Use of porcine trypsin used in the manufacture of human biological medicinal products - Scientific guideline

This document covers the viral safety aspects of human biological medicinal products using porcine trypsin.

Keywords: Porcine trypsin, adventitious agents, virus

Current effective version

Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products

Adopted Reference Number: EMA/CHMP/BWP/814397/2011 Summary:

This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin. Although specific guidance and specification has been given for bovine sera used as cell culture reagent in manufacture of human medicinal products (CPMP/BWP/1793/02, Ph. Eur 2262 Bovine Serum), no guidance has been given so far for porcine trypsin.

Document history

Overview of comments received on guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products

Reference Number: EMA/CHMP/BWP/574033/2013 Summary:

Overview of comments received on 'Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products'

(EMA/CHMP/BWP/814397/2011)

Draft guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products

Draft: consultation closed Consultation dates: 01/03/2013 to 31/08/2013 Reference Number: EMA/CHMP/BWP/814397/2011 Summary:

This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin.

Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/BWP/367751/2011 Summary:

Porcine trypsin is a common reagent used during the manufacture of biological medicinal products for the detachment of cells from the culture vessel for their passage. At manufacture of some vaccines, trypsin is added to the final culture stage at virus production for activation of the virus. In addition, for the manufacturing of specific recombinant proteins (e.g. insulin), trypsin is used as a reagent during the downstream process.