Process Control’s Increasing Role in Biosimilar Approval

Regulators are moving the comparability goalpost, shifting the burden of proof from massive clinical trials to deep process understanding. In this new landscape, the ability to define and control CPPs is the only way to ensure a biosimilar remains highly similar to its reference.

Join Bioprocess Online’s Jon O’Connell for a virtual Q&A with experts exploring how QbD principles and an understanding of reference product CQAs should guide biosimilar process development to smooth the path to regulatory approval.

This Bioprocess Online Live event will feature industry veterans, biosimilars experts and principal consultants who will offer guidance and insight you won’t want to miss.