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BIA Separations and Biomay collaborate on production and purification of large DNA plasmids

Collaboration enables high yield, high purity supercoiled plasmid DNA manufacture for therapeutic application

Ajdovščina, Slovenia and Vienna, Austria, 16 May 2018: BIA Separations, a leading biochromatography development and manufacturing company, and Biomay, a contact manufacturer of cGMP biopharmaceuticals, today announced a collaboration on the high-yield production of large DNA plasmids. The companies have co-developed an economical production system for double-digit gram-scale production and purification of plasmids larger than 20,000 base pairs (20kbp) achieving 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® (Convective Interaction Media) 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 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.”

At BIA Separations E: This email address is being protected from spambots. You need JavaScript enabled to view it. T: +386 (0)59 699 505

Media contact Sarah Jeffery (Zyme Communications) E: This email address is being protected from spambots. You need JavaScript enabled to view it. T: +44 (0)7771 730 919

At Biomay: E: This email address is being protected from spambots. You need JavaScript enabled to view it. T:+43 1 7966296 100

BIA Separations and Nuvonis Technologies partner to support vaccine and gene therapy production

Agreement combines strengths in upstream and downstream process development.

BIA Separations, a leading biochromatography development and manufacturing company, and Nuvonis Technologies (Nuvonis), a biotech company providing innovative production cell banks, today announced they have signed a partnership agreement. The companies will offer solutions to meet the growing demand for vaccine and gene therapy production, and tackle the technical challenges associated with managing the upstream/downstream process interface.

The partnership agreement will provide customers with an offering that combines Nuvonis’ unique Vero cell bank with BIA Separation’s CIM monolithic column purification products, along with both companies’ deep understanding for upstream and downstream process development. The companies will work with customers to create targeted solutions to improve manufacturing process execution, for the development of manufacturing procedures for gene therapy, oncolytic vaccines, exosomes and similar biomolecules. The integrated offering will significantly reduce costs, by providing a single source of expertise and reducing redundancy in process development.

Aleš Štrancar, CEO of BIA Separations, commented: “The interface between upstream and downstream bioprocessing is one of the most challenging technical areas remaining in the field, and where most production problems arise. I look forward to seeing our teams working together to bring effective solutions to clients of any size – small, medium and large.”

Josef Poandl, Chairman of Nuvonis Technologies’ board, said: “Choosing a well characterized Vero cell substrate and designing a simple high yield purification process is an important strategic element to most vaccine and gene therapy companies. By working together with BIA Separations, we will be able to offer unique solutions to improve production.”