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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 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.”