Raw materials for the production of cell-based and gene therapy products
3 April 2013
Hundreds of raw materials are used in the production of cell based and gene therapy products. However, a large number of these are only available in research or in vitro grades, which means it is difficult to assure their quality, safety and consistency.
An increasing need for guidance for the quality requirements of raw materials used in the production of cell based and gene therapy products has been recognised both by manufacturers of such products and regulatory authorities. In order to meet the needs of the field, the European Pharmacopoeia Commission decided in November 2011 to elaborate a text covering the quality of these raw materials.
This symposium will bring together users and manufacturers of such raw materials and other interested parties to discuss issues of mutual interest and to exchange experiences. This will enable the RCG Working Party to develop quality requirements for these raw materials for inclusion in the European Pharmacopoeia.