A global contract developer says it is among the first to offer a standardized approach to manufacturing adeno-associated viruses (AAVs) and lentiviruses (LVVs) for advanced therapies. AGC Biologics joins fewer than a handful of companies to offer contract development and manufacturing organizations (CDMOs) aimed at the emerging gene therapy market.

The standardized approach for AAV and LVV, presented at the Terrapinn conference on Advanced Therapies by Martina Brunati, PhD, upstream vector development manager at AGC Bio’s Milan site, was launched last year.

AAV and LVV platforms cover the entire vector manufacturing process, from transfection to purification, as well as suspension and adherent processes.

“The most important point is that, as a CDMO, we need to be flexible to deal with requests from clients,” Brunati explains. “They might need lentivirus or AAV, they operate at different scales, and are in different phases of clinical trials.”

Adherent or suspension processes

AGC Bio offers adherent or suspension processes depending on client preferences, including what the client already uses. Suspension processes have the benefit of being scalable up to 1,000 L for lentivirus, and 2,000 L for AAV, notes Brunati. However, some clients will be working with adherent cells already in which case the processes are scalable to 750 L for both vector types.

Brunati also presented the challenges that AGC Bio is working to overcome. One is removing the final sterilization step for lentivirus production, as the diameter of the filters is similar to the viruses, leading to product loss.

“We’re moving to close the process to remove that sterilization step, but it’s a hard task because there are no resins [currently] available with a declaration of sterility,” she says.

Her team is also working to improve the polishing step of AAV manufacturing where empty viral capsids are separated from ones containing the vector using anionic exchange chromatography, according to Brunati.

Finally, Brunati’s talk highlighted the importance of scaling down processes to test new steps or making alterations to existing ones.

“If you change something, these processes needed to be tested at a smaller scale before being introduced into a large-scale process,” she pointed out.

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