Combined Production Methods Achieve High Recovery Rates

Biochromatography development and manufacturing company BIA Separations and Biomay, a contact manufacturer of cGMP biopharmaceuticals, are collaborating on the high-yield production of large DNA plasmids - larger than 20,000 base pairs (20kbp )- to achieve high recovery of 95% supercoiled DNA. The new manufacturing process addresses a major challenge in the scaled manufacture of plasmid DNA and represents a significant step towards the wide application of large DNA plasmids in cell and gene therapy.

The collaboration combines Biomay’s experience in the production of GMP-conform ultrapure pDNA with BIA Separations’ CIM® monolithic chromatographic columns. Monoliths support effective purification for plasmids up to at least 60 kbp and are able to maintain high capacity and resolution at high flow rates regardless of the size of the molecules being separated., the company said.

The system is commercially available to clients through Biomay´s GMP service offerings.

Aleš Štrancar, CEO of BIA Separations commented: “Monoliths have been well-established for some time as the best purification tools for smaller single-gene plasmids and we are pleased to now adapt them to the purification of larger pDNA molecules. By working with Biomay, we are removing a major obstacle in the field which will allow product developers to proceed with an unlimited array of multi-gene clinical candidates.”

Dr Hans Huber, COO of Biomay added: “The combination of our know-how in pDNA production with BIA’s monolithic columns represent a key enabling step for us to meet our customer´s needs for fast and economic production of large DNA plasmids, such as AAV starting vectors, in quantities required for the clinical development and early market supply of their gene therapy products.”