Reducing Risk For Commercial Manufacturing Of Cell And Gene Therapies

By Cyrill Kellerhals, Head of Manufacturing, Andelyn Biosciences

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk. Serving as many patients as possible as quickly and resourcefully as possible requires particular focus on three key areas: Manufacturing, Quality Control, and Process Development.

Andelyn Biosciences, a gene therapy CDMO spun out of Nationwide Children’s Hospital, has amassed the necessary expertise to support complex biologics in achieving late-stage manufacturing readiness by working across these key areas to establish interconnected, optimized manufacturing processes. With three facilities in the Columbus, Ohio area – a plasmid facility on the campus of Nationwide Children’s, a new GMP manufacturing facility, and a development center in nearby Dublin, Ohio – Andelyn has the capacity and expertise to provide end-to-end development and manufacturing services.

Andelyn’s long and pioneering history with gene therapy modalities and adeno-associated virus (AAV) therapies – researchers at Nationwide developed Zolgensma, the first systemic gene therapy approved by the FDA – enables it to leverage its legacy of expertise for accelerated and agile development and scale-up.