Platforming And The Future Of Standardized Manufacturing Chassis

Platforming downstream processes offers efficiency gains, while upstream processes are standardizing on high-intensity perfusion or fed-batch. Robust analytical data allows for modern efficiencies like single-use systems.

During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, Biologics Consulting Group Principal Consultant Vince Narbut said we're already seeing companies with biosimilar pipelines standardizing their approach to at least some of their processes while making adjustments where needed.

For companies seeking interchangeability status, our panelists agree that, as long as the data package supports the claim, process and equipment differences — for example single-use systems when the originator uses stainless steel — don't pose a big risk.