Coagulation of experts: Blood industry bonds together to solidify CGT manufacturing

“In the US, fewer than 5% of hospitals have the experience and capabilities needed to manage and administer advanced cellular therapies,” said Jeff Wren, VP of biotherapies for Association for the Advancement of Blood & Biotherapies (AABB). “This means that, even under the best conditions, the vast majority of patients cannot access these treatments.”

To address such problems, stakeholders from the blood and cell industry formed the Blood and Cell Advocacy Register (BCAR), a consortium of experts from across the industry who seek to share ideas that can benefit developers seeking to bring their novel therapies to market.

Wren and Becky Butler Cap, SVP of biotherapies at Vitalant, spoke with BioProcess Insider about the formation and future of BCAR, which launched in December 2024 to help organizations overcome major challenges in CGT development and manufacturing.

Although BCAR formerly launched last month, the discussions that led to its founding have marinated for years. BCAR has gathered voices from around the industry, representing organizations such as Terumo Blood and Cell Technologies, Blood Centers of America (BCA), OrganaBio, and BioBridge Global in addition to AABB and Vitalant. Those stakeholders bring diverse perspectives to the consortium, offering perspectives from purchasing, to marketing, to operations.

BCAR engages in virtual roundtable discussions to share ideas and is currently welcoming new members. The organization's initial goal is to meet about once per quarter in addition to contributing articles and interviews for the benefit of the industry.

“This group came together to be a joint voice for the industry,” Cap said, becoming “a quasi–think-tank advocacy group.”

Offering insight

The blood industry is uniquely positioned to offer insights that can enable advanced therapy medicinal product (ATMP) developers to launch their products successfully.

Wren said that although ATMP developers are experts at the science behind potentially life-saving therapies, they don’t always have expertise in manufacturing, regulations, and other areas that concern getting their products to patients.

He emphasized the importance of speaking with drug developers early to ensure they have the best plans for scaling their technologies as they work through clinical trials and prepare for their growing needs. Some developers, he said, may begin by working with a single blood center, whereas working with a network of centers will better prepare those companies to meet rising needs as they grow from delivering 50 doses of their lead candidate one year to 500 doses the next.

He also advised that companies speak with regulatory bodies such as the US Food and Drug Administration (FDA) early to gain an understanding of the guidances and proposals in place while sharing the blood industries interpretation of existing regulations.  

Cap added that information sharing starts with asking questions, particularly related to infrastructure, where the blood industry has thrived. For example, she asks, “Did you know that blood centers across America have been collecting product, processing it through a GMP manufacturing process, and delivering it back to a patient for 80 years, all under a regulated system?”

She stressed that to keep developers from becoming overwhelmed with demand, a robust infrastructure that enables patients to seek care close to home is necessary.

“This is really about getting to a hyper-local presence that allows patients to be treated in their communities. So it's extending and stretching that healthcare ecosystem, so patients aren't driving to these major medical centers for every step of their therapy and having to stay in residence until their surveillance period is over." In the future, as patients seek therapies for more common diseases such as rheumatoid arthritis and lupus, the need for easy access becomes even more critical.

BCAR will host a roundtable at Phacilitate’s Advanced Therapies Week on January 22, where experts will discuss and share solutions that can benefit developers in the cell and gene therapy (CGT) space. Cap said that panelists will present “real-life examples of how we have been able to deliver things that are tricky.” That includes supporting stem-cell transplants, which is a process that can have a lot of variance with different standard operating procedures (SOPs) that are used to develop different support products. “You're tailoring [the process] to a specific patient need and making that connection for therapeutic developers.”

The consortium hopes that such public discussions will generate interest in experts who wish to join BCAR and lend their unique opinions to the cause of bringing therapies to more patients.

Cap stressed that blood centers in the US are not for profit and thus unencumbered by the ultracompetitive and secretive mindsets that can stifle industry collaboration.

“We each have our own places that we play in the industry,” she said, “but those all connect back to this joint mission.”