Cellular therapy, tissue therapy, and other regenerative medicine modalities are continuing to advance in the health care setting. These therapies have been defined as the in vivo restoration of a given physiological function that has been damaged by disease or injury processes(1) By nature, these kind of treatments generally have less physiological side-effects as opposed to many pharmaceutical drugs which can make them more attractive for doctors and their patients.
Since many of these products cannot be sterilized prior to use without compromising functionality, it is vitally important that manufacturing processes are performed in appropriate manner to protect from adventitious contamination. This is why Cell Therapy Microbiology Consulting was designed in order to provide cell therapy manufacturers with the tools, procedures, and practices necessary to control contamination and prevent cross-contamination.
Furthermore, many fresh cell therapy products cannot be cryopreserved without affecting cell viability or potency and therefore have a short shelf-life from final manufacturing to patient infusion. In order to increase product sterility assurance and enhance patient safety, these products have a substantial need for having sterility determined using alternate or rapid microbiological methods instead of the traditional 14-day culture. Cell Therapy Microbiology Consulting can help cell therapy laboratories to identify, validate and implement alternate or rapid sterility test methods for short shelf-life cell therapy products.
(1) Reference: L. Buckler & E. Razvi., Cellular Therapy Wave Finally Cresting. Genetic Engineering & Biotechnology News. November 1, 2012.