GMP_GPTP
CIRM UCI GMP Professional Training Program: Regulatory Guidelines and Manufacturing for Cell and Gene Therapy
Applications are due March 28 th, 2025 at 11:59 PM
Who is CIRM?
California Institute of Regenerative Medicine (CIRM) Stem Cell Agency’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world. CIRM is committed to tackling these challenges by creating a diverse and dedicated workforce that can meet the technical demands of translating novel treatment paradigms to reality, while engendering the necessary appreciation for and sensitivity to the perspectives and participation of communities that have been historically under-represented in the biomedical sciences.
About the GMP Facility at Hewitt Hall
Launched in 2024, UCI’s state-of-the-art GMP facility was established to produce FDA-compliant cell and gene therapies. It is uniquely poised to specialize in the production of cell and gene therapies for clinical trials in neurological diseases and cancer, significantly expanding treatment options for our patients and positioning UCI at the forefront of pioneering novel regenerative treatments into clinical practice. The approximately 7,700 square foot GMP facility is located in the basement of Hewitt Research Hall with a manufacturing space, a storage warehouse for raw and finished products, and support laboratory areas, including space for quality control testing. It is a multi-use facility with 7 separate manufacturing rooms, designed to operate at Biosafety Level 2 (BSL-2) serving both internal and external clients. You can learn more about the services and resources the GMP Facility offers here.
What is GMP Professional Training Program?
UCI launched a new cGMP Facility last fiscal year to enable innovative new treatments using cell and gene therapies (CGT), including engineered chimeric antigen receptor (CAR)-T, natural killer cells and advanced bone marrow transplant protocols to enhance treatment delivery to patients with a wide variety of conditions. Additionally, the GMP Facility also launched the Facility Operations Training Program (FOTP) aimed at early career trainees as part of workforce development for GMP technicians with great success.
The GMP Facility also recognizes that scientific leadership is critical for cell and gene therapy (CGT) development, and understanding of GMP processes can help to move promising innovations out of the lab and forward into clinical development. In response, we are launching the GMP Professional Training Program (GPTP). The GPTP certificate will be geared towards graduate students, postdoctoral scholars, research scientists, clinicians, faculty, and other professionals working in or advancing cell and gene therapies from discovery through translation to clinical application with the goal of providing a deeper understanding of techniques, regulatory requirements, and GMP support for CGTs for science professionals, for use in academic or industry settings.
Target Audience
Professionals that have or are obtaining advanced degrees (MS, MBA, PhD, MD, PharmD, etc) or with years of GMP experience. The GPTP cohort size will be limited to 10 trainees per session.
Tuition
Tuition for this program is $1,500 USD, and scholarships are available .
Program Objectives
- Understand the gap between basic science, process development, and GMP manufacturing and production.
- Become familiar with GMP requirements and with CGT regulatory guidelines.
- Understand the transition from the research or clinical environment to the GMP site (e.g., chemistry, manufacturing, and controls).
- Understand the relevant sections of an investigational new drug (IND) application and tech transfer procedure.
- Develop familiarity with the various roles of quality assurance, quality control, materials management, and manufacturing processes.
- Gain exposure to GMP practices (IND process application, tech transfer documentation, active protocol shadowing).
Program Requirements for Trainees
- Six (6) week hybrid program consisting of weekly two-hour lecture sessions on Tuesdays from 6:00-8:00 PM over Zoom.
- Weekly assessments and a final certification exam.
- Trainees will be required to complete an in-person Case Study assignment.
- The GPTP will be offered annually with 12 hours of instruction.
Curriculum
The program will cover the following topics associated with GMP Professional Program:
- Introduction to GMP, Documentation Requirements, & Regulatory Compliance
- Process Development and Quality by Design Attributes
- GMP Start-up Requirements and Technology Transfer
- Case Study Development, Guided Tour of GMP Facility, Meet the Staff, Q&A
- Case Study Development - CAR-T for Hematologic Malignancies
- CIRM GMP Network & Industry Partnerships
- Investigational New Drug (IND) Application and Coordinating with Clinical Trials Units
Case Study Curriculum:
- Introduction and Overview of CAR-T Therapy
- Manufacturing Process including Collection, Genetic Modification, Expansion and Quality Control, Cryopreservation and Transport
- Regulatory Compliance and Regulatory Framework and Good Manufacturing Practices (GMP)
- Clinical Application including Patient Selection and Treatment Protocol
- Assessment Criteria by evaluating Manufacturing Success Rates, Efficacy, Safety
- Manufacturing Challenges and Potential Solutions
- Concluding with a Summary and Future Directions
Program Assessment
Trainees are expected to achieve an acceptable multiple-choice test score at the end of eac h w eekly session, successfully complete a case study assignment, and at the end of 6 weeks complete the cumulative final.
After successful completion of program requirements, trainees will receive a UCI School of Medicine Office of Medical Education certificate verifying their completion and competencies
Required Application Documents
- Completed application form – Click the "Apply Now" icon below to access the online application.
- Upload an up-to-date version of your CV (PDF preferred)
- Resume (optional) (PDF preferred)
- Letter of Support or Interest (PDF preferred)
All applications will be reviewed by the GPTP selection committee
Applications are due March 28 th, 2025 at 11:59 PM
We will confirm our cohort of GPTP Trainees April 1, 2025
If you have any questions about the program, please contact:
Dr. Monique Williams ( monique.williams@uci.edu ) or Ephie Bakou ( ebakou@hs.uci.edu)