Gaining an early understanding of every step in your manufacturing and analytical processes is essential to bringing gene and cell therapies successfully to market. That’s according to Melissa van Pel, PhD, head of cell therapy at NecstGen, who spoke exclusively to GEN about a talk she presented at the Terrapinn Advanced Therapies Congress held earlier this year.
GEN: What were the key messages of your talk?
van Pel: The takeaway message is that when translating your process into a GMP-compliant manufacturing protocol, it’s important to understand all the critical steps and have the right analytical testing strategies to control them.
GEN: I understand Nectsgen is a CDMO owned by an academic hospital. Can you tell me about your customers and their challenges?
van Pel: We talk to both early- and late-stage advanced therapy developers. Some already have a process and testing in place, and we simply do a technology transfer. Some early-stage developers, however, aren’t necessarily aware of the GMP requirements for clinical production. They might have too many open handling stages or their analytical toolkit may not generate reproducible data.
Sometimes, if they come from an academic background, their testing strategies are too comprehensive for clinical manufacturing. For example, they might run 10 surface marker tests on T cells for a CAR-T therapy.
There’s nothing wrong with carrying out detailed research to understand your product, but it should be balanced with the time needed to get to the market and to patients.
GEN: As a CDMO, how do you help these companies?
van Pel: It’s best that companies talk to us early so we can give them the best advice possible. For example, if they are testing too many surface markers, we can see which ones are necessary for monitoring their production process.
On occasion, there’s a lot of room for automation, such as incorporating a bioreactor or automated quality control testing. Automation has many advantages, such as providing a closed process, which reduces operator handling and the chance of contamination.
However, automation should always be phase appropriate. Sometimes our customers have a process that is better to do in a large clean room, or the therapy might be in early clinical trials and it’s too expensive to automate at that stage.
