SAN CARLOS, CA / ACCESS Newswire / May 11, 2026 / Form Bio, a leader in AI-powered genetic medicine development and genome engineering, today announced the launch of FormManufacturing™, a new platform designed to predict, optimize, and monitor manufacturability for cell & gene therapies (CGT), from initial construct design through commercial scale-up.
Debuting with an AAV-focused offering, FormManufacturing integrates AI-driven design optimization with deep genomic characterization to address one of the industry’s most critical challenges: ensuring that the therapy designed is the therapy consistently manufactured.
Manufacturing remains the primary bottleneck in CGT. Seventy-four percent of FDA rejections are triggered by quality or manufacturing issues. Subtle genomic changes during cell line expansion, viral integration, and scale-up can alter product potency and safety, often without detection until late-stage development or regulatory review. At the same time, regulators increasingly expect quantitative, data-driven evidence of lot-to-lot comparability to support IND and BLA submissions.
FormManufacturing addresses this gap upstream. The platform combines:
AI-driven design optimization (FormSightAI™): Screens thousands of constructs in silico to identify manufacturing risks, such as partial capsids, host contaminants, CpG islands, all before they reach the lab.
Genomic quality and comparability analytics (FormBatchQC™): Quantifies genome integrity, detects impurities, and provides defensible regulatory evidence of lot-to-lot consistency from tech transfer to commercialization.
Together, these capabilities enable developers to design for manufacturability from day one and track product integrity through scale-up.
Across customer programs, Form Bio has demonstrated:
8x improvement in genome integrity
2-3x increase in manufacturing yield
5x improvement in controllable expression
“At Form Bio, we’re redefining how biopharma developers ensure quality and reduce risk across the development and manufacturing lifecycle of genetic medicine,” said Michelle Chen, Ph.D., President and CEO at Form Bio. “By combining payload characterization, AI-driven design optimization, and manufacturing comparability analytics, we deliver the molecular intelligence needed to scale high-quality CGT therapies from discovery through commercial manufacturing.”
“Traditional process improvements have reached their limits. The next frontier is biological optimization, designing therapeutics for manufacturability from day one,” said Behzad Mahdavi, Ph.D, MBA, Founder of Innov2Gro and former senior executive at Lonza, Catalent, and Ginkgo Bioworks. “This is how we unlock scalable production, improve product quality, and accelerate time to market. Form Bio brings the molecular and computational rigor needed to make that vision a reality.”
Form Bio at ASGCT 2026
Form Bio will showcase FormManufacturing at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, May 11-15 in Boston. Attendees can visit Booth #732 to learn more about its AI-powered approach to design and manufacturing. The company will also highlight its scientific rigor through high-profile collaborations, presented in the following posters and talks:
For more information on the FormManufacturing platform or to schedule a meeting at ASGCT, please contact [email protected].
About Form Bio
Form Bio is a leader in developing AI-powered solutions for genetic medicine and genome engineering. Since spinning out from Colossal Biosciences in 2022, the company has become a trusted innovation partner to cell and gene therapy developers and beyond. Form Bio’s advanced in silico technology and computational platforms deliver deep insights into genome integrity, optimized payload design, and other critical factors-enabling safer, more efficacious, and more manufacturable therapeutics. By reducing risk, shortening timelines, and optimizing outcomes, Form Bio helps drug developers accelerate the path from discovery to the clinic. For more information, visit http://www.formbio.com or follow us on LinkedIn.
Media Contact:
Angela Anderson
[email protected]
http://www.formbio.com
SOURCE: Form Bio
