Bionique Testing Laboratories Strengthens Operations with ~35,000 Sq Ft Expansion to further support drug development and demand for rapid biosafety testing solutions

The event marks the culmination of a multi-year investment strategy to expand service capabilities through ~35,000 square feet (~3,250 m²) of laboratory and support spaces—more than triple the size of the original ~10,000 square foot (~ 929 m²) facility.  With the state-of-the-art facility expansion, Bionique will be able to deliver comprehensive testing solutions and validation services across the entire drug development lifecycle, focusing on integrating advanced technologies to respond to evolving industry needs and regulatory acceptance of rapid biosafety analytical testing solutions.

"This facility investment is about an expanded service offering," said Gladis Zamparo, CEO at Bionique. "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—so our partners can release safe products faster. "

The new footprint features purpose-built labs designed for mycoplasma, sterility, endotoxin, and viral testing method development and processing. It also includes flexible containment labs and BSL capabilities to meet diverse modality needs across biologics, cell and gene therapies, and advanced therapeutics. The expansion increases capacity for high-volume, CGMP-compliant lot-release workflows with optimized sample logistics and throughput.

"The industry is at a turning point," said Lori Daane, PhD., Chief Scientific Officer. "As global regulations evolve to enable broader adoption of rapid testing methods for mycoplasma and sterility, Bionique's decades of scientific rigor, method development, and quality systems provide a clear path to implementation, without compromising compliance."

As announced in April this year, Bionique remains part of Asahi Kasei's Bioprocess division, which is now under the Asahi Kasei Life Science umbrella. Since 2021, Bionique and ViruSure, a Vienna-based CRO specializing in viral services, have joined forces to provide a comprehensive biosafety service offering.

"This expansion allows Bionique to broaden its analytical portfolio, aligning with Asahi Kasei's strategy to invest in solutions for the life science industry with long-term growth potential," said Andy Bailey, CEO of ViruSure and Head of the Biosafety Testing Division at Asahi Kasei Bioprocess. "By building on Bionique's expertise in microbiological testing as well as ViruSure's expertise in virus safety testing of both traditional and novel therapeutic modalities, we aim to support customers on a global scale, advancing the safety and reliability of biopharmaceutical products across modalities and creating value for our partners and stakeholders."

To learn more about Bionique and its expanded capabilities, visit https://www.bionique.com/.

About Bionique Testing Laboratories:
With over 35 years of experience, Bionique is a leading global Contract Research Organization specializing in mycoplasma and biosafety testing for the life sciences industry. Located in Saranac Lake, NY, Bionique offers analytical testing solutions and validation services to support drug development and ensure the safety of biopharmaceuticals, cell & gene therapies, and vaccines. Bionique is integral to the Biosafety Testing Services Unit of Asahi Kasei Bioprocess. To learn more about Bionique, visit www.bionique.com.

About Asahi Kasei:
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 50,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, and manufacture of biotherapeutics, as well as pharmaceuticals. For more information, visit www.asahi-kasei.com and www.ak-bio.com.

Bionique Testing Laboratories LLC Contact
Ami Parekh
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Bionique Testing Laboratories LLC Customer Inquiries
Ken Lavallee, Director of Sales
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Asahi Kasei Inquiries
Asahi Kasei America
Christian OKeefe
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SOURCE Bionique Testing Laboratories LLC