With the recent introduction of regulatory pathways for follow-on versions of complex biologics, the role of analytical technologies in comparing biosimilars with the corresponding reference product is attracting substantial interest in establishing the development requirements for biosimilars. This session will present strategies and techniques for developing product characteristics and comparability studies to meet the regulators’ requirements. This year, during the Molecules portion of the Biopharmaceutical Development and Production Week taking place February 27-March 1, 2013, we have several speakers who will come together and look at this topic in-depth:
- Late Stage Analytical Development of Biosimilars and the “Totality of Evidence” Concept
- Hans-Martin Mueller, Ph.D., Associate Director, BioProcess Development, Merck & Co.
- Paradigms for Biotech/Biosimilar Product Characterization and Comparability
- Nadine M. Ritter, Ph.D., Senior Analytical Consultant, Biologics Consulting Group, Inc.
- Freedom-To-Operate Issues in Cell Line Development
- George C. Yu, MSc., J.D., Counsel, Schiff Hardin LLP.
For more information about these sessions and the rest of the agenda, download the brochure here. If you register today, mention code BDPW13BLOG you'll save $300 off the standard rate!
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