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Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.
The need for preclinical testing expertise is growing as molecular complexity increases.
A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.
August 01, 2011
Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.
Supplier differentiation is increasingly important in the highly competitive arena of pharmaceutical outsourcing.
The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.
The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.
An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.
Avantor reviews its experience with the Rx-360 shared audit pilot program, which is aimed at protecting the pharmaceutical supply chain. This article is part of a special issue on Outsourcing.
July 28, 2011
The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a World Health Organization presentation.
July 21, 2011
The pharmaceutical industry and US regulatory bodies have not responded adequately to the increasing level of outsourced manufacturing in countries such as China and India, according to a new white paper by the PEW Health Group.
July 14, 2011
FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction.
July 02, 2011
FDA, in cooperation with IPEC, is building a spectral library of excipients to detect improper ingredients within a drug product on site.