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BIA Separations partners with RBPS Technology to provide large scale Minicircle DNA vector production

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

Ajdovščina, Slovenia and Vienna, Austria, 21 March 2018: BIA Separations, a leading biochromatography development and manufacturing company, and RBPS Technology (RBPS), a biotech company with proprietary Minicircle DNA technology, today announced 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 Ales Strancar, 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.”

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 RBPS Technology Peter Mayrhofer CEO E: This email address is being protected from spambots. You need JavaScript enabled to view it. T: +43 (0)676 3475380

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