Stem cell manufacturers need platforms in a variety of media, including standard media, specialty cell culture media, and non-animal origin supplements that support a safe and sustainable supply of their cell therapy products.
Using a recombinant enzyme like CellPrime® rTrypsin, cells can be efficiently detached from the microcarrier and then quickly separated when processed through a normal flow filtration-based microcarrier separation device.
To ensure commercial success, manufacturers must optimize their processes and abide by strict regulatory documentation requirements. Merck provides a comprehensive Regulatory Information Package for each cell culture media. This package simplifies the registration processes and includes, among others, a Certificate of Analysis, GMP Statement or TSE/BSE Certificate.
Merck also assists in development of analytical methods, transfer of analytic procedures, and consulting on other analytical methods for individual media and applications. In addition, independent on-site analytics are available to optimize and troubleshoot existing processes.