The UR GMP facility is designed to be a multi-use, clean room facility, with high flexibility and versatility, for the production of clinical grade therapeutics. The facility is contains 3 production suites, an analytical testing laboratory, storage and office space (see layout below).
One production area will be utilized for the preparation of tissue derived neural stem cells, including both fetal and adult tissue derived cells. The second suite will be used to produce tissue derived autologous mesenchymal stem cells and embryonic stem cells. A third production suite will initially be used for support activities and for overflow of additional production events including reagent preparation, sterile cell sorting and monoclonal antibody (Mab) production. Mabs will be produced under cGMP conditions and used as reagents for the purification of neural stem cells. The integrated analytical testing laboratory will provide a support area for in-process and product release testing as well as for the incubation of viable samples for environmental monitoring.
This multi-use facility is designed to minimize the potential for contamination and/or cross-contamination of manufactured products. Independent air handling systems and finishes for walls, floors, and ceilings are suitable for cGMP production of clinical trial materials.
Entry into the facility is through a negative pressure Gowning Room equipped with a pass-through and LN2 transfer port. The subsequent Intermediate, Class 100,000 (ISO Class 8), Entry Room contains LN2, -80ºC and -20ºC freezer space, refrigerator space, metro storage shelving, a work desk, and a sink.
From the Intermediate Entry Room there is access to 3 separate manufacturing laboratories, designated MFG 1, MFG 2, and MFG 3. Each manufacturing area has its own HEPA filtered HVAC unit operating independently providing Class 10,000 (ISO Class 7) air. MFG 1 is equipped with bio-safety cabinets, a bio-safety cabinet / cell sorter, dual chamber incubators, a WAVE bioreactor, downstream Mab purification system, pass-throughs and stainless work tables. MFG 2 and MFG 3 will each be equipped with bio-safety cabinets, dual chamber incubators, a CliniMACs cell separation system, pass-throughs and stainless work tables.
Exit from the facility is through a Class 100,000 Intermediate Exit Room equipped with LN2, -80ºC and -20ºC freezer space, refrigerator space, metro storage, shelving, a work desk, a sink and through a negative pressure De-gowning Room with a LN2 transfer port.