RD-Biotech, a Contract Research Organization (CRO) specializing in the production of plasmid DNA (pDNA) for early-phase clinical trials, has partnered with Pall Corporation to supply single-use solutions and purification technology to support the manufacture of industrially-relevant volumes of GMP-grade pDNA. These support the exponential growth in gene and mRNA-based therapies with demand being accelerated by many of the COVID-19 vaccines and the number of therapeutic opportunities in the drug development pipeline.
“Our new production units will complement our existing production capabilities for R&D and ‘High-Quality’ grade plasmids. There is high demand for pDNA and we are already in discussion with several clients eager to access our manufacturing capacity.” said Dr Jean-Luc Schlick, Vice President GMP Plasmid Biomanufacturing at RD-Biotech. “Many of the challenges associated with this scale of GMP production were new to us, but Pall quickly helped to ensure that the detailed process designs required to support our manufacturing plans were in place. Pall allowed us to visualize our future manufacturing facility and helped ensure the technology changes required to support the increased scale of production were fully tested and proven to achieve the desired quality of product.” “The level of this new plasmid production unit is the best of class and will help our customers to accelerate their clinical trials and come faster to the market.”
“Pall Corporation understands the enormous potential of gene and mRNA-based therapies and is proud to support RD-Biotech and the increase in pDNA capacity to support this industry growth” said Clive Glover, General Manager of Pall’s Gene Therapy business. “Our experience in the industrialization of gene and mRNA therapies, coupled with our broad portfolio and process toolbox, helps clients like RD-Biotech realize their manufacturing goals quickly while controlling the risks that can often be associated with rapid growth.”
RD-Biotech’s new facility is optimized to make the production process as cost-effective as possible while also preparing for future expansion as needed. This initial order, including single-use solutions for chromatography and tangential flow filtration, totals >$1M and will support the first 15 production batches. The facility is scheduled to be fully operational in 2023.