#USA #Fremont, California #Asahi Kasei #Bionova Scientific #Bionique Testing

Bionova Scientific Partners with Bionique Testing Laboratories for Enhanced Mycoplasma Testing

In a significant development for the biologics manufacturing industry, Bionova Scientific has announced a partnership with Bionique Testing Laboratories to become the preferred provider of mycoplasma testing services. This collaboration aims to streamline the manufacturing process and boost efficiency in the production of biologics, ensuring that these essential therapies meet stringent safety standards.

Both organizations are subsidiaries of the Asahi Kasei Corporation, a well-known conglomerate operating globally in various sectors, including healthcare. Yusuke Kanazawa, the Head of Asahi Kasei’s Bioprocess division, commented on the collaboration, stating that it embodies the company's vision to merge top-tier service providers and create a seamless supply chain. This initiative not only enhances the safety of biotherapeutic production but also promotes operational efficiency.

Bionique's Expansion and Expertise

This partnership follows Bionique's announcement regarding its expansion plans last year. In March 2024, Bionique commenced the construction of an additional facility of approximately 35,000 square feet to better accommodate its laboratory services, with completion expected by early 2025. Bionique boasts over three decades of expertise in biologics testing, including a comprehensive suite of mycoplasma testing methods, from traditional compendial approaches to cutting-edge rapid molecular techniques.

Darren Head, Chairman of Bionova Scientific, highlighted Bionique's authority in the realm of mycoplasma testing and its deep knowledge of Chemistry, Manufacturing, and Controls (CMC) testing requirements. These qualities are pivotal when devising effective release testing strategies that uphold the integrity and safety of biologics.

Strengthening Bioprocess Division

This collaboration is aligned with Asahi Kasei's broader healthcare strategy, as outlined in its Medium-Term Management Plan from May 2024. The acquisition of Bionova Scientific in 2022 marked a strategic move to bolster the bioprocess division. With Bionique becoming a key testing partner, Asahi Kasei reaffirms its commitment to enhancing capabilities within the biologics sector, contributing to advancements in healthcare.

Gladis Zamparo, CEO of Bionique Testing Laboratories, expressed enthusiasm about supporting Bionova's testing efforts. She emphasized that Bionique will deliver reliable and innovative testing solutions, further cementing the partnership’s goal to push the limits of bioproductivity in the industry.

Both companies aim to contribute significantly to biopharmaceutical safety and quality control, essential in today's rapidly evolving healthcare environment. The collaboration signals a new era for biologics manufacturing, particularly in mycoplasma testing, which plays a critical role in ensuring the safety and efficacy of therapeutic solutions.

About The Organizations

Bionova Scientific is dedicated to partnering with innovators in the biologic sector. Founded in 2014, the company was acquired by Asahi Kasei in 2022. Bionova specializes in integrated contract development and manufacturing services, including cell line development and cGMP manufacturing of complex proteins and antibodies. Their state-of-the-art facility in the San Francisco Bay Area is equipped to tackle the challenges associated with the transition from discovery to first-in-human trials.

Bionique Testing Laboratories, located in Saranac Lake, NY, excels in providing comprehensive mycoplasma testing and validation services. The organization plays a crucial role in ensuring that biopharmaceuticals, cell, and gene therapies, as well as vaccines, meet rigorous safety and quality standards. As a vital part of Asahi Kasei's Biosafety Testing Services Unit, Bionique is committed to supporting clients in their quality control needs.

Through this collaboration, both Bionova Scientific and Bionique Testing Laboratories are poised to deliver enhanced solutions that will further advance the biotherapeutics landscape.