Research Resources
Gene and Cell Therapy
Key Services:
- Comprehensive quality program for therapeutic product
development from benchtop to bedside, using current Good Manufacturing
- Practices (cGMP)
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Biosafety Level 2 and 3
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Experienced research staff and training
for investigator staff
- Regulatory oversight and assistance
- Product Development Consult Service to help you develop your own clinical product
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Evaluation of pre-clinical data
- Developing a management plan and timeline for product development
- Assistance finding cGMP-compliant vendors for reagents and disposables
- Assistance in developing FDA-compliant manufacturing techniques
- On-site visits to help you set up your own cGMP-compliant lab
- Reduced rates for apheresis
- Assistance with IND applications
including qualification scale-up runs
At your location: technical consultation and guidance in
translating basic science to a clinical trial
The GCTC Lab provides translational researchers with the infrastructure, education,
and technical expertise necessary to develop novel gene and cell based clinical
products for therapeutic applications. We assist investigators throughout the process,
from the research benchtop, through regulatory communications, to the manufacture
of products and infusion of volunteer subjects at the GCRC. Considerable research
support
is available to Category A investigators. To ensure the highest attainable level of
participant safety, we conduct all activities under a comprehensive quality assurance
program that is compliant with current Good Manufacturing Practices (cGMP).
Read on for more information or
skip to the steps to get started. Clean Rooms just steps from Patient Rooms
The GCTC Lab is located on the UW GCRC, facilitating the transfer
of patient samples between the clinic and the laboratory. The lab is composed of
four secure access critical environment suites (two Biosafety Level 2 suites and
two BL3). To prevent cross-contamination of products, each suite is outfitted with
dedicated equipment, including biosafety cabinets, incubators, centrifuges and microscopes.
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Research Support for Category A protocols, the GCTC lab provides:
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trained scientific staff
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reduced rates for apheresis
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gowning
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environmental monitoring
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autoclaving of biohazardous waste
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facility and equipment maintenance to comply with regulatory requirements
- documentation and regulatory support
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secure archiving of study samples
Investigators provide reagents, biologics and disposables needed for your clinical trial, as well as any protocol-specific equipment not available in the GCTC Lab.
Quality Assurance and Regulatory Expertise
To ensure subject safety and compliance with FDA and other government agencies, we provide regulatory, administrative and quality assurance oversight for all work conducted at the GCTC. Cathy Lindgren, our Lab Manager, has over twenty years of experience managing adoptive immunotherapy trials and is certified in Biomedical Regulatory Affairs by the UW. For each clinical trial, she documents and archives all required information, and she takes an active role in all interactions with regulatory agencies.
If you would like help setting up your own cGMP-compliant lab, give us a call! Our regulatory expertise is at your disposal.
Steps to get started using the GCTC Lab: