In Focus: GMP-grade cell culture
Good manufacturing practice (GMP) encompasses a set of quality control and assurance standards that ensure products used in various biopharmaceutical and biotechnological applications meet high quality standards. In the context of cell therapies, GMP guidelines are particularly important for the media and reagents used in their development and manufacture.
Cell culture media are used throughout the maintenance and expansion of living cells, which form the final cell therapy product and will eventually be introduced into the patient’s body. Using GMP-grade products ensures that quality controls and standards are adhered to in order to ensure the safety of the cells being used.
In this In Focus feature, we’ll explore the benefits of using GMP-grade media, such as ensuring product consistency and efficacy, preventing contamination and how it can facilitate regulatory approval and accelerate the time to market for cell therapy products.
Infographic
Utilizing GMP-grade products for cell therapy manufacturing
What are GMP-grade products and how do they impact cell therapy manufacturing? This infographic explores the impact GMP-grade products have on patient safety, product consistency and efficacy, traceability and documentation and obtaining the necessary regulatory approvals for the clinical application of cell therapies.
Interview
Biomanufacturing with GMP cell culture media: an interview with Maximilian Gert-Kleint
We spoke to Maximilian Gert-Kleint, Material Compliance Officer at PromoCell GmbH (Heidelberg, Germany), about what it means for cell culture media to be GMP-compliant and the significance of this in the context of cell therapy manufacturing. Maximilian also gives us his perspective on the future of cell culture media for cell therapy applications.
”GMP grade” is a branding term used by PromoCell to denote reagents that are manufactured at the PromoCell manufacturing facility in Heidelberg, Germany, under strictly controlled processes to meet stringent product specifications and customer requirements. Reagents manufactured at PromoCell are produced according to EXCiPACTTM GMP standards, a quality management system that builds on our ISO 9001:2015 certification and the ANSI certification. Risk assessment procedures are carried out at the customer site.
In association with
