Bionova Appoints Bionique as Preferred Provider for Mycoplasma Testing

US CDMO, Bionova Scientific, has selected New York CRO, Bionique Testing Laboratories, as its preferred provider for mycoplasma testing services in biologics manufacturing. The appointment will allow enhanced quality control processes for biologics production, ensuring the safety and efficacy of therapeutic products.

Bionique’s expertise in mycoplasma detection and testing will help Bionova’s clients meet regulatory requirements and mitigate risks associated with contamination, thus strengthening its services for biologics manufacturers.

The following article originally appeared in PR Newswire.

Bionova Scientific, a boutique commercial-scale biologics contract development and manufacturing organization (CDMO), announced that Bionique Testing Laboratories, a leading Contract Research Organization (CRO), has been appointed as the preferred provider for mycoplasma testing services supporting the efficient manufacturing of biologics. Both are subsidiaries of the global Japanese conglomerate Asahi Kasei Corporation's medical division.

"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.

This collaboration follows Bionique Testing Laboratories' expansion announcement last year. The company broke ground in March 2024 on an additional ~35,000 sq. ft. facility space, including ~16,000 sq. ft. of laboratory support space. Completion is expected in early 2025.

"With over 30 years of experience, Bionique has unparalleled expertise in the testing of biologics inclusive of offering the full range of mycoplasma testing methods, from compendial to the novel rapid molecular, as well as having a deep understanding of the CMC testing requirements. When it comes to defining a successful release testing strategy for mycoplasma, they are the authority in the field," says Darren Head, Chairman of Bionova Scientific.

Asahi Kasei's Medium-Term Management Plan, announced in May 2024, emphasized the role of Bioprocess within the company's larger healthcare strategy. Having acquired Bionova Scientific in 2022, this latest collaboration exemplifies Asahi Kasei's commitment to more broadly strengthening the bioprocess division and healthcare.

"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."

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