IKM was asked to complete a study and preliminary schematic design to convert an existing storage area into a Good Manufacturing Practice (GMP) stem cell laboratory for the University of Chicago Medical Center. To obtain GMP status as defined by the FDA and CFR Title 21, laboratories must meet strict requirements to follow the protocols that contribute to the manufacture of drugs or human cells.
This project called for a design layout accounting for product flow and human interactions to ensure safety, identity, purity and potency of the manufactured products. The proposed design allowed the investigators to have a space where they could accomplish a variety of processes including the generation of clinical grade peptide-based cancer vaccines, the production of gene modified cellular products, the cryopreservation of these products, and more.
In addition to functionality, Chicago Medical Center sought a design that is both inspirational and conscious of employee well-being. Priority was given to earning the investment of potential grant issuers and creating an environment where investigators can work comfortably and efficiently without getting fatigued.