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GMP Facility - Aseptic Processing Laboratory
The 10,000 ft2 Aseptic Processing Laboratory cleanrooms (ISO Class 7 and ISO Class 8) include areas designated for Vector Production, Cell Manipulation, and general support. Each production room is designed to provide a contained manufacturing area suitable for aseptic manufacture of cGMP or GTP products using an ISO Class 5 biological safety cabinet (BSC).
All areas of the production facility are designed and maintained to a high standard of cleanliness. The design ensures orderly flow of raw materials, processes, and personnel. During clinical production, personnel entering the cleanroom wear personal protective equipment, including sterile coveralls, hoods, booties, sleeves, masks, eye covering, and gloves. All open-container processing is performed inside a BSC.
The air inside the cleanroom is HEPA-filtered and environmental conditions have been optimized by a system of differential air pressures between individual rooms. These cleanrooms are serviced by independent HVAC system backed by redundant fans, UPS and emergency power generators. Pre-production corridors, production suites and BSCs have been equipped with a state-of-the-art 24/7 automated particle monitoring system. All rooms and surfaces are maintained and monitored for viable and non-viable particulates and the facility is regularly re-certified.
The cleanroom facility, critical controls and critical laboratory equipment are validated and connected to a building monitoring and alarm system validated according to 21 CFR 11. All GMP laboratories are access controlled.
Vector Production Facility
The Vector Production Facility is used for the aseptic manufacture of early-phase GMP products including Retroviral and Lentivirus vectors. The facility consists of three production rooms for concurrent production. The lab is equipped with scaleable Tangential Flow Filtration (TFF) and Liquid Chromatography (LC) systems.
Cell Manipulations Laboratory
The Cell Manipulations Laboratory is used for the processing of more-than-minimaly manipulated Somatic Cellular Therapy products made according to cGMP and GTP requirements. The laboratory currently consists of four processing areas. The lab currently uses a CliniMACS® and SePax® for cell isolation and provides cell expansion, processing and transduction in support of gene therapy trials.
Material Storage Rooms
The material storage rooms are used to store raw materials, intermediate materials, and final products at their requisite storage temperature. The storage rooms contain refrigerators, -12°C, -20°C, and -80°C freezers, gas-phase liquid nitrogen freezers, and storage racks for ambient storage. All materials are segregated by release status (quarantined, released, or rejected) and lot number. The materials storage areas are access controlled, equipment is centrally alarmed, and temperatures are continually recorded..
Quality Control Laboratory
The Quality Control laboratory is a fully equipped non-cleanroom BL2 research laboratory designed to support the Aseptic Processing Lab. The laboratory is used to prepare and process microbiological samples including environmental monitoring samples and other testing in compliance with the United States Pharmacopeia (USP) requirements.