The latest issue of BioProcess International focuses on product development, featuring articles on biological characterization, culture method comparison, mouse model genetic engineering, continuous processing limitations, and includes a CMC Forum Report on combination products.
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Outsourcing: Who, What, When, Where, and How
Biopharmaceutical outsourcing has changed over the years. In this Featured Report the authors explore the increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on both sides of the relationships; and the criticality of navigating the uncertainties of working with different quality organizations. Issues that affect decisions to outsource include cost, converging quality systems, change management, and staff training/expertise (including statistical capabilities).
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On 26 January 2015, CASSS hosted a program in its ongoing series of semiannual Chemistry, Manufacturing, and Controls (CMC) Strategy Forums at the Mayflower Hotel in Washington, DC. Since this series’s inception in 2002, each installment has focused on one of a wide array of topics spanning the fields of biopharmaceutical product development, manufacturing, analysis, quality, and regulation. For this forum, the program committee chose to devote a full program to a topic that was previously the focus of an…