|
Gene & Cell Therapy Core Laboratory
-
Comprehensive quality program for therapeutic
product development from benchtop to bedside, using current Good
Manufacturing Practices (cGMP)
- Product Development Consult Service to help you develop your own clinical product
- 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 research
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.
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. (
additional details are included in our Copy-Paste Wording)
For Category
A protocols, the GCTC lab provides:
- trained scientific staff,
- reduced rates for apheresis,
- gowning,
- environmental monitoring,
- autoclaving of biohazardous waste,
- facility and equipment maintenance to comply with regulatory requirements
- documentation and regulatory support,
- 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.
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.
We'll come to you.
If you would like help setting up your own cGMP-compliant lab, give us a call! Our regulatory
expertise is at your disposal.
View a flowsheet of how we work with new investigators
Here's an overview of the steps to get started using the GCTC Lab. For more details, please
refer to the flowsheet at right.
Consult us before you seek NIH or other funding
As early as possible, the investigator should contact the GCTC Lab manager,
Cathy Lindgren (email
or 598-7038). We welcome applications from all UW affiliated institutions.
Budget.Laboratory techniques done in a cGMP-compliant
clean room facility are decidedly more labor-intensive and expensive than traditional
pre-clinical laboratory bench-top work. Please discuss your protocol budget with us prior to
submitting your grant proposal to NIH or other peer-reviewed funding agencies.
Prepare applications for the GCRC and IRB/Human Subjects Review Committee (HSRC)
- You'll need to complete the main GCRC application as well as the GCTC Lab appendix.
- At the same time, you should be preparing an application to your IRB or Human Subjects Review Committee (HSRC).
We gladly provide assistance with applications. We can also help you with clinical trial
design and human subjects protection and we encourage you to consult
with other GCRC managers as well.
After approval from the GCRC Scientific Advisory Committee and IRB/HSRC:
Set timeline to submit an IND application
We'll meet to plan qualification runs in preparation for an Investigational
New Drug application. We'll also discuss cGMP requirements and training, other regulatory
applications you may need to submit, Standard Operating Procedures (SOPs), and procedures for
ordering and delivering supplies and reagents for the trial.
Draft cGMP-compliant Standard Operating Procedures
We provide investigators with a template for use in developing precise SOPs. The SOPs should
include as much detail as possible. The GCTC research staff will use your draft SOPs during
qualification runs and will suggest modifications. After final editing and approval by the
Lab Manager, the SOPs will form the basis for a document control system.
Train all technicians in cGMP and the protocol
GMP requires two people in the lab whenever a procedure is underway (one to perform the task and
another to verify and document that it has been carried out in accordance with SOPs). We
provide one technician and we rely on you to provide the other. Due to illnesses and
vacations, the investigator should identify two people who will work in the lab.
Your research staff will receive special training and documentation of their GMP understanding
and proficiency. In addition, all personnel must have documentation of recent TB testing
(within the last 2 years) and a positive titer against Hepatitis B (HepB vaccination).
Our GCTC research staff will also need to be trained on the protocol in your laboratory.
Ready to get started?
Start the application
process and give us a call.
|