Quality Assurance in Cell Therapy Manufacturing
Cell and gene therapy production is a complex process that involve many moving parts. As a result, this production can easily drift out of compliance unless strict quality measures are put in place.
This complex nature of cell and gene therapy production makes it necessary to make quality front and center of the entire cell therapy system. Hence, quality involvement begins long before clinical production; specifically, it begins during the process development phase.
Cell and gene therapy regulations has evolved over the years with requirements that are intended to ensure the highest quality of the final products. One requirement is for the cell and gene therapy to include an independent quality assurance unit to oversee the compliance side of the clinical production.
Who is Quality Assurance?
Quality Assurance (QA) is a team of professionals of diverse expertise but with a regulatory focus. Many QA members have a regulatory background from working in regulatory agencies or advisory firms. Other QA members may have technical cell and gene therapy background as former technologists or scientists. With their deep experience, QA provide a valuable regulatory insight to researchers who intend to develop cell and gene therapy product for clinical applications. QA insights ensures compliance throughout the entire journey of the product from development to clinic. For instance, QA ensures the product development is being performed in a compliant manner with the right documentation, the right material, and the right approvals. The QA involvement continuous through research translation, personnel training, production documents, and product release, among other stages.
Why QA?
Personnel of cell and gene therapy production may have a strong regulatory background, specially those of leadership team members. However, their involvement in production makes them too close to the process that they may not notice some occurrences. Besides, production personnel have their own technical experience that may make their judgment a little biased towards their work. As a result of these factors, it is needed to make QA representative independent from production.
Another reason to have a QA is the depth and width of their regulatory experience. With such experience QA can help identify even the hidden deficiencies. Additionally, QA may design a road map to compliance, or an exit from deficiency with the least possible interruption to clinical production.
How it works?
QA representatives and production personnel work closely as a team. The beauty of such setting becomes evident when this team work on a new project. In this work, you find the technical and the regulatory aspects of the project are being handled simultaneously and in an efficient way. I have enjoyed teaming up with QA representatives before, and I believe doing so led to successful clinical production.
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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