How We Define Our Culture Media and Supplements
Choosing a cell and tissue culture medium is a critical step in ensuring the quality and performance of your cultures. For cell or gene therapy manufacturers, this choice can also affect the safety of your cell or gene therapy. With the wide selection of culture media available, it is essential to have clarity on how each supplier defines their culture media and their intended uses and to understand the associated implications for product performance, safety, and compliance.
The following is an overview of how 海角破解版 defines the formulations and intended uses of our products. For more information on specific products or to request assistance with choosing a formulation for your application, please contact Product & Scientific Support at techsupport@stemcell.com.
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.
Protein-Free
- Does not contain proteins or polypeptides as ingredients.
- May contain free amino acids, dipeptides, or tripeptides derived from non-animal sources.
- May contain plant, yeast, or bacterial hydrolysates.
Chemically Defined* (CD)
- The finished product contains or used in its manufacturing processes raw materials that have a known chemical structure and concentration (e.g. small molecules, salts, carbohydrates, amino acids, fatty acids, steroids, etc.).
- The product does not contain proteins, hydrolysates, or other raw materials with a complex structure or unknown composition. The finished product does not contain or use in the manufacturing process any raw materials that are derived directly from animal (including human) tissue or body fluid.
Animal Origin-Free* (AOF)
- The finished product does not contain or use in the manufacturing processes any primary and secondary raw materials that are derived directly from animal (including human) tissue or body fluid. The tertiary raw materials may be derived from animal (including human) tissues, body fluid or cell lines.
Animal Component-Free* (ACF)
- The finished product does not contain or use in the manufacturing process any primary raw materials that are derived directly from animal (including human) tissue or body fluid.
- The product may contain recombinant animal proteins, including those produced in animal cell lines or by fermentation processes. Secondary and tertiary raw materials may be derived from animal tissues.
Xeno-Free* (XF)
- The finished product does not contain or use in the manufacturing process any primary raw materials that are derived directly from non-human animals or that are recombinant materials made from non-human animal DNA sequences.
- The primary raw materials may be purified, processed or unprocessed materials from human sources or may contain recombinant materials produced in plant, bacterial, or yeast expression systems or in human cell lines. Secondary and tertiary raw materials may be derived from animal components.
Serum-Free (SF)
- The finished product does not contain any primary raw materials that are serum, plasma or hemolymph but may contain other biological materials (e.g., tissue extracts such as bovine pituitary extract, platelet lysate, growth factors, hormones and carrier proteins).
- The primary raw materials may be processed or derived from blood, serum or plasma, e.g. albumin, transferrin, low-density lipids, hormones and platelet lysate.
*Animal-Related Product Information: For products classified as animal component-free (ACF), animal origin-free (AOF), xeno-free (XF), or chemically defined (CD), 海角破解版 Technologies verifies that raw materials meet our internal animal origin requirements. 海角破解版 relies on supplier-provided documentation for information related to ingredient origin and composition, including the use of animal-derived materials during the manufacturing process. Not all information may be known beyond the ingredient level. 海角破解版鈥檚 manufacturing and packaging facilities are multi-use.
Need Technical Assistance?
海角破解版 Technologies Product and Scientific Support is available to answer your questions and troubleshoot your protocols.
Why Definitions Matter
You can rest assured that when we claim a 海角破解版 product is cGMP-compliant, we mean that it is specifically manufactured in compliance to relevant cGMPs, rather than simply in a GMP-compliant facility. Similarly, we hold our media definitions to the strictest standards, so that you can be confident that AOF truly means AOF for all primary- and secondary-level raw materials used.
Related Resources
Qualification of Ancillary/Raw Materials for Clinical Use
Walk through the steps required to qualify ancillary/raw materials for clinical use in this ISCT-hosted webinar with Lynn Csontos, 海角破解版鈥檚 Director of Quality Affairs.
Support for Your Regulatory and Compliance Needs
Get more information about qualifying ancillary materials鈥攊ncluding how we can work with you to meet your regulatory requirements鈥攁nd find definitions to common regulatory terms.
