GMP Manufacturing Services
GMP Manufacturing Services
The GMP (Good Manufacturing Practices) Services Core is engaged in synthesis of lead molecules, drug candidates and advanced intermediates on a diverse scale (mg to kg), chemical process development and optimization, scale-up, and analytical method development. The facility is capable of providing small molecule synthesis and protein purification support for pre-clinical drug development to Phase I Clinical Trials. The facility can also support Investigational New Drug (IND) application to the FDA. The facility was inspected by the FDA in 2009.
The facility is directed by Vadim J. Gurvich, Ph.D. and is staffed with Ph.D. and M.S. level scientists with experience in the area of synthetic organic chemistry, chemical process development, analytical chemistry and chemical engineering.
The core facility occupies approximately 1,500 sq. ft. of total space that includes Custom Synthesis Laboratory, Kilogram Scale Chemical Synthesis Laboratory, Active Pharmaceutical Ingredients (API) Kilogram Scale Manufacturing Suite (750 sq ft, located in Molecular and Cellular Therapeutics Facility [MCT] Building), and state-of-the-art Analytical Chemistry Laboratory. The capabilities and equipment include 20 L, 50 L, and 100 L jacketed pilot plant reactors with the temperature range -50 °C to +200 °C, two industrial rotary evaporators Büchi R-220R, MBraun solvent drying system, two large vacuum drying ovens, Labconco Freeze Dry System, large scale Teledyne ISCO Combiflash XL chromatographic system, large scale LyoStar II freeze drying equipment, BioProcess Purification System, AKTA Pilot purification system, WiFi Water Purification System, BTL-433 stability chamber with controlled humidity, and other modern chemical synthesis and purification instrumentation.
Quality Assurance (QA) is provided by the QA Group at the Molecular and Cellular Therapeutics Facility (MCT). The QA includes standard operating procedures (SOP), analytical test methods, batch production records, and training records. Strict document control is implemented to assure full compliance with federal regulations. Our operations are in full compliance with cGMP regulations for investigational new drugs, specifically ICH Q7A, as directed by the FDA.
The QA operations are overseen by Quality Steering Committee that consists of quality professionals from various areas of clinical development. All documentation and QC analytical results for every cGMP batch are reviewed by QA. A Certificate of Analysis is issued for every completed batch. We also work closely with the Office of IND/IDE Assistance Program.
MCT maintains an ISO-based quality system which includes a compliance audit program and oversight by a defined Quality Steering Committee comprised of experienced Regulatory and Quality professionals. During the past five years, three FDA inspections were performed, in August and October 2004, and April 2009.
The Active Pharmaceutical Ingredients (API) Kilogram Scale Manufacturing Suite occupies 2 production suites in the upper west side of the facility, Rooms 125 and 126. The heating and ventilation (HVAC) system provides negative pressure in these areas and the production suites contain fume hoods for synthesis. Room Air Changes exceed 20 air changes per hour and the incoming supply air is filtered via 85% ASHRAE rated filters. Incoming materials are received in the dock area of the lower level, are placed in quarantine pending inspection and released either into the warehouse, Room 53 or into the chemical solvent storage, Room 26. Released materials are staged in the production suites for manufacturing. Finished product is packaged in the manufacturing suites and moved back to dedicated finished product storage in Room 53. MCT maintains an ISO-9001 based quality system, including a Quality Manual and Drug Master File and provides all quality related services, including documentation change control, purchasing, ordering, receiving and inspection, compliance audit activities, equipment qualification, maintenance and calibration, as well as finance and project management.