After reading my previous article “Why Join the Cell & Gene Therapy”, you probably were thinking:
“all right, these are all valid reasons to join cell and gene therapy, but how would I master the skills of a field that uses different cells, different techniques, and different production platforms?”
I actually agree with your thought; I also think these are more good reasons that should be added to the article, but I know this is not the point you are trying to make.
To respond to your point, I will talk about two folds. First, think of those different cells, techniques, or platforms as different airline companies that can take you to your destination, but each of them has its own cons and pros. For instance, one airliner might be faster to reach the destination, but costs more money. While another airliner may have tight leg space, but operate electrical jets with zero emission (I don’t think we have these yet); anyway, you get the point. So, these airliners are the same with respect to reaching the destination, but they do that with variations.
Second, and even more importantly, although those cells, techniques, and platforms look different, they actually share significant parts, and that is the secret. What this mean is, by mastering only the shared parts, you go long way towards being a cell and gene therapy professional; all you need next is to learn some variations which is the normal practice in cell and gene therapy arena due to its ever-evolving nature.
What is shared?
I have just clarified how using different cells, techniques, and platforms is actually not a barrier towards becoming a cell and gene therapy professional, I will next list three major skills shared by almost all processes.
- Aseptic Processing: whether your process starts with NK cells, T cells, or CD34 cells, the product need to be handled in an aseptic manner to protect both the operator and the product. This aseptic process is mandated during ALL stages of the clinical production process, starting with the first manipulation until the final packaging. Therefore, mastering the aseptic processing is critical to being cell and gene therapy professional.
- Cell Sorting: as the name indicates, cell sorting is to sort your product into several parts to enrich for the cell type you are interested in. Many cell and gene therapy processes use the magnetic activated cell sorter (MACS) to select the target cells like T cells or CD34 cells. Generally, cell sorting follows a standard process regardless of the enriched cell type. Mastering the cell sorting provides you with a very important skill that many cell and gene therapy processes utilize.
- Good Manufacturing Practice: the good manufacturing practice (GMP) is a set of quality standards that define how every aspect of the clinical production is completed. For instance, GMP defines how clinical production is documented and verified, and also defines what training is required for the operators and how such training is documented. All clinical production of more than minimally manipulated (MMM) products or advanced therapy medicinal products (ATMP) is mandated to follow the GMP system. Currently, MMM or ATMP comprise the majority of cell and gene therapy products, which means majority of cell and gene therapy production is mandated to be GMP-compliant. Therefore, training and mastering GMP is a major addition to your expertise, and makes you a competent professional.
Now, you have the key to efficiently becoming a cell and gene therapy professional. Start with these three areas, once mastered, continue sharpening the saw by learning the variations, one at a time.
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