It’s no secret that cell and gene therapies are advancing at a rapid pace. As with any new innovations, unforeseen challenges are sure to accompany. One of the challenges generating buzz lately, is the need to define standards in the industry, specifically in the areas of apheresis collection and manufacturing. So, we’re going straight to where it begins – the cell collection, fully dependent on often unpredictable health- and human-variables.
Most collections of cellular starting material that go on for manufacture take place at one of many apheresis centers around the world. These centers collect, process, cryopreserve, and transport blood products, and adhere to a number of different requirements and protocols each day. But, even when centers are following similar protocols, it’s nearly impossible for them to generate a uniform product with each collection.
“Even when collecting from two individuals at the same center, using the same equipment, what ends up in that cell collection bag at the end of the day is going to be different from one donor to the next,” said Amy Hines, director of collection network management at Be The Match BioTherapies®.
The quality of the samples they provide often depends on their health the day of the collection. And, when collecting for autologous therapies from patients who are ill, health status can be highly variable, even by the hour.
Study results published last year by Alexey Bersenev, MD, PhD, in the journal Transfusion found that T cell counts varied considerably in samples drawn from patients at apheresis centers across the U.S. Some of the samples had such low concentrations of T cells that it was difficult to use them to engineer CAR-T therapies.
While much of this variation is due to the quirks of human biology, differences in protocols within and across apheresis centers also play a role.
For example, each collection center has its own SOP for gathering and processing starting material. Some apheresis centers are equipped for cryopreservation, for instance; others are not. Some have access to laboratories with advanced testing capabilities; others do not. Acknowledging these differences, and standardizing protocols between apheresis centers is integral to the development of any cell therapy. This is our collection network management team’s specialty, and a key area where companies can lean on our established relationships with apheresis centers throughout the world.
“Because we’ve been working with many of these centers for decades, we’re able to easily determine which centers have the capacity, equipment, and skills needed for individual therapy requirements,” according to Amy. “We then use that information, and our sound understanding of the clients’ needs, to provide knowledgeable support and ongoing training to the collection teams.”
“The apheresis centers and nurses play a hidden, but absolutely crucial, role in getting effective cell and gene therapies to patients,” Amy said. “We’re going to continue to do everything we can to support them and make sure they deliver the best quality product so companies can manufacture life-saving therapeutics.”
For additional perspectives on how standardization challenges are burdening apheresis centers, read the written interview with Amy Hines, RN, BSN, Kimberly Kasow, DO, and Sandra Hoffman, MT (ASCP) SSB, CQA (ASQ).