Forge Biologics Receives Qualified Person Declaration to Manufacture AAV Gene Therapies

Forge Biologics, a manufacturer of genetic medicines, announced that its manufacturing facility has successfully completed the audits necessary and received QP declaration for its gene therapy manufacturing facility, thereby fulfilling the EU Good Manufacturing Practices (GMP) requirement to manufacture investigational medicinal products and allowing Forge to support European-based clinical trials.

“QP declaration enhances Forge’s position as a leading global AAV manufacturer able to support clients with the production of high-quality therapeutic products destined for European distribution and helping them to reach patients needing treatments as quickly as possible,” said Christopher Shilling, senior vice president of regulatory affairs and quality at Forge.

According to the company, a European QP has completed a comprehensive and in-depth audit focused on the quality management systems (QMS) and platform AAV manufacturing process at Forge’s manufacturing facility in Columbus, OH, and determined that its facilities, raw materials, suppliers, procedures, and quality systems meet EU GMP requirements. In the EU, a QP is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU or imported into the EU.

In addition, having fulfilled Europe’s GMP requirements, Forge has reached another key regulatory milestone, expanding its CDMO services to support clients in the U.S. and Europe. Forge clients can rely on the Company’s QP audit as one less hurdle they need to overcome when their AAV gene therapy products are being manufactured for clinical trials and on the path to commercialization in European countries. The QP declaration was received in support of Forge’s internal FBX-101 clinical gene therapy program for the treatment of patients with Krabbe disease.

“The declaration is a significant milestone that demonstrates Forge’s capability to pass the EU QP audit and obtain QP declaration, which will enable us to manufacture products for gene therapy programs to treat patients in the U.S. and Europe,” said Meghan Leonard, vice president of Quality Management at Forge.

The QP declaration adds to Forge’s capabilities and makes the Company among one of the few U.S. AAV CDMO’s able to support clients intending to export gene therapy products for clinical programs in Europe.