SAFC is to host a series of three presentations at the forthcoming BioProcess International 2010 Event, to be held from September 20-24 at the Rhode Island Convention Center, Providence, RI. The BPI event, titled ‘Accelerating and Optimizing Biopharmaceutical Process and Product Development’, will feature the following presentations from SAFC:
(1) Technology Workshop: Wednesday, 22nd September, 7.15 am (breakfast is served from 6.45 am)
Speaker: Andrew Christie, Principal Scientist, Cell Sciences & Development, SAFC a division of Sigma Aldrich
“Biological Assays for Characterization of Raw Materials Used in Mammalian Cell Culture Media Formulations”
Andrew Christie, Chas Hernandez, Scott Wilson, Sandy McNorton, Michael Wathen
Cell Sciences & Development, SAFC Biosciences, Lenexa, KS 66215
SAFC Biosciences raw materials characterization initiative was established to evaluate variability in raw materials used to formulate cell culture media and thereby improve media consistency and performance in cell culture manufacturing processes. Cell-based biological assays were developed to investigate the effects of raw materials on cell growth, production and product quality. Biological assays were designed to include appropriate indicator cell lines, assay media and conditions to detect lot-to-lot variability among raw material suppliers.
(2) Raw Materials / Supply Chain Session, case study: Wednesday, 22nd September, 9.20 am
Speaker: David Kolwyck , Technical Manager, SAFC
Supplier Perspective on Risk Assessment and Management of Critical Raw Materials for the Manufacture of Biological Therapeutics
David Kolwyck, Scott Wilson, Kami Butler, Michael Wathen
Cell Sciences & Development, SAFC Biosciences, Lenexa, KS 66215
Raw materials for the pharmaceutical industry come from a board supply chain that supports many industrial applications other then biopharmaceutical manufacturing. When these raw materials are used for biopharmaceutical manufacturing, a matrix of risk assessment tools must be employed to assess and appropriately manage the risk of the raw material to the manufacturing process that uses it. This presentation will focus on the risk factors that are considered in a supplier risk assessment and a case study in how these risk factors can be predictive in pro-actively managing higher risk raw materials. Also a model is proposed for how suppliers and pharmaceutical manufacturers can collaborate to enhance their ability to predict and manage high risk raw materials to support the continuity of supply of therapeutic drugs to patients.
(3) Cell Culture & Upstream Processing: Thursday, 23rd September, 2.30pm
Speaker: Nan Lin, Principal R&D Scientist, Cell Sciences and Development, Sigma-Aldrich
Profiling Highly Conserved MicroRNA Expression in Chinese Hamster Ovary Cells and Its Applications in Cell Engineering
We used microRNA array and quantitative RT-PCR to profile highly conserved microRNA expression in CHO cells. miR-221, miR-222, miR-125b, miR-19a and let-7b were differentially expressed in IgG producing lines. We also investigated miR-24 expression in CHO cell lines with different DHFR genotypes. The results represent initial effort towards understanding miRNA expression in CHO cells and towards using miRNAs in cell engineering.
Chair of “Cell Culture & Upstream Processing” Track: Kevin Kayser, Associate Director Cell Sciences and Development, SAFC
Further information regarding these sessions and SAFC’s presence at BioProcess International 2010 can be found here.
