Andelyn Corporate Center
The Andelyn Corporate Center (ACC) is our corporate headquarters where we manufacture clinical and commercial gene therapies.
Facility and Capabilities
The Andelyn Corporate Center (ACC) is our 180,000-square-foot corporate headquarters in Columbus, OH, boasting reliable clinical and commercial gene therapy manufacturing. The ACC houses 16 cGMP modular manufacturing suites for upstream and downstream processing, solution preparation, and fill-finish, as well as our quality control labs, quality assurance, supply chain and warehousing, and corporate headquarters space.
Our capabilities at the ACC include TOX, GMP, and commercial manufacturing with a multitude of platforms including single-use suspension stirred-tank bioreactors at 50L, 200L, 500L, and 2,000L, and HYPERStack® Vessels for adherent production. For the suspension bioreactors we have Cytiva Allegro STR Systems and Sartorius Biostat STR® Systems, yet remain flexible for implementing other brands and platforms for tech transfer of established processes into Andelyn.
The overall design of the ACC facility supports completely independent operations in each manufacturing cleanroom. This capability is achieved via the following key attributes:
- The air handlers for our upstream manufacturing cleanrooms and downstream purification cleanrooms are designed with single pass air. Air is taken from the outside, conditioned and filtered, then sent into the cleanrooms through ceiling mounted, terminal HEPA filters. Air is exhausted from these rooms via low wall returns and through our exhausting biosafety cabinets to the outside of the building. No air from these cleanrooms is returned to the rooms.
- The airlocks are designed as “pressure sinks” where the pressure inside of the airlock is set lower than the adjacent spaces. This pressurization scheme is done as a containment strategy so that there is no chance to cross-contaminate other manufacturing rooms. This feature also provides for cleanliness with the manufacturing room set at the highest pressure relative to the adjacent spaces.
- All flows (personnel, materials, and waste) are unidirectional.