5 Questions for Cat Willis, PhD

This question-and-answer series explores the motivations, inspirations and accomplishments of investigators at St. Jude. Cat Willis, PhD, is the Director of Quality Control in the Good Manufacturing Practice facility at St. Jude.

1. What is a current Good Manufacturing Practice facility, and why does St. Jude have one? 

A current Good Manufacturing Practice facility, or cGMP facility, is a production environment that manufactures pharmaceuticals and bio-therapeutics under strict regulations to ensure every product produced meets quality and safety standards. Part 21 of the Code of Federal Regulations (CFRs) in the United States describes standards that a cGMP facility must adhere to. The 21CFR covers everything from how the facility should run and be maintained to how products should be tested. It also describes how records should be kept and how personnel should be trained. The cGMP production environment must remain clean and controlled to prevent contamination and maintain product stability to ensure consumer or patient safety. A cGMP facility has multiple departments involved in product manufacturing and release. Specifically, Children’s GMP, LLC has departments such as Process Development, Analytical Methods Development, Manufacturing, Materials Management, Quality Assurance, Operations and Quality Control. In my area of responsibility, Quality Control (QC), it is our job to ensure the quality of every product before it is released for use. QC develops analytical methods, qualifies these methods as fit for use and conducts product release testing protocols to verify that products meet predefined specifications.

St. Jude was one of the first pediatric hospitals to have their own cGMP facility when Children’s GMP, LLC opened in 2003. Having a cGMP facility at St. Jude is a huge asset because the manufacturing priorities of the facility are aligned with the strategic initiatives of St. Jude.  St. Jude investigators can have the biological agents studied in their labs with potential therapeutics manufactured on-site at the high standards necessary for clinical research and patient use. Having a cGMP facility integrated within St. Jude speeds up the process of taking new treatment approaches from the laboratory into the clinic and lowers the cost. Children’s GMP, LLC has the proper facilities, skilled staff and institutional support to bring products from bench to bedside. 

2. What does your role as Director of Quality Control entail, and why is it important to ensure the safety of cell products? 

The Quality Control Department plays a pivotal role alongside other essential departments in the cGMP facility by helping to maintain the highest standards of product quality and safety for all the therapeutics we manufacture. I typically describe the quality departments (QC and QA) as “the gatekeepers of quality.” By leading the QC team, ensuring regulatory compliance, developing and qualifying testing methods and continuously improving QC processes, I help ensure that the products manufactured meet safety and quality standards.  As QC Director, part of my responsibility includes participating in cross-departmental meetings where we learn about new products being discovered at St. Jude. Once a product meets the criteria to be manufactured by Children’s GMP, LLC, I help formulate a statement of work for how the QC team will test this drug product for safety, quality, purity, identity, dose, potency/functionality and stability. I work with the QC team to develop assays for testing new drug products. I write and review protocols and sections of investigational new drug applications. I also maintain the QC schedule to make sure we meet institutional timelines. Our work at the GMP facility is an essential component to achieving strategic objectives that support the institution’s mission.

3. What do you like most about being a scientist?

At heart, it is in my nature to think systematically and want to solve problems. Being a scientist allows me to embrace that part of who I am by fulfilling a need to continually learn, explore new ideas, find innovative solutions to problems and analyze the interconnectedness of it all. I love my job at Children’s GMP, LLC. The work I get to be part of each day truly excites me and makes me enthusiastic about the new projects we have on the horizon. Knowing the impact of the QC efforts undertaken in the cGMP facility and how they contribute to the scientific advancements at St. Jude drives my dedication to our team, ensuring that patients receive safe products that meet the highest quality standards.

4. What do you wish you could tell your younger self about your career in science? Is there any advice you’d give to early-career investigators considering a similar career? 

I think back to when I was an undergraduate applying to graduate school. I remember writing an answer to an essay question about why I wanted to pursue a career in science. I wrote about my dream of a career in science, driven by the passion to make a difference and contribute to translational research. So, if I could give my younger self some advice, it would be to hold on to that vision. The path ahead may be winding, at times, seemingly long, but every twist and turn was a vital part of my journey to St. Jude. I would tell myself to trust the process, even when the years feel drawn out and uncertain. Embrace each lab experience and learning opportunity along the way, allowing space for grace and unexpected opportunities. And despite the unpredictability, perseverance and dedication will eventually lead you to that career you dreamed about nearly two decades ago — a career that makes a meaningful impact on patients' lives.

For anyone who would like to pursue a career in an industry-like position but who is in an academic research lab, I would suggest that you make a point to develop your record-keeping and documentation skills. These skills will be your friend as you advance your career. I would also recommend that you start writing up standard operating procedures (SOPs) that identify critical steps of your experiments and keep track of the reagents used to perform them. This will give you a better understanding of your results and improve the reproducibility of your experiments. Also, take an interest in regulatory science. Join meetings and reach out to people who have a job in industry to see what it’s like and if it is the right path for you. 

5. What is an accomplishment you are proud of in your work at the GMP?

One of the therapies we manufacture in the cGMP is called chimeric antigen receptor (CAR) T cell therapy. CAR T cells are a type of immunotherapy that guides the immune system to better attack cancer cells.  One of the accomplishments I’m most proud of from my time at Children’s GMP, LLC is contributing to the development of the release testing platform for CAR–T cellular therapies. I played a role in various QC processes, from implementing the necessary instrumentation for product analysis and validating equipment and software to writing SOPs, developing and transferring release assays, qualifying these assays, testing production development runs and then finally going live to test our first batch of SJCAR19 CAR-T cells for patients. This undertaking required a lot of planning and collaboration (and some trial and error) but has resulted in a highly successful program, in which I’m honored to have participated.

Over the years, we have fine-tuned and streamlined the release testing process, greatly enhancing our capabilities and efficiency with state-of-the-art instruments. Recently, the GMP QC team partnered with an exceptional team from our industry partner QIAGEN to integrate the QIAcuity digital polymerase chain reaction (dPCR) instruments into our release testing platform. With their support, we successfully transitioned several of our more “senior” assays to this streamlined dPCR platform, significantly boosting our release testing capacity.

Overall, I’m very proud of the collaborative effort that went into building our Cellular Therapy Program in the cGMP facility. Many dedicated individuals contributed to the program’s success and I’m grateful to have been a part of the journey. Our GMP team has achieved remarkable feats, from our skilled manufacturing team to our quality groups, who boast one of the fastest turnaround times for phase 1 cellular therapy product release in the country. It’s also noteworthy that we have the full capability to take a cellular therapy from A to Z. Our GMP manufacturing team produces all the necessary drug substances required to manufacture the cellular therapy drug products. St. Jude has quite a special asset in Children’s GMP, LLC.