Development of bioreactor protocols for stem cell‐based therapies

Abstract

AbstractStem cell‐based therapies offer a new treatment alternative for individuals suffering from devastating disorders such as Parkinson's disease (PD) and Huntington's disease (HD). Derivation and transplantation of stem cells or their derivatives have shown significant therapeutic outcomes in animal model studies and clinical trials. However, commercialization of stem cell‐based therapies and widespread access to these treatments are largely hampered by access to large quantities of high‐quality products generated under standardized, robust, and controlled conditions. Over the last three decades, the Pharmaceutical Production Research Facility (PPRF) of the University of Calgary, founded by the late Professor Leo A. Behie, has carried out groundbreaking research focusing on the fundamentals of bioprocessing for various stem cells including human neural precursor cells (NPCs) and mesenchymal stem/stromal cells (MSCs). These efforts led to the development of serum‐free growth media and expansion protocols for large‐scale production of therapeutically‐relevant NPCs for the treatment of neurodegenerative disorders. Similarly, high‐performance, defined growth media and reliable, large‐scale computer‐controlled bioreactor protocols were developed for the expansion of MSCs derived from human bone marrow and other sources and the generation of a therapeutically‐relevant secretome. Important bioprocessing considerations such as the hydrodynamics of the bioreactor, mass transfer, cellular microenvironment and synergistic impact of media components were evaluated in these studies. Undoubtedly, the diverse topics of research carried out at PPRF significantly contributed to the translation of the laboratory‐based stem cell culture studies into production of clinical‐grade materials and eventually commercialization of stem cell‐based therapies through applying principles of bioengineering and bioprocessing.