Cell Culture Laboratory
A global leader in contract research providing drug discovery, development and lifecycle management services sought Strang’s council for the expansion of their cGMP assay laboratory located in the Madison area. This facility will help meet the growing needs of clients seeking to validate bioassays for product release and stability testing. Through the expansion, our client’s cell lab will now support a significantly greater volume of bioassay development, validation and testing and provide a broader range of product testing capabilities.
This cell-based lab renovation initially was created to address and respond to requirements for development, validation and testing under established U.S. Pharmacopeial Convention, International Conference on Harmonisation and U.S. Food and Drug Administration cGMP guidelines. The cell lab facility has been expanded to add approximately 6,800 square feet, which will allow for a much broader range and increased volume of testing capabilities. The expansion will add the ability to handle ISO-certified clean-room growth and qualification of cell lines; quarantined segregation of early development projects; increased bioassay capacity and segregation of projects; and BL2/3 isolation for working with viral-based products.