Cryoport : As Cell Therapy Approvals Speed Up, Companies Struggle with Manufacturing Demands

Early approvals of upcoming cell therapies have moved up manufacturing timelinesfor many firms in the biotech space. This blaze of approvals has been ignited by positive early clinical trial data, and now manufacturers are facing the substantiallogisticalchallenges of scaling their products into the commercial stage. Critical to these therapies are their environmental conditions, especially duringtransport. Many must maintain cryogenic temperatures while en route to the patient. Poorly managedtherapy processes are very risky for the viability of these fragile treatments. Fabio Fachin, PhD, Head of Cell Therapy Engineering and Automation at Takeda, explains:'The aim of cell therapy manufacturing is to deliver a consistent product starting from an intrinsically variable starting material, often from a diseased patient, [and] that is a big task.'

Cryoportis uniquely equipped to handle an important part of this 'big task.' With the largest cryogenic dry shipper fleet in the industry,we're supporting over 400clinical trials worldwide and three commercial distributions,including Gilead's YESCARTA™ and Kite's KYMRIAH™. These autologous therapies have no room for errorduring transport, which is why Cryoportutilizes over 250,000 transit legs of data, 24/7 condition monitoring, and our specifically designed packaging to proactively mitigate the risk of these therapy shipments.

In addition to an exciting surge of approved therapies needing to address these logistical challenges, many are also anticipating future regulatory changes. One of these isthe validation and traceability of equipment. We have heard this from our partners,and we have already been addressing this with Cryport'sChain of Compliance™, providing the full traceability of our equipment and processes supporting each patient's therapy. We've also introduced ournew line ofAdvanced Therapy Shippers™, whichare guaranteed for human clinical trial and commercial products to support new gene and cell therapies through all stages of their development.

The cell and gene therapy industry isa fast-growing and fast-changing space. Cryoportis dedicated to delivering thereliability and consistency our clients need, so theycan focus on their life-changing and life-saving therapies.

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