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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, Material Repackaging, 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) or isolator cabinet.
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 and gloves. All open-container processing is performed inside a BSC or isolator.
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 which meets GMP requirements for the EU. All rooms and surfaces are maintained and monitored for viable and non-viable particulates and the facility is re-certified on a semi-annual basis.
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.
The new cleanroom facility was opened in 2009 to specifically meet the demanding needs of the scientific community. In Jul 2007 we presented the cleanroom design and process flow to the FDA/CBER. Based on this reveiw, the facility's design meets or exceeds guidelines for clinical research purposes. Validation of the new facility was completed in Jul 2009 and the clinical production was intiated in Aug 2009.
Vector Production Facility
The Vector Production Facility is used for the aseptic manufacture of early-phase GMP products including, but not limited to, Retroviral, Adeno-associated Virus (AAV) , Adenovirus (Ad) and Lentivirus vectors, Master Cell Banks, Master Viral Banks and other vector systems at Biosafety Level 2 (BL2). The facility consists of three production rooms for concurrent production. The lab is equipped with scaleable single-use Wave Bioreactors, Tangential Flow Filtration (TFF) and Liquid Chromatography (LC) systems. The LC systems include an AKTAready for closed system clinical manufacturing and AKTAavant for development and scale-up.
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 one processing area with the capaciltiy to expand to four additional processing rooms. One single product would be processed in this suite at a given time. The lab currently uses a CliniMACS® for cell isolation and provides cell expansion, processing and transduction in support of gene therapy trials.
Materials Repackaging Suite
The Materials Repackaging Suite provides a cleanroom environment suitable for aseptic repackaging of sterile raw materials or sterile filtration of bulk raw materials excluding recombinant DNA or patient samples. Cytokines, cell growth media, and Retronectin® are examples of products or raw materials for which this may be applicable.
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 recorded using charts and electronic data loggers..
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.