Gene Therapy Manufacturing

Gene therapies offer an unprecedented potential to treat and cure countless diseases and conditions for which patients have no or limited treatment options. Hundreds of gene therapies are currently in development around the world, being advanced by both early-stage companies and established industry leaders.

Successful development of a gene therapy requires expertise that differs from the production of other biologics such as monoclonal antibodies. Viral vector manufacturing and specialized testing capabilities are unique to this modality and just two areas that can determine the success of a candidate gene therapy. The lack of established process templates, evolving regulatory guidelines, and the need to meet accelerated timelines put additional pressure on gene therapy manufacturers to get it right the first time.

Given the remarkable opportunities and challenges presented by gene therapies, alliances with experienced technology partners or contract development and manufacturing organizations (CDMOs) are essential to ensure successful process development, scale-up, manufacturing, and regulatory compliance.

Reach out to us for more details on our bioprocessing materials and technologies for viral vector production and an expert will respond back to you shortly.