By Jayanthi Grebin, Sr. Business Development Manager CGT at CPC - Colder Products Company
The cell and gene therapy (CGT) industry is growing rapidly, due to their potential to target chronic and rare diseases that previously had limited treatment options. Yet, there are many challenges to developing these innovative new therapies that cannot be addressed using traditional manufacturing models and processes. Historically, these therapies are produced for small patient populations in clinical trials using laboratory scale equipment and utilizing manual, open processes completed under laminar hoods. An increased focus on efficiency and flexibility from the biopharmaceutical industry has accelerated the adoption of novel technologies and solutions to manufacture cell and gene therapies. Among these advancements is the implementation of a closed system design utilizing single-use technology (SUT).
Lab equipment originating from medical processes are quick and open to the environment and must be performed under laminar hoods to prevent contamination while closed systems are self-contained in order to prevent exposure from and to the environment. Thus, a closed system in cell and gene therapy manufacturing provides the protection of a cleanroom against outside contaminants without the costs associated with maintaining it. Although closed systems are already in use in SUT facilities for monoclonal antibodies, recombinant protein, and vaccine production, there is still a lag in the adoption of closed system at lab scale for smaller batches, such as in CGT manufacturing.
As the demand for CGT grows, the need for scale up to larger volumes has led to the utilization of SUT bag assemblies and as a result, open connectors as well as other methods and products, such as tube welding, multi-purpose connectors, quick connects, luers, and luer locks. These approaches are cumbersome and inefficient, though, leading to a greater need for closed manufacturing in CGT to protect and provide effective therapies.