Tuesday, 2 February 2016

Raw materials of biological origin for the production of cell-based and gene therapy medicinal products


A new chapter has been added to the European Pharmacopeia (5.1.2) on raw materials of biological origin for the production of cell-based and gene therapy medicinal products. The chapter is for information only and not legally binding.

The chapter includes sections on the risk, origin, production of and quality requirements for raw materials of biological origin used for the production of cell-based and gene therapy medicinal products for human use.

The chapter aims to assist stakeholders in ensuring raw materials are of suitable quality and to foster harmonisation in the qualification practices and standards to be applied.


This chapter was published in the 9th Edition of the European Pharmacopoeia and became effective on 1 January 2017.



 Posted by Dr. Tim Sandle