CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
Course - Berlin, Germany
The Chemistry, Manufacturing & Controls (CMC) landscape of biologics is undergoing rapid development and constant change. Manufacturing processes now include transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars have been in the marketplace in Europe for almost a decade, and are now under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Organization: The Center for Professional Innovation & Education
(Courtesy of Hilton Berlin, via commons.wikimedia.org)
CMC Regulatory Compliance for Biopharmaceuticals, Biosimilars and Other Biologics
Wed, May 14, 2014 - Fri, May 16, 2014
The Berlin Hilton
Mohrenstrasse 30, Berlin, Germany
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