Biochromatography development and manufacturing company, BIA Separations, and contract manufacturer of cGMP biopharmaceuticals, Biomay, have announced a collaboration on the high-yield production of large DNA plasmids.
Collaboration
The companies have co-developed a production system that enables double-digit gram-scale production and purification of plasmids larger than 20,000 base pairs. This new process addresses the challenge of scaled manufacture of plasmid DNA.
Through this collaboration, Biomay’s experience in the production of GMP-conform ultrapure pDNA will be combined with CIA Separations’ CIM (Convective Interaction Media) monolithic chromatographic columns.
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.”
The co-developed system is commercially available to customers through Biomay’s GMP service offerings.