easy data exchange with auxiliary bioprocessing systems (such as clean-in-place skids); ISA S88-compatible for batch process control; ethernet connection with optional open process control (OPC) server connectivity and a 21 CFR Part 11 SCADA package; modular components enable rapid delivery and customization
Contact New Brunswick Scientific
Protein Production
Product: Trimer Tag expression enhancement
Applications: Trimeric protein production
Features: Patented technology allows pharmaceutical and biotech companies to design and produce any secreted therapeutic proteins in trimeric form by taking advantage of the natural properties of collagen; technology can complement or replace the Fc-Tag technology that has been used to produce dimeric proteins used in blockbuster biotech products and targeting trimeric ligand TNF-α as well as open up new avenues for targeting trimeric ligands
Contact GenHunter
Serum Free Media
Product: ProNS0 protein expression media
Applications: Recombinant protein production in NS0 cells
Features: Consists of two optimized formulas to cover the broadest range of NS0 nutritional needs; maximization of protein production is possible by titration with companion lipid supplement; simplifies product purification, enhances lot-to-lot consistency, and reduces regulatory burdens
Contact Lonza
www.lonzabioscience.com/prod.pronso
Media Optimization
Product: CHO CD EfficientFeed kit
Applications: Fed-batch CHO-based cell culture
Features: Comes with two feed supplements (1 L of each) and a detailed manual that guides users through decisions relating to chemical or physical compatibility; chemically-defined, serum-free CHO media can be used to increase productivity by up to five times that of batch conditions; feeds promote higher protein yields or cell growth kinetics, making maximum protein amounts and more cells for seeding bioreactors available in shorter time
Contact Invitrogen
www.invitrogen.com/bioproduction
Contract Manufacturing
Service: Production alliance
Applications: Manufacturing technology platform includes formulation development for microbial-derived products
Features: Two companies have entered into a production alliance agreement that allows Biomeva GmbH nonexclusive access to Boehringer Ingelheim’s comprehensive manufacturing technology platform; one innovative E. coli project regarding an antibody fragment has been transferred smoothly from Boehringer Ingelheim to Biomeva GmbH; the collaboration provides integrated solutions and accelerates the development and production of biopharmaceuticals, reducing time to market
Contact Biomeva GmbH
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