Charles River Offers Program on Regulatory Guidance for the Creation of New Cell Sources
December 18, 2009 – Charles River Biopharmaceutical Services (BPS) is pleased to announce a special presentation on the topic of regulatory guidance for the creation of biologics. Entitled Regulatory Considerations in Upstream Process Development, this program is presented at the Accelerate Your Success Seminar Series in partnership with GE Wave, Selexis and Irvine Scientific and will be held at four different locations across the U.S. in the month of February.
The upstream process development of all biological products, regardless of the cell source, is regulated by guidance documents that specify the establishment and testing requirements of a multi-tiered cell banking system. The creation of new and the revision of existing guidance documents require companies to be vigilant when making new cell sources. Establishing the optimal cell source early in the process will minimize the need for duplication and comparability testing.
These presentations will highlight technological advances and approaches to accelerating your clinical development of biologics. The sessions will be moderated by experts from across the drug development consulting field. The dates and locations for the sessions are as follows:
- February 1, 2010: Cambridge, MA
- February 2, 2010: Rockville, MD
- February 4, 2010: Burlingame, CA
- February 5, 2010: La Jolla, CA
For more information about any of these four sessions, please visit http://www.irvinesci.com/seminarseries2010/.