Is Your Cell Therapy Manpower Ready?

The cell and gene therapy field is growing around the globe at a pace that is even faster than before. As a testimony to this growth, the American Society for Cell and Gene Therapy (ASCGT) in their Q1 2022 quarterly report reported that financing cell and gene therapy startups in the 1st quarter of 2022 reached $507.8M, with an increase of 5.8% over the same period of 2021.

The kingdom of Saudi Arabia and the region are no exception; the progress in localizing cell and gene therapy is evident with several programs being underway and at different stages. As I discuss in a separate article “Your Role in Cell & Gene Therapy Ecosystem”, multiple components need to be developed for the entire system to be functional. Components like Research Clinic, Regulations, and Cell Production are all essential, and are mostly underdeveloped. In this article I’ll focus on “manpower” of the Cell Production component.

The first image that usually jumps to readers mind when cell and gene therapy manpower is discussed, the first image is usually that of operators in bunny suits working in a cleanroom laboratory. While this image is not wrong, it is though incomplete. Operating a cell and gene therapy program involves several levels of engagements of different personnel with different qualifications. I’ll next list the involved categories and briefly discuss each one’s role in cell production.

• Operators

This category covers personnel that work on cell and gene therapy products from receipt to packaging. Operators of cell and gene therapy are highly trained personnel, their training involve not only the process-specific techniques, but goes beyond that to involve good manufacturing practice, essential knowledge, and basic techniques.

• Quality Assurance (QA)

QA personnel of cell and gene therapy studies are closely involved in everything related to production, including the process development studies. QA not only release the final product, but they actually assure that every step towards the final product was performed per protocol. Fir instance, QA reviews the protocols, material, specifications, testing, and training among a long list. Production of cell and gene therapy product is a collaborative work between operators and QA.

• Quality Control (QC)

The QC group is the one that monitors the quality of the production environment (facility) and operators. Specifically, QC monitors the facility air quality through testing for number of particles (viable and non-viable), testing of surfaces, and testing of operators gowning quality. QC then provides data that help leadership identify patterns and tending in all parameters. Based on these data, leadership may make changes in protocols to correct a situation than can potentially lead to a real issue.

• Facility Personnel

Ensuring that the facility as a whole is functioning correctly requires monitoring of several key parameters. For instance, facility personnel monitor the cleaning cycles of the facility to make sure they match the facility status; each facility status mandates a specific level of gowning, cleaning, and flow. Further, facility personnel monitor the building access system, periodic procedures, and maintenance.

With the cell and gene therapy field in KSA and the region being in its development phase, expertise in clinical production is scarce. Developing the above listed categories of personnel is time consuming. And when developed, getting these categories to be operating cohesively within a system is also important, to make sure activities are planned to go in the right sequence. 

Our observation indicates that recruiting and developing cell and gene therapy manpower is a challenge even in regions where cell and gene therapy is well established such as North America and Europe. As a result, and in preparation for the next era, the Cell and Gene Therapy Catapult in the United Kingdom has initiated a long-term plan to build their manpower base. Through this plan, the catapult increased UK’s advanced therapies workforce from 1,500 in 2019 to 3,000 in 2020; the UK demand for skilled workforce in 2026 is predicted to be 6,000.

KSA needs a cell and gene therapy development program at the national level to plan and lead the activities to prepare the entire ecosystem, and specifically to develop the under developed ecosystem components such as the manpower. This is critical because clinical cell and gene therapy production need to be carried out by the right operators, following the right protocol, within the right parameters, and in the right facility.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here