BioPharm International-04-01-2002

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.

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.

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.