Cell therapy companies large and small face challenges in securing the raw materials they need for their research and therapy production.
That was the message delivered by industry veteran Amy Hines, director of Collection Network Management, Be The Match BioTherapies, at this year’s Cell & Gene Therapy World, hosted by Phacilitate last month in Miami.
Amy, who manages both the Be The Match BioTherapies’ current apheresis collection network as well as the build-out strategy for prospective clients, participated in a panel titled: “Starting Material Optimization for Autologous and Allogeneic Cell & Gene Therapies.” She noted that cultivation and management of consistent, high-quality starting material is essential for research, development and production of viable cell and gene therapies. But, securing a reliable supply chain can be difficult, she warned.
Amy works with a network of more than 80 apheresis centers across the country, and recognizes that many of them face challenges, including maintaining adequate staffing, complying with both FDA and international regulations, and handling numerous protocols with specific requirements for donor and cell material throughout the supply chain. Collection methods, cell count, cryopreservation, labeling, packaging and shipping are all mandated by the end use.
“There can be upwards of 30 protocols within an apheresis center, whether it’s for autologous, related or unrelated donor programs, for clinical research or for commercial use,” Amy says. Infrequent use of particular protocols further complicates the process, as an apheresis center’s familiarity with a protocol can impact consistency and quality.
“You must be aware of the concerns and issues that apheresis centers face, and work with them to secure a quality cellular product to meet your manufacturing needs,” Amy says.
Because Be The Match BioTherapies works with apheresis centers across the country, it can develop and manage collection networks for clients, and ensure that starting material is collected and delivered consistently and with high standards. “What we can do, from a collection network management perspective, is provide guidance and a single point of contact to negotiate through some of these challenges,” Amy says.
In addition to addressing supply chain challenges, Cell & Gene Therapy World covered issues including M&A, manufacturing, pricing challenges and reimbursement models. On the heels of a year that saw the first cell and gene therapies approved by the U.S. Food and Drug Administration, industry enthusiasm was at a high, Amy said, and attendance at the Cell & Gene Therapy World was strong.