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Volume 6, Issue 8 (Suppl) J Biotechnol Biomater
ISSN: 2155-952X JBTBM, an open access journal Bio America 2016
November 28-30, 2016
Page 37
Notes:
conferenceseries.com
November 28-30, 2016 San Francisco, USA
13th Biotechnology Congress
Leveraging process characterization, manufacturing process history and facility fit considerations to
improve cell culture process performance
In commercial manufacturing of biopharmaceutical products using mammalian cell culture bioprocessing, variation in
bioreactor product titer could have a significant impact on drug substance yield without having a significant effect on drug
substance critical quality attributes. Variation in titer presents potential drug supply challenges to an organization and its
patients. At commercial scale, applying any mitigation strategy to alleviate variation in bioreactor product titer faces technical
challenges for manufacturing processes that utilize semi-defined production media, varying production scales, different
process technologies and multiple manufacturing facilities. The contribution of raw material lot-to-lot variability in semi-
defined production media on product titer is well-documented. Mitigating variation in product titer due to raw material lot-
to-lot variability involves considerable in-house investment in time and resources as well as collaborations with vendors and
external partners. In this presentation, we mitigated the impact of raw material lot-to-lot variability on bioreactor product titer
by leveraging process characterization information, manufacturing process history analysis and facility fit considerations to
improve bioreactor product titer by 10% while maintaining product quality.
Biography
Edward Crabbe has completed his PhD in Kyushu University, Fukuoka, Japan. He is a Senior Scientist in the Manufacturing Sciences and Technology Division of
Bristol-Myers Squibb facility located in Syracuse. New York.
Edward Crabbe
Bristol Myers Squibb, USA
Edward Crabbe, J Biotechnol Biomater 2016, 6:8(Suppl)