Gene therapies are in for an extraordinary ride over the next few years: What’s a $10B market in 2024 could grow to five times that by 2033 with increased commercialization of these novel treatments.
Driving that growth are legions of therapeutic developers poised to take their drugs to market for the first time, with 38 gene therapies already approved by the FDA and an estimate that up to 20 new cell and gene therapies will be approved per year by 2025.
Despite that promising pipeline growth, however, producing those therapies is an ongoing challenge.
In fact, market intelligence suggests clinical manufacturing is among the biggest hurdles holding back new funding for cell and gene therapies (CGTs).
Among other manufacturing challenges, CGTs require smaller, more customized batches of reagents and buffers, making them a significantly different beast than small molecules or even traditional monoclonal antibodies made at larger scales utilizing standardized reagents.
“The CGT production playbook hasn’t been written, forcing innovators to operate in an unserved white space as they seek to ‘crack the code’ of advanced therapy manufacturing,” says Stephen Gunstream, President and CEO of reagent producer Teknova.
“The existing manufacturing infrastructure was not designed to produce these new drugs,” he adds. “To solve for this challenge, the industry needs clinical-grade reagent formulations that are easily customizable, scalable, and efficiently manufactured.”
If you’re facing these challenges, this white paper is for you. Sharing insights from Gunstream along with other Teknova experts, we’ll discuss the critical requirements that gene therapy manufacturers should consider when evaluating their unique reagent needs during tech transfer from process development into clinical manufacturing.
Fierce Pharma_2024.12.
