Pilot Scale Production
A Bridge to GMP Production
A Bridge to GMP Scale Production
Bionova provides pilot scale production services for pre-clinical toxicology studies, process scale-up work and other research needs requiring material generated at bioreactor scales of 50L or higher. Bionova’s pilot operation has the flexibility operate with full batch records and QA oversight (both Bionova and client) to provide the documentation and compliance required for GLP studies.
Several different bioreactor options are available including perfusion capabilities at the pilot scale, with a full complement of downstream equipment for chromatography, filtration and formulation. With equipment that mirrors the GMP manufacturing platform, we are able to seamlessly transfer from pilot to clinical/commercial scale.
Typical Pilot-Scale Projects include:
- Toxicology runs to produce GLP material for IND-enabling studies
- Process Scale-up to demonstrate performance prior to GMP clinical supply
- Material generation for R&D and animal studies, further process and analytical development, viral clearance, formulation work, etc.
GMP-like Operation Minus the Clean Room
Bionova’s pilot facility features a range of single-use bioreactor styles (Cytiva XDR 500L, Thermo Fisher SUB 250L, and Pall 200L) to meet our clients’ specific upstream process needs. Perfusion processes can be scaled up with ATF or TFF systems in the production bioreactor or N-1. We also offer Cytiva ÄKTA ready purification systems for downstream operations as well as a full suite of supporting technologies. As with our GMP operation, Bionova’s pilot facility is fully integrated with our cell line development, process development, analytical and quality operations.
