QA/QC Strategy for Biopharmaceuticals and Biologics
Course - Berlin, Germany
In the eyes of regulatory authorities, the quality issues of biologics are definitely different from chemical drugs because of: (1) use of living source materials to produce the biologic, (2) increased complexity of biologic manufacturing processes and (3) increased complexity of the biologic molecules themselves. While chemical drugs can become generics, biologics products are best viewed as biosimilars, and not as bio-generics.
Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as barriers to entry, testing to confirm absence, and inactivation/removal – are essential. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities (e.g., host cell proteins, host cell DNA).
Organization: The Center for Professional Innovation & Education
(Courtesy of The Berlin Hilton, Germany, via commons.wikimedia.org)
QA/QC Strategy for Biopharmaceuticals and Biologics
Wed, May 07, 2014 - Fri, May 09, 2014
The Berlin Hilton
Mohrenstrasse 30, Berlin, Germany
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