Polyplus, part of Sartorius, agreed to collaborate with MarkHerz, a Korean cell and gene therapy (CGT) CDMO, to develop new CGT efficiency standards focused on decreasing cost and increasing quality per dose of a therapeutic product. The teams will work to improve process efficiency leveraging Polyplus products and expertise with MarkHerz manufacturing capabilities. Polyplus’s e-Zyvec® technology will be used to design tailor-made plasmids for manufacturing. Plasmid engineering and production services will initiate the project, followed by upstream optimization.
“Because every CGT process is unique, we believe that working with plasmids optimized to each process should greatly impact yield and quality. Working with a team like Polyplus that understands both the intricacies of how critical materials work with one another and how to solve the scientific and process challenges is key for our customers success,” said Seungmin Lee, CEO at MarkHerz. “The FAS and scientific support teams at Polyplus will align with the process development team here at MarkHerz to optimize each process. Work will be performed across serotypes to collect data that is used to fine tune critical process parameters.”
“This is a first collaboration for the Polyplus team focused on the impact of tailor-made plasmids on large-scale manufacturing in Korea. We want to achieve the highest purity possible as a priority,” added Thomas LeJolly, Asia Pacific director at Polyplus. “From there we will work to optimize all critical upstream raw materials to achieve highest yields and lower cost per dose for patients.”
Throughout this collaboration, the teams will also build and share local knowledge to help create a wider exchange of information and expertise to advance CGT manufacturing, according to officials at both companies.