BioCina Acquires the Exclusive CDMO Rights for Leading-Edge Minicircle DNA Technology Platform from CelluTx

ADELAIDE, South Australia, June 3, 2024 /PRNewswire/ -- BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organization (CDMO), announced the exclusive rights to utilize CelluTx's Recombination Based Plasmid System (RBPS) technology with BioCina's CDMO clients. RBPS is a cutting-edge technology for minicircle DNA (mcDNA) production involving site-specific recombination within a bacterial host, to separate the minicircle containing the gene of interest from the rest of the plasmid backbone, including the antibiotic resistance genes and origins of replication. This new technology has several advantages over older mcDNA technologies, including process scalability, exceptionally high recombination efficiency, higher yields, simpler purification processes due to the clear separation of minicircles from miniplasmids, and the ability to produce larger minicircles that can accommodate complex gene cassettes. The streamlined structure of the mcDNA leads to enhanced and prolonged transgene expression and makes it less immunogenic and safer for in vivo use. These benefits make RBPS a promising approach for advancing mcDNA production and expanding its potential applications in cell and gene therapies and other advanced therapeutics. An example of such application, announced last year, is the cGMP program that BioCina is currently delivering for GenomeFrontier, in which the RBPS technology is key to the scale-up of GenomeFrontier's CAR-T product.

BioCina's Chief Executive Officer, Mark W. Womack stated, "We are pleased to announce our partnership with CelluTx enabling BioCina to exclusively provide this innovative technology to our clients around the world. We have already witnessed great success in utilizing it within our client portfolio and eagerly anticipate advancing many other client programs with the technology."

CelluTx's Chief Executive Officer, Maurits Geerlings said, "We are very pleased to engage with BioCina for the worldwide deployment of the RBPS minicircle DNA technology. BioCina has proven capabilities and the highest commitment to its customers, which has been fundamental to our partnering with BioCina."

Womack added, "Additionally, Australia offers one of the most attractive Tax Incentives available globally (up to 48.5% cash refund), making it an ideal destination for biologics companies looking to invest in scaling-up and manufacturing their products."

About BioCinaBioCina is a global end-to-end biologics Contract Development and Manufacturing Organisation (CDMO), offering highest-quality, cost-effective cell line, process, analytical and formulation development, and cGMP clinical & commercial manufacturing of the microbial, pDNA and mRNA modalities. BioCina's first facility in Adelaide, South Australia is a testament to the quality of its work. It has a rich history of developing and manufacturing both clinical and commercial drug substance, backed by most critical SME's with an average tenure of 15+ years at the site. BioCina boasts an elite quality record having successfully passed regulatory inspections by the US FDA, Health Canada, and EMA. It is licensed by the Australian TGA for cGMP manufacturing of bulk drug substance or active intermediates. Through a partnership with NovaCina, BioCina offers clients a highest-quality fill-and-finish solution. BioCina is proud to have clients globally, including U.S., Europe, and the Asia Pacific. Because BioCina is not a drug developer, it only serves clients' products. BioCina is establishing a second large-scale, high-capacity end-to-end mammalian and microbial facility in Australia, to be ready for client service in 2026.

Australia offers one of the most attractive tax incentives available globally (up to 48.5% cash refund), making it an ideal destination for biologics companies looking to invest in scaling-up and manufacturing products. Learn more at https://biocina.com.

About CelluTxCelluTx, LLC is a Wayne, PA-based biotech company supporting the cell & gene therapy community through the deployment of the RBPS minicircle DNA Technology invented by Dr. Peter Mayrhofer. The RBPS Technology is designed to provide manufacturing scalability and optimal purity for clinical-grade minicircle DNA. Being devoid of bacterial backbone components, the RBPS Technology provides for safer and more transfection-efficient DNA product, particularly important for CAR-TCR therapies. The RBPS Technology helps optimize various therapeutic application areas where DNA is a critical component, whether it is used as a direct therapeutic, therapeutic intermediate or source for other manufacturing processes. CelluTx has a strategic collaboration with Austria-based Supercoiled Genetics GmbH to support customers at preclinical stage research and development level using the RBPS Technology.

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