BioPharm International-04-01-2003

Product Safety and Stability

April 15, 2003

by Gail Sofer, BioReliance Dorothy C. Lister, and Jeri Ann Boose Smallest of the microorganisms, viruses depend on other cells ? like those used by biopharmaceutical manufacturers ? for reproduction. And viruses and drug products are idiosyncratic: Both the inactivation process and the product strongly influence the successful outcome. In this conclusion to the virus inactivation series, model ivruses are used to represent single- and double-stranded DNA and RNA viruses, to enable you to reach conclusions about effective inactivation methods for a range of viruses.

by John Dougherty, Eli Lilly and Company, Rohin Mhatre, Biogen, Inc., and Stephen Moore, CDER FDA and biopharmaceutical industry stakeholders reach consensus on critical issues related to the use of peptide maps as identity tests for proteins and on their usefulness for lot release tests. The results of that discussion are presented here.

Product Safety and Stability

April 15, 2003

by Patrick Clinton, BioPharm International As FDA moves toward a new vision of GMP regulations, BioPharm International asked industry experts some key quextions: What form will risk-based GMPs take? What are the benefits and costs for biotech? Will the change really encourage innovation? And, most important, can FDA leaders get field inspectors to buy into the new approach?

Columns and Departments

April 15, 2003

by Paula Shadle, Shadle Consulting When building a biotech manufacturing facility and a QC lab, which scenario do you choose ? build manufacturing first, build the QC lab first, or build both facilities simultaneously?

Columns and Departments

April 15, 2003

by Michael Kamarck, Wyeth BioPharma

Product Safety and Stability

April 15, 2003

by Stephen F. Gorfien, GIBCO Cell Culture R&D, Invitrogen Corporation William Paul, David Judd, Lia Tescione, and David W. Jayme Cell density, longevity, and expression are the economics of cell cultures in biopharmaceutical production ? and rich growth media are the investment. Glucose and glutamine are primary energy sources for culture growth, but their associated metabolic wastes can actually harm cell cultures. Adapting cell lines to reduced levels of glucose and glutamine, then feeding the culture chemically defined nutrient supplements, increases cell viability, maximizes cell density, and increases product expression.

by Lon Crosby Farmers may be the pharmaceutical producers of the 21st Century. The technology exists, and practices commonly used in agriculture can be modified to meet envisioned GMPs ? and those modifications are within reach.

Columns and Departments

April 15, 2003

by Jill Wechsler, BioPharm International Six months into its initiative to update manufacturing regulations, FDA announces a raft of changes covering warning letters, inspections, and comparability ? plus a fresh start on Part 11.