Press Release: Asahi Kasei Medical Co., Ltd (Asahi Kasei Medical) announced today the acquisition of Bionique Testing Laboratories LLC (Bionique; www.bionique.com), a US-based leader in mycoplasma testing services for the biologics and life-sciences industries.

Bionique joins ViruSure GmbH (ViruSure; www.virusure.com) as part of the global biosafety testing services unit of Asahi Kasei Medical’s Bioprocess Division (www.ak-bio.com). Both Bionique and ViruSure will continue operations under their existing, widely respected brands.

The acquisition brings together the unique mycoplasma and viral safety proficiencies of ViruSure and Bionique, enabling Asahi Kasei Medical to offer clients expansive and exceptionally reliable biosafety testing support that is based on industry-leading scientific expertise, and is delivered via customized, trustworthy project partnerships. Asahi Kasei Medical is also actively investing in the Bionique facilities in Saranac Lake, NY, USA and employment expansion at the operating sites of both Bionique and ViruSure, to meet increasing demand for its testing services.

“We are excited to have a strategic partner like Bionique as part of the Asahi Kasei Group, and the expertise in mycoplasma testing that they bring will further strengthen our goal to better service our customers in all areas of biosafety testing” said Andy Bailey, CEO of ViruSure.

 

About ViruSure GmbH

ViruSure is an established CRO offering a wide range of services in the areas of virus and prion safety testing for biopharmaceutical products, cell banking and cell bank characterization services and in vivo biosafety studies (adventitious agent testing, tumorigenicity testing, oncogenicity testing) and molecular and potency testing, all required by pharma and biotech companies specializing on biological products (e.g. recombinant proteins, vaccines, human and animal derived biological products, cell based therapies). The company brings a wealth and breadth of expertise to ensure that biopharmaceutical companies meet all relevant pathogen safety testing requirements. Our goal is simple – to offer the highest level of quality, customer service and regulatory compliance for pathogen safety testing. Our state-of-the-art facilities located in Vienna, Austria are validated and certified to both GMP and GLP standards and all testing services are supported by a state-of-the-art risk-based quality management system which ensures we remain cutting edge partner dedicated to providing, first and foremost, a quality service to the biopharmaceutical industry. Further information on ViruSure can be found at www.virusure.com.

 

About Bionique Testing Laboratories LLC

Bionique offers the full breadth of mycoplasma testing services from lot to final drug product release testing per regulatory guidelines, as well as a GMP-compliant Real-Time PCR assay to support clients’ needs from discovery to clinical trials. Bionique specializes in mycoplasma testing of cell therapies, cell banks, raw materials, unprocessed bulk harvest, and final drug products. Additionally, our highly experienced team has expertise in method development and validation to support the emerging applications of Rapid Microbial Methods (RMM) and commercialization for biopharmaceutical and cell therapy products. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique’s facilities include two GMP-compliant contract testing and contract R&D laboratories. Bionique aims at offering mycoplasma testing services of unsurpassed quality, to meet the custom scientific and regulatory needs of each client and partner. Further information on Bionique can be found at www.bionique.com.