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Your First Application to the GCRC
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Copy-Paste: Sample Wording — Gene and Cell Therapy Core Laboratory
When you prepare applications and publications related to research conducted at the GCRC,
you are welcome to use the following sample wording (amended
appropriately). Additional information may be found on our Copy-Paste
Wording page.
For IND applications and other documents that require extensive documentation on the GCTC,
contact the GCTC Lab Manager.
Our productivity is measured in part by the number of publications arising from studies that
use GCRC resources. If your study is supported by the GCRC, we rely on you to
cite our grant in your publications. Don't forget to send
us a reprint too! (campus mailBox 356178). Thank you!
The GCTC Lab is located on the UW GCRC, across the hall from patient rooms, facilitating the
transfer of patient samples between the clinic and the laboratory. It is the only laboratory
equipped to enable manufacture of clinical-grade gene vectors and cells at an educational
institution in the northwestern United States.
The laboratory is composed of four critical environment suites, accessible only to authorized,
trained personnel using an electronic security card system. The 2200 square foot cleanroom
facility contains four cell processing suites and adjacent storage, gowning, cryopreservation,
and support rooms. Two suites meet biosafety level (BL) 3 standards, enabling trained
technicians to handle highly infectious samples, while the other suites meet BL2 standards
to allow for the handling of conventional virus vectors and blood products. The production
facility was constructed according to specification set by CFR, Title 21, Sections 210 and
211. Prior to beginning production, validation of the clean room, utilities and equipment
was conducted in accordance with NEBB standard procedures, IES standards, and Federal Standard
209E.
Prevention of Cross-Contamination
Consistent with current Good Manufacturing Practices (cGMP) guidelines on preventing
cross-contamination of products, each suite is outfitted with dedicated cell culture
equipment, including biosafety cabinets, refrigerator/freezers, incubators, refrigerated
centrifuges and microscopes. A qualification program has been established for all cells,
reagents, and equipment used in the manufacture of the cell therapy product. All consumables,
reagents, and equipment used in the manufacturing process are dedicated to only one research
subject's lot campaign at a time. Product identity is assured by segregation of each research
subject lot into a separate Cleanroom laboratory. All reagents used in the production of cell
product possess a unique part number and are assigned a receiving number specific to
manufacturer's lot and date of receipt. Both identifiers are used for tracking purposes
throughout production. A certificate of analysis, obtained for all purchased reagents from
the manufacturer, is used to qualify the product. Critical reagents, such as Interleukin-2,
DMSO, and human serum albumin, are USP grade and obtained from the University of Washington
Pharmacy . All products are received into the GCTC facility via quarantine and release
procedure monitored by the Quality Control/Quality Assurance department.
Cross-contamination between suites is further minimized by unidirectional traffic flow dictated
by architectural design and standard operating procedures. Suites undergo thorough cleaning
between manufacturing campaigns. The suites exit into the waste management area, which
includes an autoclave for decontaminating biohazardous waste. To ensure stable ISO Class 7
conditions, there are fully redundant HEPA filtered supply and exhaust air handling systems
in the critical environment and adjoining support rooms, as well as an air pressure cascade
throughout the facility. Each laboratory is designed to meet ISO class 7 or better
environmental criteria. The GCTC facility is routinely monitored for viable and nonviable
air particulate counts and surface microbial contamination. The storage room contains
refrigerators and freezers for study supplies and products (for quarantine and release)
as well as liquid nitrogen storage units for cryopreservation of patient cell banks.
Quality Assurance
The GCTC laboratory provides a full time Quality Assurance officer with over twenty years of
experience to ensure all aspects of clinical production follow strict adherence to cGMP. All
procedures performed in the GCTC Lab are conducted using cGMP guidelines outlined in the Code
of Federal Regulations 21, parts 210 and 211 with Quality Control and Quality Assurance
oversight. All staff are trained in cGMP and conduct procedures according to protocol and
Standard Operating Procedures developed for use of the facility and equipment as well as
the production of cell therapy products.
Calibration Program
A Calibration Program was designed to ensure that utilities, equipment and instrumentation used
in support of clinical production operations and product control are calibrated prior to use,
that the due date has not been exceeded and to delineate the responsibilities for oversight and
implementation. Unless otherwise specified, each piece of equipment or instrumentation is
recalibrated on an annual basis, minimally. The production facility contacts the services
of independent calibration firms to perform calibrations. Calibrations are performed
according to written protocol using calibrated reference equipment that is NIST traceable
or other acceptable standards.
Preventative Maintenance Program
Equipment used in the facility is placed on a preventative maintenance program. The extent of
the maintenance is dependent on the equipment design, its intended function and accuracy
requirements. Activities are performed according to written protocol, following either the
equipment manufacturer's manual recommendations, contracted services protocols or the
facilities SOP. Preventative maintenance may be contracted out to equipment service
companies or performed internally.
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