Technical / White Paper

Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing

Format: PDF file | Document type: Technical / White Paper

Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing

Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal Products, or IMPs) in multi-purpose facilities.

This flexibility has been a key enabler in ensuring a flow of novel products, frequently targeting areas of unmet clinical need.  Recent regulatory guidelines suggest that a more rigorous approach be adopted, which could lead to the demand that each IMP be manufactured in a dedicated facility.

This paper suggests an alternative approach, involving the use of a health- and science- based potency toxicity and banding scheme, which would permit early phase IMPs with limited data to be manufactured in multi-product facilities.

Related resources from Fujifilm Diosynth Biotechnologies

Supplier info centre