The road to the formation of Andelyn Biosciences started more than 15 years ago on the third floor of a research building at Nationwide Children’s Hospital.
At that time, GMP facilities were unheard of at children’s hospitals and gene therapy research was a rarity.
Nationwide Children’s physician-scientists collaborated with hospital and research institute leadership to create a small GMP facility to produce viral vectors for gene therapy clinical trials. Having this resource accelerated the hospital’s gene therapy program and helped bring some of the brightest minds to Nationwide Children’s.
The talent and tenacity of the researchers focused on gene therapies have paid off with the first FDA-approved systemic gene therapy for spinal muscular atrophy (SMA). Many more gene therapies – and now cell-based therapies — have progressed into clinical trials.
The Abigail Wexner Research Institute at Nationwide Children’s opened a larger cGMP Clinical Manufacturing Faculty (CMF) in 2017, which will initially house Andelyn Biosciences.
The current facility consists of
- Clean Room Suite with ISO Class 5/7/8 spaces
- Quality Control Laboratory
- Research Production Viral Vector Core (VVC) Laboratory
- Process Development Laboratory
The clean room space is comprised of five production suites and has the capability to produce up to four different viral vector products simultaneously. The clean room space also includes dedicated areas for solution preparation and cell culture.
Adeno-associated virus (AAV) gene therapy vectors are currently manufactured to ensure product safety, identity, purity and strength. The Quality Assurance Unit has facilitated numerous audits including audits to endorse regulatory requirements for Health Canada, the European Medicines Agency, and others.
The Evolution of Andelyn
2006: NCH builds a vector manufacturing core facility
2011: Release of first gene therapy product for clinical use
2017: Current clinical manufacturing facility opens
2019: Expansion of offering to include research grade plasmids
2020: Addition of a 200L bioreactor to further enhance manufacturing capabilities.
2020: Expanding to phase III manufacturing capabilities
2020: Creation of Andelyn as standalone entity
2021: Begin offering clinical grade plasmids
2023: Completion of a new state-of-the-art cGMP manufacturing facility to fulfill client demand and become a full, turn-key gene therapy CDMO from conceptual development through commercial production
2023: Commercial grade plasmids capabilities