Viralgen Joins Orphan Therapeutics Accelerator Clinical Development Network as a Manufacturing Partner to Advance Rare Disease Therapies

Viralgen brings strong AAV gene therapy manufacturing capabilities to growing group of partners supporting new model for developing and commercializing orphan drugs

BOSTON, and SAN SEBASTIAN, Spain, May 14, 2025 /PRNewswire/ -- Orphan Therapeutics Accelerator (OTXL), a non-profit biotech dedicated to advancing therapies for ultra-rare conditions, today announced that Viralgen has become a Contract Development and Manufacturing Organization partner within OTXL's Orphan ClinDevNet network. As a network partner, Viralgen will have the opportunity to provide manufacturing strategy and execution for adeno-associated virus (AAV) gene therapy programs that are being developed under OTXL's distinct model from clinical development through commercialization.

OTXL's Orphan ClinDevNet brings together specialized partners with a commitment to overcoming key barriers to successful development and commercial access to ultra-rare disease treatments, including the cost and pace of late-stage clinical trials and difficulties in continuity and scaling of manufacturing for commercial access. Viralgen's expertise in AAV manufacturing and critical related strengths in chemistry, manufacturing and controls (CMC) can help to ensure that more AAV gene therapies reach patients.

"Dozens of promising gene therapy programs for ultra-rare diseases have been shelved in recent years – often because of the investment and time required to complete their development," said Craig Martin, CEO of Orphan Therapeutics Accelerator. "Viralgen brings unique AAV gene therapy manufacturing capabilities to our network, as well as a long history of working with non-profits and biotechs in support of rare disease innovation."

Based in San Sebastián, Spain, Viralgen is a Contract Development and Manufacturing Organization dedicated to AAV gene therapy production across clinical and commercial stages. As part of ClinDevNet, Viralgen will collaborate closely with OTXL and other members of ClinDevNet to support gene therapies from investigational new drug (IND) applications through commercial readiness.

"We're proud to support OTXL's mission and contribute to AAV gene therapy manufacturing efforts across the network," said Jimmy Vanhove, CEO of Viralgen. "Each therapy we can manufacture is a chance to change the life of someone living with a rare disease - inspiring us to push forward with urgency and care".

About Orphan Therapeutics Accelerator (OTXL)

The Orphan Therapeutics Accelerator (OTXL) is a patient-centered non-profit biotech focused on obtaining and reinitiating development of promising "shelved" clinical-stage treatments for ultra-rare conditions and providing a scalable and sustainable commercialization path to get these treatments to patients. OTXL leverages its non-profit status, success-based agreements and incentives to obtain rights to shelved programs and complete development at deferred or lower cost via a network of affiliated CDMOs, CROs and other partners. When a program is approved and generates revenue, net proceeds are used to repay and reward contributing partners, companies, and institutions, with a portion returned to the Orphan Therapeutics Accelerator to fund additional programs. Our team is deeply familiar with challenges faced in developing and commercializing treatments for rare conditions and committed to overcoming them. 

For more information, please visit orphantxl.com.

About Viralgen

Viralgen, founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, is a contract development and manufacturing organization specializing in the large-scale production of current good manufacturing practice (cGMP) adeno-associated virus (AAV) for cell and gene therapies. Utilizing the Pro10™ suspension manufacturing platform, Viralgen achieves high titers for all AAV serotypes, enhancing clinical development and commercialization efficiency. Located in San Sebastian, Spain, its state-of-the-art facility features three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA. The company also offers advanced services for transitioning from clinical to commercial manufacturing and has recently expanded its development services to include construct and process optimization.

For more information, please visit viralgen.com.

SOURCE Viralgen