Sign in
Welcome! Log into your account
Forgot your password? Get helpPrivacy PolicyPassword recovery
Recover your password
A password will be e-mailed to you.
GEN – Genetic Engineering and Biotechnology NewsHomeTopicsBioprocessingSeamless Integration in Gene Therapy Process Development
Upstream process development [Forge Biologics]
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 theBioprocessing Summitin Boston this month.
InsightsAdeno-associated virusContract manufacturingGene therapy (Genetic engineering)United States Food and Drug AdministrationUpstream processingForge BiologicsAlso of Interest
Top 10 Contract Development and Manufacturing Organizations 202610 CDMO Up & Comers 2026AI Accelerates Biomanufacturing from Discovery to TranslationPurifying Complex Therapeutics Requires Fresh ApproachesDesign for Commercial Scale from Day OneManaging Misbehaving mAbs with Advanced Purification StrategiesRelated Media
EnablingIn VivoLentiviral Therapies: Manufacturing Strategies to Improve Purity, Scalability, and Clinical ReadinessBye, Bye, Baltimore:GEN’s Takeaways from ASGCTAddressing Barriers in Gene TherapyBIO CEO Rachel King Outlines Industry's Challenges on "Close to the Edge"Materials Sourcing: Precautions and Improvements for Cell and Gene TherapiesShehnaaz Suliman, MD, MPhil, Discusses Targeted Respiratory Therapies on "Close to the Edge"Top 5ResourcesRecommended For YouPodcast
Touching Base
Touching Base is the dynamic podcast series from the editors ofGEN. Each episode features a rotating case of senior editors—including John Sterling, Kevin Davies, Julianna LeMieux, Alex Phillippidis, Uduak Thomas, Corinna Singleman, and Fay Lin—who delve into emerging stories, exchange ideas, and debate the latest trends in biotech. Additionally, they talk to some of the leading voices in the industry about what's now and next.Start listening today!
Stay up to date with the lasted episodes of Touching Base bysubscribing to theGENPodcast Newsletter
Copyright © 2026 Sage Publications or its affiliates, licensors, or contributors. All rights reserved, including those for text and data mining and training of large language models, artificial intelligence technologies, or similar technologies.
MORE STORIES
