BioPharm International-04-01-2002

Columns and Departments

April 15, 2002

by Mary Ellen Goffredo, NuGenesis Technologies Corporation Weighing the Options

by Jim Miller, PharmSource Information Services, Inc. Tough economic times have prompted CROs to reflect on their past performance and to create potential solutions for the future.

by Jane Turton, Central Public Health Laboratory and Zain Moola This case study shows that storing an ion-exchange chromatography gel in dilute alkalai, followed by removal of the solubized material, enhances gel cleaning. More material is removed from the gel during column recycling, and carry over of material from one cycle to the next is substantially reduced.

Ensuring Quality and GMP Compliance

April 15, 2002

by Joseph F. Noferi, Pharmacia GS API Biopharma and Daniel E. Worden If a process is out of control, an FDA inspector will find it, eventually. Companies that emerge as winners will be those that embrace compliance as a core business practice. Systems models provide strategic competitive advantage.

Ensuring Quality and GMP Compliance

April 15, 2002

by Nadine Ritter, and John McEntire. Determining protein concentration is one of the most important analytical methods used in the discovery, development, and manufacturing of protein products. Part 1 discusses a number of methods for analyzing samples ranging from complex mixtures to highly purified proteins.

Columns and Departments

April 15, 2002

by Roland Andersson and Richard Mynahan, Strategic Decisions Group Protect your revenues and profits from manufacturing scarcity.

by G. Steven Burrill, Burrill & Company Biotechnology offers to change the face of medicine, if big pharma doesn't stand in the way

Ensuring Quality and GMP Compliance

April 15, 2002

by John C. Anders, AAI International With the advent of proteomics, innovative protein-based pharmaceuticals are entering the drug development pipeline. Compositional analysis, protein quantitation, and absorptivity determination by amino acid analysis ensures accurate characterization of recombinant proteins, amino acids, and peptides in development, bulk, and final products.