Stress studies are playing a key role for Roche/Genentech in the comparability assessments needed to support its transfer of biomanufacturing processes between sites, reflecting the time savings, sensitivity to differences, and high level of stability assurance that they provide.
At the 2015 Latin America CMC Strategy Forum held in Brazil’s capitol city Brazilia in late August, Roche/Genentech Global Biologics Manufacturing Science and Technologies (MSAT) Group Lead Mary Cromwell highlighted the role that the stress studies are playing in her company’s tech transfers.
Cromwell’s remarks have high relevance to the dialogue around lifecycle management and evolving and harmonizing the post-approval change regulatory paradigm to better accommodate the realities of global manufacturing and supply operations. Roche’s approach to evaluating biotech manufacturing site transfers suggests a potential model for what a global comparability protocol might look like if the ICH Q12 effort were to take that direction.
Cromwell began her presentation on “How to Overcome the Challenges of Stability Studies to Support Global Tech Transfers” with a review of the different forces that are driving Roche to do manufacturing relocations on a not infrequent basis.