BIA Separations & RBPS agree on supporting clinical-stage production of Minicircle DNA

Biochromatography development and manufacturing company, BIA Separations, and biotech company, RBPS Technology, have signed a partnership agreement to support the clinical-stage production of high purity Minicircle DNA for viral and non-viral gene transfer.

This partnership combines BIA Separations’ monolithic purification tools with RBPS’ novel process for production of Minicircle DNA — plasmid DNA with an optimised safety profile for application in gene therapy.

“Clinical scale availability of high purity Minicircle DNA has previously been a major challenge to its adoption, due to issues with production efficiency. Monoliths are a well-established purification tool for DNA plasmids, and we are pleased to now adapt the technology to the specific requirements of Minicircle DNA,” commented Aleš Štrancar, CEO of BIA Separations. “We believe the RBPS System has huge potential for DNA vaccines and gene therapies, both for non-viral and viral gene transfer. This will only be fully realized through robust and scalable production.”

“We anticipate that our collaboration with BIA Separations will help accelerate the clinical evolution of DNA Minicircles for widespread use in the clinical field, for non-viral gene transfer,” said Dr Peter Mayrhofer, inventor of the RBPS System and CEO at RBPS Technology. “Over the last decade non-viral approaches have consistently contributed 20–25% each year to the total number of clinical gene therapy trials. Added to which, there is a growing market for DNA vaccines with high demand for safe and efficient vector systems suitable for human as well as for veterinary applications. I am therefore confident we are entering an exciting period for Minicircles, and with our unique production process we will be able to support customers with both quantity and quality.”