Consider GMP manufacturing for cell therapy early in development

Smaller biotech companies developing cell therapies are often surprised by the rigor of commercial manufacturing standards. This is the view of Luděk Sojka, PhD, CEO of contract developer and manufacturer SCTbio.

Sojka, who spoke at the Terrapinn Advanced Therapies Conference earlier this year, believes this is why companies should pursue a CDMO sooner rather than later.

“Young biotechnologists may be very surprised that you need to document everything and describe every step of your process,” he explains. “But the criteria of GMP manufacturing standards are very strict.”

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

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

Raw materials

Another challenge concerns starting materials. Companies often think that the quality control (QC) and batch release process is simple once they have a process in place. However, in reality, each patient’s cells may behave differently, leading to problems with product validation, says Sojka. “You need a very robust process to accommodate the variability of raw materials for autologous CAR-T therapies.”

A CDMO can help by designing robust quality control batch release tests early in development. Sojka believes biotechs may also be overlooking the importance of a close partnership with your CDMO, including agreeing to note every detail of your manufacturing process.

“There has to be trust, you have to exchange data and you have to believe in each other,” he emphasizes, and he urges biotechs working on cell therapies to approach a CDMO with experience working with cells, even if it is not exactly the cell. type used in their therapy.

According to Sojka, it is also important to have a company that can work with them to source raw materials and distribute their product.