BioPharm International
March 15, 2003
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by Gordon Kelley, BioPharm International India's rapidly growing biotech sector is infused with optimism.
March 15, 2003
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Jill Wechsler FDA explains its plan for moving most biologics under the authority of CDER. But a big question remains: What will the change do to approval times?
March 15, 2003
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by Jim Miller, Bio/Pharmaceutical Outsourcing Report Contract research organizations that provide multiple services look appealing again to big biopharmaceutical companies.
March 15, 2003
Focus on Validation
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by Anurag Rathore, Pharmacia Corporation FDA has become more knowledgeable about process chromatography ? and more demanding about column qualification. In the latest installment of BioPharm International's "Element of BioPharmaceutical Production," five industry experts share their insights on how to qualify a chromatographic column. Their advice: Write unambiguous SOPs. Focus on reproducibility of column packing. Choose appropriate metrics. And analyze your testing procedures to reduce the chance of erroneous results.
March 15, 2003
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by Stacey A. Denenberg, Vic E. Myer, and David M. Chao, Akceli, Inc.
March 15, 2003
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by David Nettleton, Computer System Validation Because perspectives of software vendors and users are different, there is no guarantee that commercial, off-the-shelf software will meet the user's requirements.