Internships at the GMP facility: My short experience as a Mentor
News Article by Luisa Caetano-Davies, Principal Scientist and Facility Director of The Upstate Stem Cell cGMP Facility
I met Brianna Shares, a current URBEST intern in my lab, in 2017, the first year I was teaching MBI406: Biomanufacturing, after auditing the same course myself the year before!
Back to 2016, I was a post-doc and I was far from imagining that my own URBEST internship at the Upstate Stem Cell cGMP (Good Manufacturing Practice) Facility (USCGF) would be my passport into USCGF management, business development and mentoring of students at my fingertips. The decision to audit MBI 406: Biomanufacturing came from a personal decision to look for opportunities outside academia, and above all to work in programs where I could feel that I was directly impacting people’s lives. The chance to use the URBEST internship to discover what is beyond research was all that I was looking for! The questions back then were the same that still thrill me in my every day role at the Facility; how do cell-based therapies transition from hypothesis to people? How do we make sure that those therapies are safe? What are the steps involved in the production of clinical grade materials in clean rooms?
The USCGF is located in the basement of the MRBX building, a truly hidden Oasis! We work as a team for the manufacturing of cell-based therapies for clinical trials. Our culture is industrial in its nature. As part of the production of materials to be tested for the first time in human clinical trials, we assure product safety, purity and potency by the documentation of process and procedures, qualification of equipment and analytical methods. We scale-up the manufacture of clinical grade products, while following the FDA (Food and Drug Administration) Code of Federal Regulations 21CFR210, 211, as occurs in biopharmaceutical companies. The fact that the GMP facility is in the University is a plus because students can tour it and have a glimpse of what is happening in a Biotech company manufacturing setting.
The MBI 406: Biomanufacturing course is a space where invited speakers from Industry and other GMP facilities present and provide trainees (undergraduates, graduates and post-docs) with networking opportunities. While teaching MBI 406, I incite students to explore work outside academia, and start networking, networking and networking as a base for career development! You may ask, what if they don’t like it outside academia? It is part of the learning journey and they can go back to their research labs to follow their dreams, if academia is their goal. But if they like it outside academia, now they have the motivation to follow their dreams on a different path. It works both ways!
Brianna was an MBI 406 student and she has been trained at the GMP Facility within our new program with Torque Therapeutics on cancer immunotherapy. She has been pivotal in the tech transfer process from the company research labs in Cambridge-Boston and process development at UC Davis GMP lab to the USCGF. Right now, we are performing Engineering and Qualification runs for the production of almost a hundred of autologous therapeutic doses and starting production in 2019, as part of phase 1 and 2 clinical trials. Brianna started her internship by qualifying a mycoplasma RT-PCR assay to be used as one of the release criteria. So far, she has embraced all the opportunities that this internship has provided her, excelling in all of them! Rob Maynard, an MBI 406 grad student, just joined the URBEST/USCGF internship, and he is starting as a checker of our batch records during Engineering and Qualification runs and he is already up for much more! I hope that their experiences with the USCGF will help them in their careers after they complete their PhDs.
I had many mentors during my life, and I am grateful to all of them for the possibilities that they could present me with. My own experience shaped me as a mentor, and I want to provide GMP interns with opportunities and possibilities for their future careers. I love the sparkle in their eyes.
Read about the mentees’ experiences with the GMP Facility
Tracey Baas |