Choosing a cell and tissue culture medium is a critical step in ensuring the quality and performance of your cultures. For cell therapy manufacturers, this choice can also affect the safety of your cell therapy. With the wide selection of culture media available, it is essential to have clarity on how each supplier defines their culture media and to understand the associated implications for product performance, safety, and compliance.
Definitions for Our Media and Supplement Formulations
Our cell culture media and supplements are available in a variety of different formulations. The formulation you choose will depend on your intended application and any regulatory compliance requirements.
For more information on specific products or for assistance with choosing a culture medium for your application, please contact Product & Scientific Support at firstname.lastname@example.org.
Assessing the Safety of Culture Media as Ancillary Materials
In the translation from bench to bedside, determining the safety of ancillary materials (AMs; referred to as raw materials in Europe) used to manufacture therapies is critical for clearing the path to the clinic. For culture media in particular, qualification as an AM in cell and gene therapy applications can be challenging due to the lack of a universal system for defining media formulations, leaving researchers and regulators to navigate the multitude of available options and definitions that can vary substantially between suppliers.
One way to assess a culture medium for AM use is through its “viral-safe profile”, which traces the risk of viral exposure from the AM, specifically from the raw materials used to manufacture it and how those raw materials themselves were manufactured. Regulators expect traceability through to the secondary raw material level, so it is not sufficient to provide evidence of the animal-free nature of an AM’s primary-level raw materials alone. Importantly, supplier claims around animal components in cell culture media are NOT standardized, so it is critical that you work with your supplier to evaluate their claims, such as by obtaining documented evidence through a detailed Certificate of Origin (CoO).
Taking the above approach, you can then “grade” culture media based on the relative ease of verifying their viral safe profile. For example, AOF media has no animal components at all, so it is easy to verify. Although it can be more burdensome to collect evidence of a viral-safe profile for products that contain animal components, it is not impossible to do so, particularly if your supplier works closely with you.
At STEMCELL, we will work with you to provide viral-safe evidence and documentation as available. Importantly, documentation to support the viral-safe profile of our cGMP products—including media containing animal components—is available as a Certificate of Analysis (CoA) and a detailed CoO.