THE OPPORTUNITY

PS&S was retained to provide full design services from concept to construction for a new cGMP BioTech Facility in East Hanover NJ. This facility supports the research for T-Cell Therapy for oncology FDA Phase 2 & 3 clinical trials.

THE CHALLENGE

The new research techniques and equipment needs were still in the selection and development phase, so the space needed to have the ability to adapt to unforeseen process and equipment technology. Existing space to be renovated was a 15 year old research laboratory and air change rates, quality of air grade needed to be updated. Generator systems also needed to be upgraded to support a large number of data needs, cold storage and equipment.

THE PS&S SOLUTION

PS&S prepared material and personnel flow diagrams to ensure an efficient cGMP environment. PS&S worked with international client manufacturing standards which included EU clean room grade classifications with uni-directional flow. The main Cell Suites were designed in a Grade B ISO 6 background with bio-safety cabinets. Design integrated an adjacent ring corridor, Cryo/Freezer storage, Kitting area and entrance & exit airlocks for personnel and materials. Additionally, gowning rooms, quarantine and release storage and QC and Environmental QC laboratories were part of the program. Responsibilities included feasibility, basis of design and construction documentation including full-service, in-house architectural and engineering disciplines.