Analytical method transfer in the biopharmaceutical industry has become a significant issue as more companies attempt/plan transfers to more locations across the world. The challenges encountered in addressing technical and regulatory requirements for method transfer will be explored during the CASSS CMC Forum “Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry” January 23, 2017 in Washington DC that I’m fortunate enough to co-chair (http://www.casss.org/page/CMCJ1700). This meeting will include presentations by regulators (FDA and Health Canada) as well as industry leaders. These meetings emphasize lively discussions and are always attended by a large number of regulators and industry leaders, providing a great opportunity to understand the most current thinking for industry and regulators!
Struggles with method transfer include technical issues as well as unclear regulator expectations. Frequently, individual companies are executing their own strategies after struggling with FDA suggestions to test for equivalency using a 2-sided student t testing with very tight criteria. Currently there is no consensus approach to when formal method transfer is required or what approach should be used. In some cases businesses have reduced/eliminated transfer plans. Some companies are taking on increased risk by submitting their own strategy in post-transfer submissions after not being able to reach agreement with regulators on their strategy in advance.
I’m presenting at the CASSS CMC Forum on a risk-based approach to method transfer consistent with both ICH and FDA guidances for method transfer. A risk-based approach can address transfer-related changes that can impact quality (e.g., passing results on material that should fail) as well as business concerns (e.g., failing material that should pass). This flexible approach reduces the burden of transferring well-controlled methods as well as identifying problematic methods where more care is required in transferring methods. Slides from a June 2016 talk are located at: http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/MWDG/2016_MWDG_StaeckerJeff.pdf.
The upcoming CMC Forum is followed by the 3-day Well Characterized Biologic Proteins meeting in the same location where Ed Moore and I can be visited at the BioPhia booth. I look forward to seeing you at the upcoming CMC Forum in Washington DC or hearing from you directly regarding questions about method transfer!
Jeff Staecker, Ph.D.
Principal Consultant, BioPhia Consulting