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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.”

BIA Separations appoints Pete Gagnon as Chief Scientific Officer

Ajdovščina, Slovenia, 17 January 2017: BIA Separations (BIA), a leading biochromatography development and manufacturing company, today announced it has appointed Pete Gagnon as Chief Scientific Officer. In his new role, he will drive the company’s new product and applications development, with a focus on the purification of products for gene therapy, oncolytic vaccines, exosomes and similar, and specifically increasing the safety of these products.

Previously President and CSO of Validated Biosystems, Gagnon assumes his new position with immediate effect. Gagnon has more than 30 years of experience in the biotech industry where he is widely respected for his work in the development of purification technology for the manufacture of biologics, including viruses and exosomes. The majority of his experience has been gained in the development of commercial purification procedures for recombinant human therapeutics. During his career, he has worked with all major chromatography suppliers, supporting the development of new products and applications in line with rapidly evolving industry needs.

Gagnon is the inventor of 20 granted patent families with 20 more pending, and has published more than 80 articles, cited in more than 700 scientific publications, addressing practical aspects of purifying biologics. He has authored a book titled Purification Tools for Monoclonal Antibodies, as well as being invited to contribute chapters to many other books, and sits on numerous scientific and editorial advisory boards.

Aleš Štrancar, CEO of BIA Separations, commented: “Pete’s scientific interests and experience are a perfect fit with our future development strategy and the stringent requirements associated with these classes of products. He has been an influential researcher and a user of BIA’s proprietary CIM® monolith technology for more than a decade, and his enthusiasm, practical skills and insights will make him an invaluable resource for our customers and partners, especially in the fast-developing and challenging fields of virus and exosome purification. This is an area where we expect to see new product lines emerging.”

Pete Gagnon, CSO of BIA Separations added: “I am sincerely delighted to join BIA where I look forward to highlighting the unique abilities of monoliths to elevate product quality, safety, and processing efficiency for some of the most challenging product classes in the field of human therapeutics. Process developers should anticipate the emergence of important and exciting first-in-the-field capabilities by mid-year, and continuing thereafter.”

Pete Gagnon, CSO of BIA Separations

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