Products, Services, and Literature January 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

www.sartorius-stedim.com

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

www.nbsc.com/bi7.htm

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

www.biomeva.com