BioProcess International

Audit Trails, System Validation, and Regulatory Warning Trends in the Biotech and Pharmaceutical Industries

A key theme emerging from FDA complete response letters since 2018 is that data system validation is lacking in the ...
BioProcess International

Cellares and Papillon Therapeutics partner to scale orphan drug production

Earlier this week, contract development and manufacturing organization (CDMO) Cellares announced its partnership with ...
BioProcess International

Sidharth Ananthanarayan

BPI Contributor Sidharth Ananthanarayan ...
BioProcess International

Paradigm Shift in Chemistry, Manufacturing, and Controls: The FDA’s Finalized Flexible Framework for Cell and Gene Therapy Approvals

The FDA’s May 2026 guidance on cell and gene therapies provides for CMC flexibilities while insisting on quality and ...