Critical Factors for Industrializing Cell and Gene Therapies
Quality Attributes and Quality Assurance of Raw Materials
The use of high quality raw materials is critical to successfully drive the development and commercialization of Advanced Therapy Medicinal Products (ATMP). Even though raw materials are not intended to be part of the final ATMP they come in contact with them and therefore can have a critical influence on their quality, safety and efficacy.
One of the major control systems to ensure the safety and high quality of raw materials is Good Manufacturing Practice (GMP). Please click here to download an article about this topic that we have written for the European Biopharmaceutical Review. It describes which three major quality attributes we propose for GMP compliant manufacturing of ATMPs.
The article was published in the European Biopharmaceutical Review October 2016, pages 22-23, © Samedan Ltd. You can access the current issue of the EBR at http://www.samedanltd.com/magazine/current/12
Safe │ GMP Compliant │ Reliable