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SUPPLY AND LOGISTICS


A perfect storm: pandemic adds further burden to


CAR-T development Despite a slow return to normal, the impact of COVID-19 is still being felt across the CAR T-cell therapy industry. Adam Zamecnik examines the pain points affecting the sector.


C


OVID-19 viral vector vaccine manufacturing has placed additional pressure on the already stretched


chimeric antigen receptor (CAR) T-cell therapy industry in terms of greater demand for key reagents, say experts. They have also seen shortages of other


important materials like plastics that are part of production. Despite improvements in the industry, the pandemic continues to affect the sector’s development. Labour shortages are adding further stress


to CAR-T manufacturing, with some experts noting that the sector remains generally understaffed. This may be felt even more strongly by academic institutions, which have seen their talent move towards private players. These stresses have been compounded by the sector’s overall growth, experts say.


Viral vectors in hot demand According to Romain de Rauville, vice president of business development at Exothera, a Belgian contract development and manufacturing company (CDMO) specialising in viral vector manufacturing for gene therapies and viral vaccines, there has been a huge increase in the demand for vaccine manufacturing capabilities since the beginning of the pandemic on top of an already overstretched industry. Rauville  in Q2 2020. Likewise, according to Fatma Aybegum


Senkesen, executive director of marketing and commercial development, cell and gene, at Lonza, the company received increased demand for viral vectors during the pandemic, including in vaccines. Additionally, the


pandemic further fuelled the supply crunch felt by the industry, she says. In this sense, players in the CAR-T space


 the capabilities of viral vector producers, particularly since these capacities are largely the same for adenoviral, lentiviral, and adeno-associated viral vector production, says Rauville. Adenoviral vectors are used in the production of AstraZeneca’s and Johnson & Johnson’s COVID-19 vaccines, as well as for Russia’s Sputnik-V and others. Lentiviral vectors are often used in CAR-T production. The demand for viral vectors used for


COVID-19 vaccines has a sense of urgency, says Rauville. While the CDMO selection process can take months, Rauville has encountered companies wanting to start work on their COVID-19 programmes in a matter of several weeks. From the perspective of a CDMO, Rauville cites the need for flexibility, which allows companies to quickly shift their viral vector production. While such pressure has reduced since the height of the pandemic, viral vector supply will likely take longer to recover. Indeed, according to Matthew Durdy, CEO of Cell and Gene Therapy Catapult, the sector saw an acute period of widespread material shortages as a result of the vaccine production drive, and the sector has likely gone past this peak. However, Rauville says that the demand for viral vectors in COVID-19 vaccines remains, while noting that the company has just signed a yet- unannounced deal to supply vectors for producing a COVID-19 vaccine. While the initial impact of the pandemic- related production crunch is no longer


Clinical Trial Supply Handbook | 37


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