#United States #Houston #Syenex #Bionova Scientific #Plasmid DNA

Bionova Scientific Partners with Syenex for Strategic Alliance

Bionova Scientific LLC, a company under the Asahi Kasei umbrella, announces an important strategic alliance with Syenex, a pioneering firm in the genetic medicines space. The collaboration aims to broaden access to critical plasmid DNA (pDNA), which is vital for the development of next-generation therapies targeting genes and cells.

This partnership consolidates Bionova's position as a leading manufacturer of plasmid DNA, a crucial building block utilized not only for gene delivery but also for the production of lentiviral vectors essential in cell and gene therapy applications. The alliance seeks to overcome persistent challenges in these fast-evolving therapies, particularly around pricing, quality assurance, and reliability in supply chains for pDNA production.

Bionova’s Advanced Manufacturing Capability

At the core of Bionova’s robust plasmid DNA platform lies a proprietary cell line engineered for stability. These specialized cell lines are designed to eliminate potential contaminants such as insertion sequence elements, cryptic prophages, and unnecessary bacterial genomic regions. This technology minimizes the risks of plasmid rearrangements and genetic instability, ensuring consistent yields in lentiviral vector production.

Bionova’s advanced manufacturing processes focus on producing high-titer, high-purity plasmid DNA. This capability guarantees that the resultant plasmids are suitable across all genetic medicine formats, which include production for lentiviral vectors and also as DNA templates in mRNA manufacturing approaches.

Collaboration Highlights

As part of the agreement, Bionova will serve as the primary manufacturing partner for the exceptional delivery platforms developed by Syenex. Additionally, Bionova will diversify its offerings in both ready-to-use and customized lentiviral vector plasmid systems. This includes systems like gag/pol, rev, VSV-G, and various transgene backbones, catering to different regulatory needs from research use to good manufacturing practices (GMP).

This collaboration allows swift initiation of programs utilizing readily available plasmids, ensuring a smooth transition to GMP standards without the need to change plasmid systems, which mitigates risks associated with comparability during various stages such as IND-enabling, clinical, or late-stage programs.

With this integrated framework, developers gain the flexibility to optimize plasmid systems throughout clinical phases using structured comparability strategies. This not only reinforces the manufacturability of lentiviral vectors but also enhances their functional performance.

Future Directions

Darren Head, President of Bionova Scientific, emphasized the significance of this alliance. “Our mission has always been to provide specialized DNA solutions to the cell and gene therapy landscape. By integrating Syenex's cutting-edge delivery technologies with our manufacturing expertise, we're not only fortifying the lentiviral vector systems in use today but also positioning our clients for smoother transitions toward innovative approaches such as in-vivo lentiviral vector applications. This, in turn, promotes operational excellence and accelerates the path toward commercial production,” he remarked.

Echoing these sentiments, Jay Rosanelli, CEO and Co-Founder of Syenex, stated, “Our collaboration with Bionova enables us to bring our scalable delivery systems directly to developers of therapies, facilitated through a highly trusted and quality-focused CDMO. Through this partnership, we aim to provide a distinct and scalable solution that minimizes risks during development, boosts manufacturability, and supports therapy developers in advancing their initiatives.”

This strategic alignment signifies a critical advancement in high-yield, quality-driven plasmid DNA manufacturing, laying the groundwork for the future of cell and gene therapies. Such initiatives are essential as the demand for reliable and innovative therapies continues to grow within the medical field, aiming to transform health outcomes for many patients worldwide.

About the Companies

Bionova Scientific operates with a profound understanding of complex biologics, offering customized solutions designed to advance biotherapeutic innovations from the early stages of development to market readiness. Their facilities in Fremont, California, and The Woodlands, Texas, focus on delivering high-quality manufacturing tailored to the specifics of each client’s requirements.

Syenex, founded in 2022, specializes in an open-science framework enabling precise programming of cells at a large scale. They harness synthetic biology along with a worldwide network of CDMOs to facilitate rapid progression of genetic medicines from discovery to clinical phases. By creating partnerships that span across biopharma and academic sectors, Syenex continues to lead in advancing genetic medicine solutions.