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Collaboration supports clinical-scale production of high purity Minicircle DNA for viral and non-viral gene transfer

BIA Separations, a leading biochromatography development and manufacturing company, and RBPS Technology (RBPS), a biotech company with proprietary Minicircle DNA technology, announce they have signed a partnership agreement to provide scalable manufacture of Minicircle DNA at high purity. The project combines BIA Separations’ monolithic purification tools with RBPS’ novel process for production of Minicircle DNA - plasmid DNA with an optimized safety profile for application in gene delivery.

Safety continues to be a critical issue with the use of bacterial DNA sequences in plasmids intended for clinical applications. Minicircles are circular, covalently closed DNA units lacking plasmid-typical ‘backbone’ sequences, such as a bacterial replication origin or an antibiotic resistance marker. The smaller size of Minicircles also extends cloning capacity and facilitates their delivery into cells. Minicircle DNA is therefore considered to be the safest and most efficient vector for gene transfer. The RBPS system removes the bacterial backbone sequences from producer plasmids with more than 99.5% efficiency.

“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.”

Dr Peter Mayrhofer, inventor of the RBPS System and CEO at RBPS Technology, said: “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. 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.”