Senior Medical Scientist
Cell and Tissue Therapies WA (CTTWA)
Royal Perth Hospital
It is no exaggeration to say that advanced biomanufacturing of cell and gene therapies is flourishing. Entire career paths now exist that never did before. It is now conceivable that a new employee may enter this field as their first job upon graduation and never leave the field until retirement. Many of us have come to the field later from a broad range of previous careers and skillsets. The critical shortage of skilled labour globally is a common difficulty faced by agencies across the sector trying to meet the burgeoning demand for advanced therapies. There is a significant gap in specialist biomanufacturing knowledge at all levels.
The combined ISCT – CMaT Workforce Development in Biomanufacturing course has been developed to address the challenge of these critical skills shortages. The course is the result of a partnership between ISCT and the National Science Foundation Engineering Research Center for Cell Manufacturing Technologies (CMaT) at the Georgia Institute of Technology. The second iteration of the course, designated Fall 2022, has recently ended. There were sixty-one participants who came from all five ISCT regions and who were nearly evenly divided between industry (48%) and academia (52%).
The course is divided into four broad modules. The first covers stem and immune cell engineering and therapies, including pluripotent and multipotent stem cells, adoptive cell transfer, gene editing and CAR T-cell therapies. The second covers quality assurance and regulatory frameworks, including content on GMP, ethics and policy. The third module is the largest and covers cell bioprocessing and manufacturing, including aspects of supply chain management and distribution. The fourth module is for product characterization and standards, but also covers automation, data management and machine learning. In amongst the modules are fascinating lectures on scalability, bioreactors, biomaterials, microcarriers, and cryopreservation.
This course is for everyone, whether they are fundamental researchers, process development or manufacturing scientists, quality officers or logistics personnel, as it provides a very broad overview of the entire field at a range of operational scales. Learners new to cell and gene therapy are in for a treat, and there is a lot of ground to cover. Seasoned operators may certainly learn new things or appreciate fields they were already familiar with in a different light. Exposure to a range of technologies one may not have considered before might provide a critical light-bulb moment applicable to one’s own practice, or demonstrate a range of options that may be of use or importance to one’s role or organization at some point in future. Participants will come to appreciate sectors of the field outside their immediate roles. It pays to see how the disparate parts of the whole come together toward the final goal of delivering advanced therapies to patients.
There are over 16 hours of content, including twelve pre-recorded lectures, that could be viewed at the participants’ convenience. All lecture slides are provided as handouts, and every lecture has a multiple-choice quiz made available at the end of each video that must be passed in order to proceed. Each of the lectures had a range of two to five presenters, and each lecture was partitioned into a Theory component as well as an Application component. The Application components were generally delivered by experts from industry who expanded upon their experiences with the topics at hand in real-world industrial contexts. It’s a cleverly structured program and avoids the pitfalls of academic courses that may deliver theory that doesn’t align with actual contemporary practice.
Each of the four modules had a live online Q&A forum held weekly over the month of November, where participants could ask questions of their lecturers in an open discussion format or post long-form questions in the module’s discussion forum and chat boards. As the course was delivered from the USA, but the participants spanned the globe, time-zone roulette required some late nights for participants in Asia and Australasia. As the sole participant from the ANZ region, that arrangement generally suited this night-owl. However, my colleagues further east of GMT +8 may have found it more challenging. Fortunately, live attendance was not compulsory as the content was recorded and may be viewed at a more convenient or appropriately caffeinated time.
All manner of questions are welcomed from whatever level of expertise the learner’s background, novice or otherwise. Difficult questions are dealt with in a thoughtful and considered manner with much useful discussion between the participants, representing the nature of current opinion and knowledge as it stands in a nascent and rapidly growing field. The input from the industry-based speakers was especially useful. The module discussion boards are worth reviewing after the live sessions and at the end of the course, as further comments and replies get added over time.
There is perhaps scope for additional region-based modules to tie into this course in future, for example, to explore local regulatory regimes and requirements.
Do I recommend this course to improve the skillsets of you or your workforce? Absolutely, yes. Pleasingly, the increased demand for the course has seen its projected offering expand to three times a year, to be run in Northern Hemisphere Spring, Summer and Fall/Autumn. The next course is scheduled to run 15FEB-21APR2023, and registrations are now open via the ISCT Workforce Development in Biomanufacturing webpage.