Saturday, June 22, 2024

Manufacturing Expansion: Bionova Enters Plasmid DNA Production for Cell and Gene Therapies

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As Japanese chemical giant Asahi Kasei continues to expand into the biopharma contract manufacturing sector, its biologics CDMO, Bionova Scientific, is broadening its services to include starting materials for innovative medicines such as cell and gene therapies. Asahi’s U.S. subsidiary, Bionova Scientific, announced on Monday the launch of a new business line focused on providing services around plasmid DNA (pDNA). This strategic expansion aims to support the growing demand for high-quality pDNA, a critical component in the production of cell and gene therapies, mRNA vaccines, and antibody drugs.

In alignment with this strategic shift, Bionova is establishing a new facility in The Woodlands, Texas, near Houston. Development work and research-grade pDNA production are set to begin in the first quarter of 2025, followed by GMP (Good Manufacturing Practice) manufacturing later in the same year. The new facility will enhance Bionova’s ability to meet the stringent regulatory requirements and high-quality standards needed for the production of innovative therapeutics.

Financial details about the new facility and production focus were not disclosed. However, the investment underscores Bionova’s commitment to expanding its capabilities and addressing the needs of the rapidly growing cell and gene therapy market. Plasmids—DNA molecules found in microorganisms like E. coli—are increasingly being used as starting materials for medicines. Bionova predicts the pDNA market will grow at double-digit rates over the next several years. The company attributes this anticipated growth to the “persistent unmet need” for high-quality, reliable pDNA supply among developers of new cell and gene therapies (CGT).

Bionova Expands Manufacturing in Texas to Tap into Biotech Growth

Bionova is setting up its operations in Texas to leverage the state’s “rapidly expanding CGT ecosystem.” Texas has become a hub for biotechnology and life sciences, offering a supportive environment for innovative research and development. By establishing a presence in this dynamic region, Bionova aims to collaborate with local researchers, academic institutions, and biotech companies to advance the development of cutting-edge therapies.

Currently, Bionova is known for its work-in-process development of next-generation antibody-based drugs that are difficult to produce. These efforts have established Bionova as a reputable player in the biopharma industry. Asahi Kasei completed its acquisition of Bionova in April 2022, enhancing its bioprocess business with CDMO capabilities. The acquisition allowed Asahi Kasei to integrate Bionova’s expertise in biologics manufacturing into its broader portfolio, strengthening its position in the global biopharmaceutical market.

In early 2023, Bionova announced plans to quadruple its existing GMP manufacturing capacity. This ambitious expansion reflects the company’s confidence in the growing demand for its services and its commitment to supporting the production of innovative therapies. Bionova’s new focus on pDNA comes as its parent company, Asahi Kasei, seeks to expand its pharmaceutical business. The Japanese conglomerate has been making strategic moves to enhance its presence in the biopharma sector and diversify its portfolio.

Manufacturing

Asahi Kasei Acquires Calliditas for $1.06B, Boosting Manufacturing and Immunology Expansion

Asahi Kasei made a cash offer to acquire Sweden’s Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion). This acquisition will allow Asahi to gain access to Calliditas’ primary immunoglobulin A nephropathy (IgAN) treatment, Tarpeyo. The deal represents a significant step in Asahi Kasei’s strategy to expand its business into immunology, transplantation, and adjacent diseases, with a particular emphasis on the U.S. market.

Asahi Kasei is one of Japan’s leading industrial companies, with operations spanning chemicals, electronics, pharmaceuticals, medical devices, and more. The company established its U.S. pharmaceutical business in 2020 with the acquisition of Veloxis Pharmaceuticals, marking its entry into the competitive American market.

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Through these strategic expansions and acquisitions, Asahi Kasei aims to leverage its expertise and resources to drive innovation and deliver high-quality solutions to the global healthcare industry. The company’s ongoing investments in biopharma and commitment to regulatory excellence underscore its dedication to improving patient outcomes and addressing unmet medical needs worldwide.

 

Resource: Bionova Scientific, June 03, 2024

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