Capabilities

The UMBI GMP Training and Biomanufacturing Facility has the capability to produce multiple biological products under cGMP regulations for Phase I / II clinical trials and to train in cGMP operations.

- Bioreactors up to 100 liter scale are available for cell culture and bacterial or yeast fermentation.

- State of the Art Tangential-Flow filtration harvesting, clarification and concentration devices.

- Products may be protein, nucleic acid, cellular or nanoparticles.

- Products may be viral, to Biosafety level 2 (BSL-2), or non-viral.

- The clean rooms are divided into two separate production trains so that multiple products may be produced simultaneously.

- The facility can also provide process development services for either manufacturing or assay development.

- As a Training Center, the GMP Training and Biomanufacturing Program can provide lecture only or combined lecture/lab training.

-The program has expertise in cGMP compliance and technical aspects of cGMP operation.