#United States #biopharmaceuticals #Asahi Kasei #Bionique Testing #Saranac Lake

Bionique Testing Laboratories Expands Operations

In a significant move to bolster the drug development landscape, Bionique Testing Laboratories LLC, a noted subsidiary of Asahi Kasei, has officially opened a new facility which includes 35,000 square feet of state-of-the-art laboratory and support spaces. This expansion marks a pivotal milestone for Bionique as it elevates its service capabilities to meet the growing demands of the life sciences industry.

The grand opening event, held on September 26, 2025, showcased the newly built premises in Saranac Lake, New York. With this expansion, Bionique aims to amplify its effectiveness in providing comprehensive biosafety testing as well as validation services crucial to the drug development lifecycle. Present at the event were key leaders from the industry, emphasizing the importance of this development for future drug testing and safety procedures.

Purpose-Built Facilities

The new facility triples the size of Bionique's original establishment, enhancing the lab's capabilities significantly. Designed with targeted laboratories for mycoplasma, sterility, endotoxin, and viral testing, the new space incorporates flexible containment labs and BSL capabilities tailored for diverse modalities including biologics, cell and gene therapies, and advanced therapeutics. This meticulous project realigns with Bionique’s objective to maintain high standards while responding to evolving regulatory requirements and industry needs.

Gladis Zamparo, CEO of Bionique, remarked, "This facility investment is about an expanded service offering. For decades, customers have trusted Bionique for critical lot-release testing. Our expansion ensures we broaden our capabilities and digital experience, while maintaining accelerated turnaround times—allowing our partners to release safe products faster."

Responding to Industry Needs

The timing of this expansion is particularly critical as the industry is facing a substantial transformation. Lori Daane, PhD., the Chief Scientific Officer at Bionique, stated, "As global regulations evolve to enable broader adoption of rapid testing methods for mycoplasma and sterility, our decades of scientific rigor, method development, and quality systems provide a clear path to implementation without compromising compliance."

With international standards shifting towards a greater acceptance of rapid biosafety analytical testing solutions, Bionique's enhanced infrastructure is well-positioned to lead in this domain. The integration of advanced technologies within the testing processes enables a swift response to the changing regulatory landscape and industry demands.

Additionally, the collaboration between Bionique and ViruSure, a Vienna-based Contract Research Organization specializing in viral services, has created a robust biosafety service offering. This partnership is pivotal for advancing the safety and reliability of biopharmaceutical products across various therapeutic modalities, thereby creating additional value for a diverse range of stakeholders.

A Bright Future Ahead

Andy Bailey, CEO of ViruSure and the Biosafety Testing Division at Asahi Kasei Bioprocess, highlighted that "This expansion allows Bionique to broaden its analytical portfolio, aligning with our strategy to invest in solutions for the life sciences industry with long-term growth potential."

As Bionique embarks on this next chapter, the laboratory is committed to supporting its clients on a global scale. By enhancing its testing capabilities, Bionique seeks to continue delivering significant contributions to the development and testing of biopharmaceuticals, cell and gene therapies, and vaccines.

To discover more about the cutting-edge technology and extensive capabilities offered by Bionique Testing Laboratories, be sure to visit their website at Bionique. The future looks promising for this innovative organization as it positions itself at the forefront of the biopharmaceutical testing industry.

About Bionique Testing Laboratories

With over 35 years of expertise, Bionique Testing Laboratories remains a leader in mycoplasma and biosafety testing within the life sciences sector. Located in Saranac Lake, NY, they provide analytical testing solutions that are essential for ensuring the safety and efficacy of biopharmaceuticals, cell and gene therapies, and vaccines. Bionique plays a crucial role within Asahi Kasei's Biosafety Testing Services Unit, continuously striving for excellence in their field.

About Asahi Kasei

The Asahi Kasei Group, founded in 1922, is committed to enhancing the quality of living globally. With a workforce exceeding 50,000, Asahi Kasei delivers sustainable solutions across its main sectors: Material, Homes, and Health Care.