Science Researcher Update

QA/QC Strategy for Biopharmaceuticals and Biologics

Written by BCI Staff | Apr 14, 2014 10:01:00 PM

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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