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The Regenerative Medicine Laboratory is a 7100 square foot state-of-the-art clean facility for the manufacturing of clinical-grade cell therapy products. The cGMP (current good manufacturing practice)-compliant laboratory is designed to ensure the highest level of safety and consistency of autologous MSC-NP cells currently in phase II clinical trial testing at the Tisch MSRCNY. The 1000 square foot core of the facility houses two custom built barrier isolators (Biospherix) that function as complete and self-contained production chambers where cells can be manipulated and grown in a sterile and controlled environment. The two isolators with 4 processing modules and 8 full-sized incubators were designed to provide the increased capacity needed to accommodate the scale out of MSC-NP manufacturing during the phase II trial. All manipulation, centrifugation, and incubation steps during MSC-NP manufacturing are performed within the isolator system without a need for cells to ever become exposed to the external room environment, dramatically reducing the probability of insidious microbial contamination.
The laboratory also houses a 182 square foot quality control (QC) laboratory where all in-house quality testing is performed. The QC lab is a fully equipped testing laboratory and includes two real-time PCR instruments for rapid sterility testing and identity testing of final cell products. The environmental monitoring program is supported in the QC lab where two-temperature incubation occurs to evaluate and record values of sampled contact and air monitoring plates from the isolator environment. The Regenerative Medicine Laboratory also houses a cage/locked quarantine/receiving room for materials management, a cryostorage facility, storage/preparation room, freezer/refrigerator room, a manager’s office, and a staff office.
To support the Regenerative Medicine Laboratory’s commitment to quality and product integrity, the quality assurance (QA) department ensures cGMP compliance through a well-developed quality management system including implementation of standard operating procedures, materials management, standardization of manufacturing and QC procedures, asset management and equipment maintenance schedules, document control, environmental monitoring, and a fully comprehensive training program.
Regenerative Medicine Laboratory staff:
Valentina Stefanova, MS – Senior Staff Associate, Quality Control
Bhaumik Shukla, BS – Production Supervisor
Masooda Sultani, BS – Cell Culture Specialist II