BioPharm International-03-01-2003

by Gordon Kelley, BioPharm International India's rapidly growing biotech sector is infused with optimism.

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?

by Jim Miller, Bio/Pharmaceutical Outsourcing Report Contract research organizations that provide multiple services look appealing again to big biopharmaceutical companies.

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.

by Stacey A. Denenberg, Vic E. Myer, and David M. Chao, Akceli, Inc.

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.