Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product
August 1st 2011The 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.
Evaluating QbD's Impact on the Outsourced Relationship
August 1st 2011An 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.
Rx-360 Completes Pilot Audit of Manufacturing Facility: An Industry Case Study from Avantor
August 1st 2011Avantor 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.