Cell-Based Product Manufacturing
Some of the challenges companies face with stem cells, according to Alan Smith, Ph.D., CEO and president of Cognate Bioservices, include having adequate facilities, appropriate cleanrooms, and processes that can be scaled-up and manufactured under GMP.
“We also find people looking for help with regard to developing appropriate quality control release testing and information on what the FDA is looking for in this area. I think a lot of people, especially small companies, don’t have a comprehensive understanding of good manufacturing practice and what that entails.” Dr. Smith adds that his company helps identify suitable reagents that are compatible with GMP and helps with receipt and testing of raw materials.
In addition, it provides stem cell services, including development of cell-based therapeutics using bone marrow cells for tissue repair and regeneration. He explains that there are differences in processing stem cells based on their source. Bone-marrow-derived stem cells are typically in single cells in suspension versus adipose stem cells, which are tissue-based.
“Working out those to optimize yields in manufacturing is often time consuming and critical because the cost of goods for the product is dependent on the number of stem cells one can derive from the starting material.”
Additional challenges in regards to stem cells include reliability and robustness of the process to yield consistent outcomes. To address this, the company breaks the operation down into segments: procurement, shipping/logistics, manufacturing, scale-up, and quality control, said Dr. Smith.
“We try to build in fail-safes to each of those aspects in addition to the quality control of the product that’s in tandem to the manufacturing process.” He adds that the firm has developed some techniques that allow for certain aspects of the stem cell process to occur in a closed-system fashion. The company is currently expanding its stem cell capabilities, including additional types of stem cells such as cord blood.
Although the promise of stem cell therapy started with the first successful bone marrow transplants in 1968, it is just beginning to reach the clinic. Thanks to companies’ success in developing new technologies and methods of isolating, growing, and producing adult stems cells, their quality and quantity is increasing. There still remain many hurdles—such as regulatory and financial—before they can be used to treat patients. Yet, many companies remain optimistic that working together with the FDA will create a standard of quality that will help move the field from the bench to the bedside.