Small biotechs in early development of cell therapies are often surprised by the strictness of commercial manufacturing standards. That’s the view of Luděk Sojka, PhD, CEO of contract developer and manufacturer SCTbio.

Sojka, who spoke at the Terrapinn conference on advanced therapies earlier this year, believes this is why companies should approach a CDMO as early as possible.

“Early-stage biotechs can be really surprised that you need to document everything and describe each step in your process,” he explains. “But the GMP manufacturing standards criteria are very strict.”

Moving from a non-GMP process to a GMP process late in development can be a challenge, he adds, especially for companies with limited prior experience in GMP environments.

“We see a lot of projects from small facilities in academic institutions that already have GMP certification and the documentation in place,” he explains.“But we also have projects from academic environments that don’t have access to a GMP-certified facility, or where the developers want to get started with a CDMO right away.”


Starting materials

Another challenge is starting materials. Companies often believe the process of quality control (QC) and releasing batches is simple once they have a process in place. However, in reality, the cells of each patient may behave differently leading to problems with product validation, says Sojka. “You need a very robust process to accommodate the variability of starting materials for autologous CAR-T therapies.”

A CDMO can assist by devising robust QC batch release tests early in development. Sojka believes biotechs can also be unaware of the importance of a close partnership with your CDMO, including agreeing to write down all the details of your manufacturing process.

“There must be trust, you must exchange data, and you must believe in each other,” he emphasizes, and urges biotechs working on cell therapies to approach a CDMO with a track record of working with cells, even if it’s not the exact cell type used in their therapy.

Having a company who can work with them to source starting materials and distribute their product is also important, according to Sojka.

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