Forge, TECPR2 Research Foundation strike AAV gene therapy development, manufacturing partnership. Forge will provide process and analytical development, and leverage its proprietary manufacturing efficiency platform. September 29, 2026 Content Marketing Editor Editor's Take: This partnership helps advance a gene therapy program for an ultra-rare condition that primarily affects children. Forge Biologics and the TECPR2 Research Foundation announced a development and manufacturing partnership to advance an adeno-associated virus (AAV) therapy. TECPR2-related disorder is an ultra-rare, genetic, neurodevelopmental and neurodegenerative condition caused by pathogenic variants in the TECPR2 gene. It is classified as a childhood disease, also known as SPG49 or HSAN9. More TECPR2 details. Importantly, TECPR2 has a role in autophagy - a cellular process that degrades or recycles damaged or unnecessary cellular components. The disease can cause certain developmental delays and progressive neurological complications, including respiratory dysfunction, and can be fatal. The investigational AAV gene therapy, then, uses an AAV vector to deliver a functional copy of the TECPR2 gene. This ideally addresses the underlying genetic cause of the disease. How Forge helps. The terms of the partnership charge Forge with providing process development, analytical development and qualification, and manufacturing services. Included therein is the manufacture and release of material for toxicology studies that support the program's continuing advancement. A research team at the University of Texas (UT) Southwestern Medical Center is helping advance the program toward clinical development. Forge is leveraging its proprietary Fuel platform, which helps drive manufacturing efficiencies. Gene therapy possibilities. "This partnership is a shared belief in what gene therapy can make possible," Forge President and CEO John Maslowski said. "For programs like TECPR2, making the most of every manufacturing run is critical. We are honored to bring our manufacturing technology and expertise to a program that is so deeply personal." "For our families, this has never simply been a research program," TECPR2 Research Foundation Co-Founder David Ogman said. "It began with a few children and a commitment to do everything we could to create a path forward... These scientists and partners believe, as we do, that children with ultra-rare diseases deserve the same opportunities as anyone else." Forge Biologics is a member of Ajinomoto Bio-Pharma Services. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Skylark Bio and Forge Biologics announce strategic AAV development and cGMP manufacturing partnership supporting Skylark's clinical development. Skylark Bio is leveraging Forge's AAV FUEL(TM) platform technologies and cGMP manufacturing services to advance its gene therapy for patients with genetic hearing loss CAMBRIDGE, Mass. & COLUMBUS, Ohio-(BUSINESS WIRE)-Skylark Bio ("Skylark"), a clinical-stage biotechnology company developing targeted genetic medicines for hearing loss, and Forge Biologics ("Forge"), a leading manufacturer of gene therapies and member of Ajinomoto Bio-Pharma Services, today announced a strategic AAV development and cGMP manufacturing partnership. "Forge provides the partnership we need to confidently advance our research into clinical development." Share Under the partnership, Forge is providing Skylark with process development, current good manufacturing practice (cGMP) manufacturing, and analytical development services. Skylark is also leveraging Forge's proprietary FUEL(TM) platform technologies, including its HEK293 suspension Ignition Cells(TM) and pEMBR(TM) 2.0 adenovirus helper plasmid. All development and manufacturing activities are being conducted at the Hearth, Forge's 200,000-square-foot gene therapy development and manufacturing facility in Columbus, Ohio. "As we enter the clinic with our lead program, Skylark needs a manufacturing partner who shares our commitment to excellence," said Jodi Cook, Ph.D., President and Chief Executive Officer of Skylark. "Forge provides the partnership we need to confidently advance our research into clinical development. Their end-to-end AAV gene therapy manufacturing capabilities provide exactly the foundation we're looking for, and they've integrated seamlessly with our team to help ensure our therapies are manufactured with the rigor and care that patients deserve." Skylark's lead program, SKY-GJB2, is currently being evaluated in a Phase 1/2 clinical trial for GJB2-related hearing loss, the leading genetic cause of inherited hearing loss worldwide. The investigational AAV gene therapy is designed to deliver a functional copy of the GJB2 gene directly to cells in the inner ear affected by disease-causing mutations, with the potential to address the underlying genetic cause of hearing loss. SKY-GJB2 leverages Skylark's proprietary capsid platform, which is engineered for targeted, low-dose delivery and durable gene expression. "At the heart of our collaboration with Skylark is a shared mission to bring meaningful treatment options to patients," said John Maslowski, President and Chief Executive Officer of Forge. "This partnership reflects our focus on improving how gene therapies are made so more promising medicines can reach those who need them. By combining our platform technologies with manufacturing expertise, we are proud to support Skylark as it advances its gene therapy program through clinical development." About Skylark Bio Skylark Bio is a clinical-stage genetic medicine company developing precision, locally delivered gene therapies for monogenic diseases, with the potential to meaningfully improve patient outcomes and quality of life. The company's lead program, SKY-GJB2, is in a Phase 1/2 first-in-human clinical trial for GJB2-related hearing loss - the leading cause of inherited hearing loss worldwide. A second program targeting SLC26A4-related hearing loss (Pendrin) is advancing through IND-enabling studies. Built on a proprietary capsid engineered for broad transduction, Skylark's platform enables targeted, micro-dose delivery with cell-specific expression control and the potential for durable benefit in non-dividing cells of interest. The company is led by a team with deep expertise in gene therapy and supported by world-class advisors as it expands its platform into additional hearing and CNS indications. For more information, visit Skylarkbio.com and follow Avistatx on LinkedIn. About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge's 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge's end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill-finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com. Contacts. Media Inquiries Skylark Bio: Susan Sharpe Linnden Communications [email protected] Forge Biologics: Media Marina Corleto Associate Director, Marketing & Communications [email protected] Client Development Taleen Barsoumian Senior Vice President, Client Development [email protected] More News From Forge Biologics COLUMBUS, Ohio-( BUSINESS WIRE )-Forge Biologics, ("Forge"), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced that it will deliver seven presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 29th Annual Meeting, taking place May 11-15, 2026, in Boston. The presentations include two technical sessions, co-chairing an oral abstract session, and four scientific posters. "As the gene therapy field enters a crit... SAN FRANCISCO & COLUMBUS, Ohio-( BUSINESS WIRE )-Epicrispr Biotechnologies ("Epicrispr"), a clinical-stage company pioneering gene-modulating therapies, and Forge Biologics ("Forge"), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced a strategic partnership to support the development and manufacturing of EPI-321, Epicrispr's investigational AAV gene therapy for facioscapulohumeral muscular dystrophy (FSHD). Through this collaboration... COLUMBUS, Ohio-( BUSINESS WIRE )-Forge Biologics, ("Forge"), a leading manufacturer of gene therapies and member of the Ajinomoto Bio-Pharma Services group, today announced it has achieved My Green Lab(R) Certification, the global gold standard for laboratory sustainability best practices, across all of its laboratories and manufacturing suites. This milestone reflects a company-wide effort to embed sustainable practices across Forge's operation, reinforcing its commitment to operational excellen...