Aseptic Processing Laboratory
Facility Description
The Aseptic Processing Laboratory is an approximately 10,000 ft2, controlled access GMP compliant space on the 11th floor of the new research building known as Location S on the CCHMC campus. The facility includes suites designated for Vector Production, Cell Manipulations, Material Repackaging, and general support areas. The facility consists of non-classified, ISO Class 7 and ISO Class 8 areas. Each production room is designed to provide a contained manufacturing area suitable for aseptic manufacture of CGMP products using an ISO Class 5 biological safety cabinet (BSC).
All areas of the production facility are designed to a high standard of cleanliness. The design ensures orderly flow of raw materials, process, and personnel. During clinical production, personnel entering the cleanroom are required to wear personal protective equipment, including sterile coveralls, hair covers, shoe covers and gloves. All open-container processing is performed inside a BSC in the tissue culture labs. The air inside the cleanroom is HEPA-filtered, and manufacturing conditions have been further optimized by a system of differential air pressures between individual rooms. In addition, pre-production corridors, production suites and BSCs have been equipped with a 24/7 central particle monitoring system. All rooms and surfaces are regularly maintained and monitored for viable and non-viable contamination. Critical laboratory equipment is validated prior to use and is connected to a validated building monitoring and alarm system.
Vector Production Suite
The Vector Production suite will be used to provide a controlled environment suitable for the aseptic manufacture of early phase GMP products including Retroviral, Adeno-associated Viral Vectors (AAV), Lentiviral vectors, Master Cell Banks, Master Viral Banks and other vector systems not to exceed Biosafety Level 2 (BL2) requirements. The Vector Production Suite consists of three production room cores and ancillary support rooms.
Cell Manipulations Suite
The Cell Manipulations suite will provide a contained manufacturing area suitable for aseptic manufacture of Somatic Cellular Therapy products produced according to GMP requirements in support of clinical protocols. The Cell Manipulations Suite consists of four production rooms and ancillary support rooms.
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.
Vector Production Segregated Suite
The suite consists of a single production room designed to provide a segregated manufacturing area suitable for aseptic manufacture GMP products including Retroviral, AAV, Lentiviral vectors, Master Cell Banks, and Master Viral Banks and other vectors system requiring increased segregation not to exceed BSL2 requirements. A single product would be manufactured in this suite at a given time.
Materials Storage Rooms
The materials storage rooms will be used to store raw materials, intermediate materials, and final products at their requisite storage temperature. These storage rooms will contain refrigerators, freezers, and racks for ambient storage. All materials will be segregated based on status: quarantined, released, or rejected. The materials storage rooms are non-classified areas, but are access controlled.
QC Testing Lab
The testing laboratory is a fully equipped non-cleanroom BL2 research laboratory designed to support the Aseptic Processing Lab. The QC lab is primarily used to prepare and process microbiological samples and other materials that cannot be manipulated in the cleanroom. The lab contains a microbiological safety cabinet, a combination refrigerator/freezer, and microbiological incubators.
For further information regarding the Aseptic Processing Laboratory, please contact, Dr. Han van der Loo at 513-803-1066, Diana Nordling at 513-803-1063 or William Swaney at 513-803-1067. For additional information about the Division of Experimental Hematology and Cancer Biology, please contact Dr. Yi Zheng at 513-636-0364. The Division of Experimental Hematology and Cancer Biology Translational Cores can be found on the 11th floor of Location S (Research Foundation Building) Suite 400.
