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February 01, 2014
The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
January 31, 2014
Regis Technologies passes a recent FDA audit with no Form 483 observations.
November 02, 2013
Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.
October 02, 2013
Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
September 11, 2013
New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.
September 04, 2013
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
September 02, 2013
Are strategic partnerships in clinical research a model for CMC services?
September 01, 2013
Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.
August 02, 2013
August 01, 2013
Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.