It is clear that the manufacture of patient-specific cell therapies (PSCTs) involves unprecedented complexities. The most obvious challenge is that PSCTs, by their very nature (cells are extracted from a patient or a matched donor, processed and then returned to the patient), demand that an individual cell therapy product is made for each individual, eliminating all the efficiencies associated with traditional high-throughput drug manufacture. Furthermore, the process also differs from the manufacture of “normal” biologics on many levels, including regulatory, supply chain logistics, complexity of product attributes and the complexity of preserving and storing therapies composed of living cells. The good news? The cell therapy industry has evolved; developers, manufacturers, and regulators have all become better at addressing many of the aforementioned challenges. By working together and thinking laterally, these parties are devising innovative solutions that will make novel medical treatments a reality. But one key challenge still looms ahead: commercial-scale manufacturing.

Current PSCT production processes require an abundance of cleanroom space, operational expertise and expert personnel, and incur significant overhead costs. As a consequence, current cell therapy manufacture is generally not viable at a commercial scale.