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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260616970567/en/
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™ platform technologies, including its HEK293 suspension Ignition Cells™ and pEMBR™ 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 us 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260616970567/en/
Media gallery
