GMP_FOTP

CIRM UCI Good Manufacturing Practice Facilities Operations Training Program

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 Facility Operation Training Program?

Working in a Good Manufacturing Program (GMP) lab requires a highly specialized skill set. The high demand for workforce development in this area makes this program a key pathway for students interested in pursuing careers in biomedical research. The GMP Facility Operation Training Program (FOTP) is a certificate training program that will provide introductory training to prepare bachelor’s and master’s level students for careers in GMP facilities for cell and gene therapy

 

The intent of the FOTP is to create a path by which to introduce underrepresented minority, first generation college students, and STEM/non-STEM majors alike, to career paths in regenerative medicine that they may not have previously either been aware of or considered – specifically cell and gene therapy development and manufacturing. Consistent with this goal, the FOTP is not intended to provide in depth GMP training; there are existing programs for that goal both within and outside California (e.g., the long running UCD Cell and Gene Therapy Manufacturing Specialization program that includes both online courses and in- person bootcamp). We have linked our introductory FOTP to on-ramps for additional training that would enable students that choose to pursue cell and gene therapy manufacturing.

 

 

Target Audience

FOTP cohort size will be limited to up to 10 trainees per session to maximize hands-on opportunities in the cGMP Facility. We will offer this training course annually in the summer for a total of 86 hours of instruction.

 

Tuition

Tuition for this program will be $5,000 USD, with waivers based on need.
There are tuition scholarships available for undergraduate students.

 

Program Objectives

• Understand GMP requirements and become familiar with regulatory guidelines.
• Understand specific characteristics of cells and their manufacturing processes.
• Gain practical experience in single use technologies.
• Be familiar with the various roles of QA, QC, materials management, and manufacturing processes.
• Gain exposure to GMP practices with hands-on experience in the lab.

 

Program Requirements for Trainees

• Seven (7) week program consisting of half day hybrid format with online and in-person lectures.
• Four (4) weeks of in-person hands-on training.
• Collaborative case study workshop with USC.
• Industry networking opportunity with Miltenyi Biotech.
• Trainees will need to complete daily assessments and a final exam to receive their certificate.
• A total of 86 hours of instruction.

 

Curriculum

The program will cover the following topics associated with GMP Facility Operations

• Documentation
• Standard Operating Procedures
• Regulatory Guidelines
• Process Development
• Process Development and Manufacture
• Batch Record Development and Materials Management
• Career Development with an Industry GMP Facility, Miltenyi
  • Manufacturing: Close System and Scale Up
  • Joint Career Panel Workshop

 

Curriculum

Trainees are expected to achieve a minimally acceptable multiple-choice test score at the end of each daily session and demonstrate acquired practical skills at the end of the hands-on rotational period where trainees will need to create a batch record utilizing all the knowledge learned during the program. At the end of 7-weeks there will be a cumulative final.

 

After successful completion of required assessments, which will be administered for each area of program instruction, trainees will receive a UCI School of Medicine Office of Medical Education certificate verifying their completion and competencies.

 

Internship Opportunities and Career Development

All trainees that successfully complete the program will be eligible to apply for paid internship
position(s) at the UCI GMP Facility and within an industry GMP Facility. 

 

If you have any questions about the program, please contact:
Dr. Monique Williams(monique.williams@uci.edu) or Ephie Bakou (ebakou@hs.uci.edu).