Capabilities

The UMBI GMP Training and Biomanufacturing Program has the capabilities 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 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 Program can provide lecture only or combined lecture-lab training.

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

·    The facility has been designed to be flexible and adaptable to accommodate a wide variety of projects. 

Potential clients are encouraged to contact the facility to discuss options that are available to satisfy their unique needs.