BioPharm International-04-01-2006

BioPharm International

From the Editor in Chief: GMPs and Drug Development

April 01, 2006

Columns and Departments

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In recent years, FDA has made positive moves to foster innovation by streamling regulation. But the agency's recent proposal to exempt manufacturing for phase 1 clinical trials from GMP requirements seems ill advised.

Cleaning Polyethersulfone Membranes After Ultrafiltration-Diafiltration in Monoclonal Antibody Production

April 01, 2006

Articles

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In the pharmaceutical industry, ultrafiltration (UF) membranes are used extensively in the downstream purification of recombinant proteins or monoclonal antibodies. However, the fouling of membranes after a unit operation?especially when recombinant proteins or monoclonal antibodies are highly concentrated?is a common problem. Typically, normalized water permeability (NWP) of a membrane can be reduced to about 20 percent of its original permeability at the end of an ultrafiltration-diafiltration (UF-DF) operation.

Final Word: Think Safety and Use Common Sense to Meet New IND GMP Regulations

April 01, 2006

Columns and Departments

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On January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.