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