Seamless Integration in Gene Therapy Process Development

The manufacturing question over adeno-associated viruses (AAV) for gene therapies has moved beyond whether a product can be made to whether it can be made consistently. That’s according to Forge Biologics, a contract manufacturer specializing in AAV production.

According to Sumit Dutta, associate director of upstream process development at Forge Biologics, AAVs maturing as a technology means the industry should become more focused on how best to bring products to market.

“There’s a very heavy focus and investment on late-stage programs, and we need to bring the focus to [process robustness] and thinking about approaches carefully so therapies can get to market, and become available to patients, sooner,” he says.

Forge Biologics works on multiple different AAV programs, allowing them to spot patterns between programs and learn from that, explains Dutta, who argues that they focus on reducing risk and seamless integration between process development for early- and late-stage clinical programs.

“We have early engagement with our key stakeholders so we’re walking in lockstep about what we’re developing, who we’re developing it for and our final target,” he explains. “We ensure the process and technical solutions the development team are coming up with is what is required for the manufacturing process to succeed.”

That can involve identifying critical process parameters and critical quality attributes early and confirming how to study them with high throughput by developing representative scale-down models, he says.

Forge Biologics have also integrated considerations of U.S. Food and Drug Administration (FDA) and other regulatory guidelines throughout their process development, Dutta says.

“Integrating those approaches and ensuring quality and commercialization needs are [also] met along the way is a [key part of] this approach,” he says.

Dutta will be speaking about Forge Biologics’ late-stage development approach at the Bioprocessing Summit in Boston this month.

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