Tackling the key challenges in viral vector manufacturing
Though viral vectors are used extensively in cell and gene therapy, the challenges of manufacturing such complex biologics at commercial scale is still a limitation to its broader use.
The primary challenge gene therapy companies are confronted with is the simultaneous need for both quantity and quality of their products. High yields and productivity are essential to keep costs per dose low, but quality is vital for the efficacy and safety of therapies. So finding the right manufacturing solution that provides both quantity and quality is crucial to the success of gene therapy companies. Furthermore, the analytical tools required to understand and optimize the manufacturing process add another layer of complexity to the equation. Without the right analytical tools, it is impossible to understand where a process has gone wrong, and how to fix or improve it.
Tackling the problem of quantity happens mainly in the upstream process. This optimization involves selecting the right components, such as plasmids and cells, and fine-tuning various bioprocessing parameters to achieve the highest possible productivity. At DINAMIQS, we have set up a manufacturing platform that delivers high yields, which can be readily applied to our clients’ projects, ensuring maximum productivity.
Quality is equally important and ensuring vector quality involves a complex journey that includes customizing and optimizing the downstream purification processes. DINAMIQS has a proven purity platform, which has been applied successfully to a variety of vectors, but customized solutions are often needed. Our dedicated process development phase delivers tailored solutions for optimal purification. Eliminating empty particles from AAV preparations and enriching them with the therapeutic genome (i.e. full particles) is one of the significant challenges related to product quality. However, process related contaminants, like enzymes, chemicals and host cell proteins, must also be minimized to ensure the quality and safety of the final product.
Optimizing through analytics
Analytical challenges are an intrinsic part of the viral vector manufacturing process. Comprehensive analytics and quality control are crucial for understanding the process and product. Our approach is to integrate analytics as early as possible during the process development to achieve a comprehensive understanding of the process and product right from the start. This early insight allows for timely optimization, preventing issues from arising at the end of the process. We emphasize the use of the latest and cutting-edge analytical technologies to stay at the forefront of the field and ensure that we can adapt, change, and optimize processes as needed. Early detection and adjustment are key to our approach.
Leveling up and offering more
As a Siegfried company, we are able to leverage Siegfried’s 150 years of expertise to further support our clients in tackling their challenges. With access to Siegfried’s fill and finish capabilities, combined with the build out of our GMP facility, we will soon be able to offer clients high quality viral vectors at large scale for clinical applications.
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