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Aldevron Breakthrough Blog
Building a Manufacturing Process, Step by Step
May 22, 2024 by Basam Barkho, Ph.D.
Webinar Recap: Exploring Solutions for Genomic Medicine Success: All starts with Plasmid DNA
Plasmid DNA is a critical material to any cell and gene therapy. However, drug developers run into challenges with manufacturing biologics due to complexities from plasmid yields, quality, and expression. Therefore, a viable solution to overcome these obstacles is to collaborate with a seasoned research and manufacturing partner. By leveraging a partner’s technical expertise, manufacturing capacity, and innovative plasmid technologies, developers can streamline the drug discovery and production process with greater ease.
In our recent webinar, ”Enhance your long-term cell and gene therapy success with pDNA manufacturing solutions,” Matt Howard, Vice President of Manufacturing and Tyler Kozisek, Senior Scientist, presented different solutions Aldevron offers in research grade plasmid manufacturing, and then addressed the audience questions in a panel session. The major topics discussed included quality and regulatory concerns, process optimization, scale-up, and enabling new technology to improve yields and expression of the plasmid.
The webinar shed light on the importance of developing the manufacturing process early to enhance the efficiency, reduce variability, and minimize intervention. Howard and Kozisek also addressed the key considerations for successful scale-up, including optimizing fermentation conditions, implementing efficient downstream purification methods, and ensuring scalability without compromising quality.
The webinar concluded by discussing the prospects and opportunities in plasmid DNA manufacturing with the next generation NanoplasmidTM vector system. This portion emphasized on the benefits around increased manufacturing yields, higher transgene expression, and improved safety profile by eliminating antibiotic resistant gene.