The maturing pharma pipeline of cell therapies will create opportunities for contract manufacturers, but first, capability and skills gaps must be filled, especially for autologous therapies made from patients’ own cells, an industry expert has said.
Although autologous batches are necessarily small and unique to each patient, these therapies offer numerous opportunities for service providers. Greater manufacturing demand will be needed to meet the expected coming wave of approvals; the FDA approved two chimeric antigen receptor (CAR) T-cell therapies for the first time in 2017, Kite/Gilead’s Yescarta for non-Hodgkin lymphoma and Novartis’ Kymriah for B-cell acute lymphoblastic leukaemia.
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CAR T-cell therapy involves taking the patient’s blood, extracting T-cells, and genetically engineering them to produce chimeric antigen receptors, which bind to an antigen found on tumour cells. The CAR T-cells are then infused back into the patient, where they multiply in the body and recognize and kill cancer cells.
Manufacturing autologous cell and tissue therapies
There are approximately 23 Western companies involved in contract manufacturing autologous cell and tissue therapies, according to research by PharmSource, a GlobalData Product. Notably, Lonza acquired PharmaCell’s capabilities in May 2017. Other companies involved in the manufacture of autologous cell and tissue therapies include WuXi AppTec, Belgium’s MaSThercell, Hitachi Chemical Co., Ltd., and Oxford BioMedica.
Production of viral vectors is an important part of autologous cell therapy manufacture. Also, supply chain logistics are more important than ever for these therapies, because they represent the patient’s own irreplaceable cells and are often a last-resort treatment. Quality testing is also crucial for this vulnerable population.
The increase in these therapies is requiring a new manufacturing paradigm, said Joanne Beck, executive vice president, Global Pharmaceutical Development and Operations, Celgene, speaking at the DCAT Conference in New York last week.
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By GlobalDataChallenges ahead
A challenge for the industry, said Beck, is that the manufacturing capabilities needed for autologous cell therapies are not yet common, and most CMOs are not yet competent.
Since each batch of an autologous cell therapy like CAR-T is for a single patient, this adds further complication and variability to the manufacturing process and supply chain, Beck said.
She said the industry is working hard to develop reproducible production methods for autologous cell therapies. It must identify and build competency in growing human cells, assays, automation, and in filling the skills gap among staff. Other challenges are the difficulty devising a potency assay for these therapies, and the fact that raw materials supply is often the single source.
Furthermore, the time needed to grow enough cells to re-infuse can be variable, and is currently down to 6–16 days, Beck said. Sterility testing adds to this waiting time for desperately ill patients. A suggested solution is to work with the FDA to allow the product to be shipped back to patients – and sometimes infused – while testing is happening simultaneously. If tests subsequently reveal a safety risk, antibiotics could be administered post hoc.
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