BioPharm International, April 2006 - BioPharm International

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BioPharm International, April 2006
Featured Article
PEGylation of Proteins: A Structural Approach
By A. Sorina Morar, PhD , Jeffrey L. Schrimsher , Mark D. Chavez
The type of reactive moiety controls the site and stability of the covalent link and also the total number of PEGylation sites on a given protein.
Articles
Cleaning Polyethersulfone Membranes After Ultrafiltration-Diafiltration in Monoclonal Antibody Production
By Yaling Wu , Amal Ahmed , Ruta Waghmare , David kahn
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.
The Best Targets for Biogenerics
By Charles E. DiLiberti
Of all the protein products on the US market, at most 75 are likely to become genericized.
Columns and Departments
Final Word: Think Safety and Use Common Sense to Meet New IND GMP Regulations
By James A. Taylor, PhD
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.
StreetTalk: BioPharm Stocks: What the Pros Look For
By Brian O'Connell
Coming from Wall Street. I'm often asked what "professional" investors think about the life sciences industry.
From the Editor in Chief: GMPs and Drug Development
By Laura Bush
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.
Regulatory Beat: FDA and Industry Seek New Strategies to Curb Counterfeiting and Diversion
By Jill Wechsler
RFID is currently the most advanced tracking technology, but manufacturers need to pursue a multilayered approach . . .
Outsourcing: Bio Building Boom
By Jim Miller
Interestingly, it is companies that already have the most capacity available to them that are building even more.

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