Bionova Scientific, a biologics contract development and manufacturing organization (CDMO), has appointed Bionique Testing Laboratories as its preferred provider for mycoplasma testing services in biologics manufacturing. This strategic partnership aims to enhance safety and improve efficiency in biotherapeutic manufacturing processes.
The collaboration represents a significant step in Asahi Kasei Medical's vision to create an integrated supply chain by bringing together specialized providers in the biologics manufacturing ecosystem. "The collaboration between Bionova and Bionique represents the realization of Asahi Kasei Medical's vision of bringing together best-in-class providers to create an integrated supply chain that enhances safety and improves the efficiency of biotherapeutic manufacturing," said Yusuke Kanazawa, Head of the Asahi Kasei Bioprocess division.
Expansion of Testing Capabilities
This partnership follows Bionique Testing Laboratories' significant expansion announcement last year. The company broke ground in March 2024 on an additional facility spanning approximately 35,000 square feet, which includes about 16,000 square feet dedicated to laboratory support space. The expanded facility is expected to be completed in early 2025, substantially increasing Bionique's testing capacity.
Bionique Testing Laboratories brings over 30 years of experience in biologics testing, offering comprehensive mycoplasma testing methods ranging from compendial to novel rapid molecular approaches. "When it comes to defining a successful release testing strategy for mycoplasma, they are the authority in the field," noted Darren Head, Chairman of Bionova Scientific.
Strategic Alignment with Asahi Kasei's Healthcare Vision
The collaboration aligns with Asahi Kasei's Medium-Term Management Plan announced in May 2024, which emphasized the strategic importance of its Bioprocess division within the company's broader healthcare strategy. Having acquired Bionova Scientific in 2022, this partnership further demonstrates Asahi Kasei's commitment to strengthening its bioprocess capabilities.
In April 2024, Asahi Kasei established Asahi Kasei Life Science to operate its bioprocess businesses under a new organizational structure. This restructuring brings together several bioprocess-related business units, including virus removal filters Planova™, testing services from ViruSure and Bionique Testing Laboratories, and CDMO services from Bionova Scientific.
"We are very excited to support Bionova Scientific with the release testing of biologics by providing cutting-edge, dependable, and efficient testing solutions through this collaboration," said Gladis Zamparo, CEO of Bionique Testing Laboratories. "Bionova's mantra has been to build the top scientific services to push the boundaries of bioproductivity, and the integration with Bionique further reinforces their stance."
Expanding Bioprocess Portfolio
Asahi Kasei Life Science covers a broad range of bioprocess products and services, contributing to improved safety and productivity for antibody drugs, plasma derivatives, and nucleic acid drugs. The company has been actively expanding its production and service capabilities for bioprocess-related businesses in recent years.
In 2023, Asahi Kasei scaled its facility in Glenview, Illinois, to enhance innovation and meet growing market needs for fluid management equipment and virus filtration technology. In 2024, a new assembly plant for Planova™ was completed in Nobeoka, Miyazaki, Japan, to ensure stable supply in response to increasing global demand.
Furthermore, Asahi Kasei is launching a plasmid DNA business under Bionova and establishing a new pDNA facility in Texas, focusing on providing solutions for emerging modalities such as cell and gene therapy.
Industry Impact and Future Outlook
The partnership between Bionova Scientific and Bionique Testing Laboratories represents a significant development in the biologics manufacturing landscape, potentially setting new standards for quality control and safety testing in the industry.
"I am thrilled to announce the start of operations at Asahi Kasei Life Science, which began on April 1," said Ken Shinomiya, President of Asahi Kasei Life Science. "Focused on the field of life science centered on the bioprocess business, we aim to expand as part of the growing Healthcare sector business, the main growth driver of the Asahi Kasei Group. As a trusted premium partner, we are dedicated to shaping the future of the pharmaceutical industry—delivering innovative, reliable solutions that drive lasting impact and empower our clients to thrive."
As the biopharmaceutical industry continues to evolve with increasingly complex modalities and manufacturing processes, integrated solutions that enhance safety, quality, and efficiency become increasingly valuable. This collaboration positions both companies to better serve the growing needs of the biologics manufacturing sector while advancing Asahi Kasei's strategic vision in healthcare.
