T cell therapy is in the spotlight once again. This week, Science Translational Medicine dedicated an entire special issue to immunotherapy. Among the articles and perspective, the journal published a review, by Ton Schumacher at Netherlands Cancer Institute and Carl June at the University of Pennsylvania, on the regulatory and manufacturing hurdles currently facing T cell therapy as it fights its way to market. The review, accessible via this link, highlights hurdles such as lack of standardization and scale up when laying down the path for T cell therapy to wider market acceptance. Scale-up manufacturing is a significant concern for therapies that, by the time regulatory filings are underway, have only been manufactured in smaller clinical batches. These manufacturing runs have to be scaled up in ways that will not compromise the efficacy criteria that have been established for the cellular product ahead of the manufacturing campaigns, and thus avoiding to jeopardize any regulatory claims. Moreover, personalization of T cell therapies introduces a new set of criteria which further convolutes simple paradigms for immunotherapy that had been established before.
At the recent 13th International Congress on Targeted Anticancer Therapies, Prof Antoni Ribas at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles discussed the current commercial climate around T cell therapy and claimed that we are now at the cusp of a shift in tide wherein there is enough evidence to know that such therapies work, and, as consequence, we should expect more commercial investment in the further commercialization of such approaches.
You can watch the interview here.
Akron Biotech is part of this shift moving forward: we have been involved in the entire process of cell therapy development – from planning through to raw material qualification and supply and manufacturing and process validation for more rapid regulatory approval – and are innovating in those areas. We are always happy to answer any questions about your process – contact us here.
In related news, Akron Biotech has this week been featured in the Sun Sentinel in an editorial feature. CEO Claudia Zylberberg discussed recent developments at the company, including our recent expansion to a larger facility and much more. Read the feature here.