cGMP production facility
ISO Certified (ISO 14644-1:2015) and containing 8 dedicated cleanroom suites.
Commissioned in 2021, our cGMP production facility is designed to provide stringent environmental controls and material segregation necessary for both INDReady® and cGMP plasmid DNA.
The ISO Certified cleanroom facility is separated from our main facility by a primary airlock, with secondary airlocks protecting eight different production suites. Every individual suite includes a fermentation and lysis lab as well as a purification lab.
At a glance
HVAC and environmental controls
- Primary and secondary airlocks keep the facility under a state of control through physical segregation.
- HEPA filtration removes 99.97% of particles >0.3um from the air, allowing for the addition of “clean” and controlled air throughout.
- Differential airflow hierarchy ensures the entire cleanroom and each production suite maintain high pressure, creating pressure gradients to reduce the likelihood of contamination.
- The BAS (Building Automation System) provides 24/7 minute-by-minute monitoring of air pressure differentiation.
- BAS information is securely stored and maintained for historical use to support collaborator filing requirements.
Additional quality controls
Daily equipment and temperature monitoring
Critical materials are stored in electronically monitored refrigerators and freezers, with instant quality notification of any issues. All equipment has a designated backup in the event of an equipment malfunction.
RO/DI water filtration
The cleanroom facility’s reverse osmosis deionization system supplies deionized water with a resistivity of ≥17 M-Ohms for solution and media preparation, as well as for washing and rinsing processing components and glassware.
Suite and equipment cleaning
Each production suite is cleaned before and after each manufacturing campaign with a validated cleaning procedure and documented on batch record documentation for the plasmid production.