News

Bionique Appoints Dr. Andy Bailey as new President and Chief Executive Officer

Saranac Lake, New York – January 28, 2026 – Bionique Testing Laboratories (Bionique), a subsidiary of Asahi Kasei and a globally recognized specialist in mycoplasma and biosafety testing services for the life science industry, today announced the appointment of Andy Bailey, PhD, as President and Chief Executive Officer, effective April 1, 2026. Bailey brings more than 30 years of experience in the safety of biological products, including viruses, prions, and mycoplasmas. The leadership change positions Bionique to fully leverage its expanded facility and accelerate future growth across biosafety testing services.  

Bionique Testing Laboratories Strengthens Operations with ~35,000 Sq Ft Expansion to Further Support Drug Development and Demand for Rapid Biosafety Testing Solutions

Saranac Lake, New York – Sept. 30, 2025 – Bionique Testing Laboratories LLC, a subsidiary of Asahi Kasei and a globally recognized mycoplasma testing services specialist for the life science industry, hosted a Grand Opening Ceremony on September 26th to commemorate the completion of its newly expanded facility.

Bionique Testing Laboratories and Cellipont Bioservices Partner to Accelerate Adoption of Rapid Mycoplasma Testing in Cell and Gene Therapy Manufacturing

The Woodlands, Texas and Saranac Lake, New York – May 29, 2025 – Bionique Testing Laboratories, a global leader in mycoplasma testing services and part of the Asahi Kasei group, and Cellipont Bioservices, a premier Contract Development and Manufacturing Organization (CDMO) specializing in cell therapies, announce a strategic partnership to advance the adoption and validation of rapid mycoplasma detection methods in support of cGMP manufacturing for cell and gene therapies.

FDA Approves Abeona Therapeutics’ First Autologous Cell-Based Gene Therapy

Bionique congratulates Abeona Therapeutics on their recent FDA approval for Zevaskyn™ as the first autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. Bionique is proud of having contributed to Abeona’s application process by performing mycoplasma comparability services.

Bionova Scientific Appoints Bionique Testing Laboratories as Preferred Provider for Mycoplasma Testing Services for Biologics Manufacturing

Fremont, California and Saranac Lake, New York – March 20, 2025 – 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.

bioMérieux and Bionique Testing Laboratories Announce Collaboration to Enhance Mycoplasma Testing Solutions

Saranac Lake, NY – September 16, 2024—Bionique Testing Laboratories LLC, a global provider of mycoplasma testing services and bioMérieux, a world leader in the field of in vitro diagnostics, , announced today that they are joining forces to provide bioMérieux’s valued customers direct access to Bionique’s product-specific validation services for the BIOFIRE® FILMARRAY® 2.0 Industry system for mycoplasma detection to facilitate the efficient validation and implementation of the technology, and support the clinical development of biologics including cell & gene therapies.

Bionique Holds Groundbreaking Ceremony for Building Expansion

The groundbreaking ceremony held on May 14, 2024 marks a significant investment in Bionique’s continued growth and commitment to progress. The project will enable the company to expand its biosafety testing services to better serve clients and further support the discovery and development of biologics.

Bionique Welcomes New Member to Leadership Team

Lori Daane, PhD joins Bionique as its new CSO effective April 1, 2024. She has over thirty years of experience and is uniquely positioned to lead Bionique’s service portfolio expansion, enabling the organization to solve for the biosafety testing needs associated with the development, manufacturing, and release of biologics inclusive of cell & gene therapies.

Bionique Receives Asahi Kasei Bioprocess Division Award

Bionique is excited to announce that its team received the 2023 Asahi Kasei Bioprocess Division Award. This award recognizes innovation and outstanding achievement. Congratulations to Kevin Susice, Eric Damour, Brandy VanBuskirk, and Doug Crowell for their remarkable contributions to introducing automation in testing!

Bionique to Expand After Acquisition by Asahi Kasei Medical

On December 15, 2021, Bionique announced it has been acquired by a subsidiary of Japan-based healthcare pioneer Asahi Kasei Medical Co., Ltd. Bionique joins Austria-based viral and prion safety testing services expert ViruSure GmbH as part of the global biosafety testing services unit of Asahi Kasei Medical’s Bioprocess Division. Both Bionique and ViruSure will continue operations under their existing, widely respected brands.

Bionique in Association with ThermoFisher and American Pharmaceutical Review Present: Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection.

This white paper explains the importance of demonstrating product-specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence. Rapid microbial methods are increasingly being used by cell therapy developers motivated by particularly short production schedules and product shelf life, and has grown to include raw material providers interested in reducing inventory hold times.

Bionique’s Research Presented in Advances in Biotechnology & Microbiology

Research conducted at Bionique Testing Laboratories was published in an article that studies the impact of aerobicity on colony growth of various mollicutes, including mycoplasma, on agar in order to confirm the optimal oxygen content for colony growth for isolation of mycoplasma from cell cultures for routine subcultivation. The purpose of the study was to continue to be an industry leader and address a lack of information pertaining to the impact of atmospheric testing conditions, aerobic or anaerobic, compared to the industries common standards and good practices.