As the cell therapy space has matured, companies have begun to find solutions to many of the challenges around clinical trial design and execution. However, commercializing cell therapies at scale will involve finding solutions to a whole new set of challenges around manufacturing, shipping and regulatory logistics.
At the first annual Process Considerations for Cryogenic and Regenerative Medicine Commercialization Workshop, powered by Cryoport and co-sponsored by McKesson, Fisher BioServices and GE Healthcare, logistics professionals from across the cell and gene therapy industry gathered to discuss challenges and solutions in cryogenic management, regulatory requirements and best practices for processes in the support of regenerative medicine commercialization.
Held at the Marconi Automotive Museum in Tustin, Calif., the two-day workshop provided a forum for industry experts to engage in transparent discussions around critical considerations in the development and commercialization of cell therapies.
“It was great to be in a forum where companies were open with one another about the challenges they are facing and how they are attempting to solve them,” said Jamie Margolis, Ph.D., director of product development operations, Be The Match BioTherapies®, who presented at the workshop.
In her presentation Margolis discussed MatchSource® technology and its capabilities, including the ability to support highly personalized cell supply chains. “The ultimate goal of MatchSource®,” Margolis said, “is to offer a way to provide standardization to the industry by ensuring that all steps along the entire cell therapy supply chain are properly managed.”
Amy Hines, director of collection network management, gave a presentation on strategies for mitigating risk in apheresis center management, and also focused on the topic of standardization.
“When a human being is the donor, there are always going to be inconsistencies,” Hines said. “We provide end-to-end case management to ensure that despite the obstacles that may arise, we are always collecting a quality, consistent product.”
All in all, the workshop provided an exciting venue for tackling some of the biggest challenges facing cell therapy companies, and for connecting with industry professionals from across the country.