The biomanufacturing industry is in the midst of a serious shortage of skilled bioprocess engineers, limiting productivity and the field’s ability to innovate and expand. For the industry to grow and accommodate revolutionary new drug modalities, like CAR-T therapies, far greater emphasis needs to be placed on training and retaining skilled workers.
As executive director and head of the Jefferson Institute of Bioprocessing (JIB), Parviz Shamlou, Ph.D. is working to address this multi-faceted problem by developing training programs for a new cohort of personnel who are proficient in the latest biomanufacturing technology.
Parviz will be discussing additional details about the JIB and its partnership with the National Institute for Bioprocessing Research and Training (NIBRT) as part of the Bio-Processing Symposium on Wednesday, May 1 at 11:45 am. Below, he shares insights into the origins of the biomanufacturing workforce gap and the JIB’s key initiatives, as the first and only education and training institute for bioprocessing in North America.
Parviz: Demand for legacy biologics, such as replacement proteins and monoclonal antibodies, is growing because these biologics are exceptionally effective. Also, radically different therapeutic modalities are emerging, such as checkpoint inhibitors, antibody drug conjugates (ADCs), CAR-T therapies, gene therapies, advanced vaccines, and so on, which are changing the nature of biomanufacturing industry itself. As a result, jobs in biomanufacturing are growing at a rapidly increasing rate. These jobs are exceptionally specialized and require a highly educated workforce with skills that need to be developed through a combination of formal education and tactile training in “real-life” settings. This workforce education has not kept pace with the growth of the industry and the evolution of training needs. This, in my view, has led to the current gap in workforce in biomanufacturing.
Parviz: JIB is in an academic institute, and so for JIB education is a vision. Thomas Jefferson University has invested significantly in infrastructure, people and resources to address the question of workforce education in bioprocessing and biomanufacturing. JIB is a state-of-the-art, 25,000-square-foot facility that houses a next generation, fully flexible and ready-to-use biomanufacturing platform. You know, Amgen built the first platform of this kind back in 2014 in Singapore and I believe WuXi is planning to build the largest such facility in Ireland. JIB’s facility is modest by industry standards and is not designed for GMP operation. We refer to JIB as “GMP-like” because we want to create a “real life” tactile training environment for our students and industry professionals who want to use the facility. The GE FLEX factory at JIB includes all the major unit operations from WAVE bags to a 200L bioreactor to column purification and tangential flow filtration and nano-filtration operations. The facility may be used to make gram quantities of API for pre-clinical studies and process development. But we want to use it mainly for training the next generation of scientists and engineers to help close the gap in the current workforce. There are multiple ways that we plan to do this. We are developing courses and programs including certificates for undergraduates, postdocs and everything in between. That is what I mean by education being a vision for us. The key point for JIB is that we will develop these programs through close partnerships with industry. Our programs will be industry-led, industry-defined and industry-relevant.
And through industry partnerships we will also provide training for industry professionals. In this area, we will work seamlessly with NIBRT – our partner in Ireland – to provide best-in-class training for industry professionals. NIBRT has a superb portfolio of industry training programs that will be available through JIB to industry professionals in the USA. This type of partnership has never been done before and is our way to help close the current gap in workforce.
Parviz: JIB has the infrastructure, resources and people to attract a new generation of young people to bioprocessing and biomanufacturing. We need to reach out to young people who are in STEM-based education to excite them about jobs and career opportunities in biomanufacturing. At Thomas Jefferson University we have a superb team dedicated to this goal. We're currently going to schools and community colleges, and inviting students for tours and internship opportunities at JIB. We're also creating programmatic partnerships with local community colleges, such as Bucks County Community College and Montgomery County Community College, to create a single pathway from high school to jobs. We give seminars and presentations at schools, community colleges and universities; any way of reaching out to people.
Why are we doing this? Because the jobs in bioprocessing and biomanufacturing are excellent, and the salaries are good. Career development and mobility is superb.
Parviz: By partnering with NIBRT, an exceptional bioprocessing training center in Ireland, we’ve been able to kickstart our facility much better and stronger. We have built a next-generation, ready-to-use facility, which will be the first of its kind in a university environment. The largest bioreactor we have at JIB is a 200-liter single-use bioreactor. Everything we do, all our programs are in partnership with industry; our programs are industry led; the learning outcome of our programs are industry defined. We are already, at JIB, and we have the capability to teach and train people with the latest technology that are actually used in biomanufacturing to make medicine for patients.
Parviz: The future of bioprocessing and biomanufacturing could not be more exciting or more challenging. We are moving from batch to continuous bioprocessing. This creates fantastic new opportunities for research partnerships and collaborations. Much of the research in this area in the past has focused on upstream operations, including, for example, perfusion bioreactors. Future research will also focus on continuous downstream bioprocessing to create a truly end-to-end continuous biomanufacturing platform. When you combine continuous bioprocessing with ready-to-use, flexible technologies you have the foundation for a totally new biomanufcaturing platform that can be used to commercialize radically new therapeutic modalities, from sophisticated next generations checkpoint inhibitors, bispecifics, fusion proteins and ADCs to CAR-T cell, gene therapy, advanced vaccines and regenerative medicine. That, I believe, is the future.
Let’s take CAR-T as an example of a radically new immunotherapy for certain blood related cancers. Currently, a patient goes to hospital, they take a small amount of blood and extract T-cells from it. Those T-cells are then shipped to a manufacturing facility. The cells are engineered so that they now are able to express certain additional new proteins, and those cells are then grown in a bioreactor, cleaned, processed, frozen, and shipped back to the hospital within about two weeks for infusion into the patient.
In terms of process development, scale-up (or in this case scale-out) of these processes, we are in infancy. What type of manufacturing platform would this type of autologous cell therapy require in the future? How do we develop allogenic based cell therapy processes that can treat millions of patients, more cost effectively? These are totally new types of therapies; they require new skills and hence new teaching and training, and at JIB we work and want to continue to work with our industry partners that are in that space.
I like to think that JIB will be involved in a great deal of industry sponsored partnership research, training and education to make all this happen, because that is the future.
Parviz: It takes a lot of intellectual horsepower to educate the skilled workforce that biomanufcaturing industry needs. JIB has the infrastructure, resources and people and is ready to meet the challenge. The actual facility, the infrastructure itself, is coming along rapidly. We've gone from the design concept to launch in 15 months; our ribbon cutting ceremony is scheduled for May 31st 2019. We have recruited a top leadership team, and trainers and instructors from the relevant industry and business communities. We are performing the necessary equipment and facility qualifications during the next few weeks and have every expectation that we will be ready to receive trainees in July. We already are talking with potential clients who are wanting to send people to the facility. We have received approval for a 12-credit certificate in biopharmaceutical process development and are recruiting students for fall of 2019. We are also developing other qualification programs and are in the process of completing a grant application for funds to partner with local community colleges and industry to create a new pipeline to entry level biomanufacturing jobs for young people.