So far, manufacturing has been a hurdle for drugmakers in the burgeoning CAR-T field—but WuXi AppTec is doing its best to change that.
The company’s CDMO, WuXi Advanced Therapies, is expanding its offerings with what it calls a “fully integrated closed process CAR-T cell therapy platform.” Included in its capabilities? Raw materials with established batch records, regulatory and technical know-how, process development, testing, quality control and oversight, and access to manufacturing facilities, it said.
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WuXi will also offer companies two modalities depending on the dose requirements they need. Each has its own set of equipment, tech and materials, which the CRO says will get new cell and gene therapies to market faster.
"We are hopeful that this new platform will not only enable groundbreaking advances in the field of cell and gene therapies, but also allow our customers to deliver innovative treatments to patients with even greater predictability and speed, saving lives in the process,” Felix Hsu, senior vice president and global head of WuXi AppTec Advanced Therapies, said in a statement.
CAR-T is a particularly hot field in the oncology arena, as last week’s abstract release for the upcoming American Society of Clinical Oncology virtual annual meeting exemplified. But when it comes to taking drugs from development to market, drugmakers so far have stumbled on account of the complex manufacturing processes required to reprogram patients’ cells.
Back in July 2018, Novartis’ Kymriah—the first CAR-T drug to hit the market—ran into manufacturing glitches, leading the Swiss drugmaker to offer doctors out-of-spec doses free of charge.
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More recently, the FDA shot down Bristol Myers Squibb’s application for multiple myeloma CAR-T ide-cel, pointing to manufacturing concerns. The pharma giant says it intends to refile its app for the drug—which was a key part of the rationale behind its $74 billion Celgene takeover—by July.