About CSM Consulting, LLC
CELLS MATTER!
CSM Consulting, LLC is a service-oriented consulting firm focused on the importance of cellular starting material (CSM) in the success of allogeneic cell and gene therapy manufacturing. Quality and consistent CSM starts with carefully selected healthy donors and continues with standardized collection practices, well-developed processing protocols, and validated shipping procedures. As the field of allogeneic cell and gene therapy grows, it is essential to recognize how important the starting material is to the success and function of the final manufactured clinical product.
CELLS MATTER!
Our mission
No cell therapy company should just have to accept a poor quality or inconsistent cell product that the collection center sends them and adjust to it.
Our mission at CSM Consulting is to promote consistent and standardized cellular starting material that feeds into the manufacturing of cell-based therapies.
Our Resources
Our Principal Consultant, Jennifer Chain, PhD, CABP, supporting advisors, and sub-contractors have experience in the growth of healthy donor product collection programs at centers around the country. We have experience and expertise in donor recruitment, product collection, product testing, product processing and cryopreservation, product shipping, supply logistics, and quality and regulatory compliance. We have strong relationships with cell therapy companies and understand the needs of those companies growing in this space and moving from the use of research-grade leukopack and bone marrow products to GTP/GMP-grade products suitable for use in the manufacturing of clinical therapies. Our consultants have served on committees and collaborative working groups focused on cell therapy topics, developing regulatory standards, consistent collection and processing practices, and serving the increasing needs of the cell and gene therapy industry.
About our Founder and Principal Consultant:
Jennifer Chain, PhD, CABP
Jennifer Chain, PhD, CABP began her work as a laboratory scientist in 1998 at the Oklahoma Medical Research Foundation and earned her PhD in Immunology from the University of Oklahoma Health Sciences Center in 2005. From 2006-2013, Dr. Chain was at National Jewish Health and University of Colorado Denver for her postdoctoral fellowships. Dr. Chain’s undergraduate, graduate, and postdoctoral research focused on T cell development, activation, and function (with strong emphasis on γδ and memory T cells), cellular and molecular biology, autoimmunity, and new method development. Next, Dr. Chain served as an R&D scientist at a start-up biotech company in Oklahoma City, developing diagnostic testing platforms for autoimmune neuropsychiatric disorders. In 2016 she started up her own scientific consulting firm to offer her diverse skillset to scientists, physicians, and biotech entrepreneurs to help them advance their scientific goals.
In 2017, Dr. Chain transitioned from a consultant for the Oklahoma Blood Institute to a full-time employee concentrating on the development of new laboratory processes, manufacturing procedures, and ancillary materials made from salvage blood products. In 2021, as the Director of Research and Development at OBI, she began leading and growing a new program to help research scientists and cell therapy companies get the blood products they needed for their research and therapy development. This included the recruitment of healthy donors and optimization of collection, processing, and shipping strategies tailored to the specific needs of each client. More than 1000 cell therapy products were collected in a 3-year period under Dr. Chain’s coordination and program leadership. At OBI, Dr Chain was also instrumental in the development of 4 new blood-based products as ancillary materials for use in cell culture and cell therapy manufacturing support.
Dr. Chain has returned to independent consulting work through CSM Consulting, LLC, now focused on cellular starting material quality and consistency. She helps both collection centers and cell therapy companies in the pre-manufacturing stages of cell therapy development. She serves clients in many areas of science, including strategic design, project management, technical guidance, staff training, product manufacturing, and cellular starting material collection and procurement program growth.