Highly complementary transaction will strengthen company’s ability to support bioanalytical services across all stages, development capabilities and geographies

Durham, NC, August 16, 2021 – BioAgilytix Labs, LLC (BioAgilytix), a leading global contract research laboratory focused on supporting its pharmaceutical and biotech partners in all stages of large molecule drug development, announced today that it signed a definitive agreement to purchase 360biolabs^®, the most comprehensive contract research organization in Australia. The transaction will expand BioAgilytix’s global footprint into a jurisdiction of choice to commence first-in-human trials (FIH) and early-phase clinical trials and adds further capacity by joining 360biolabs’ internationally recognised Quality systems (ISO/IEC 17025, ISO 15189, GLP and GCLP) in Melbourne, Victoria with BioAgilytix’s existing laboratories in Durham, North Carolina; Boston, Massachusetts; and Hamburg, Germany.

Located in Australia’s biomedical and clinical research hub, 360biolabs offers world-class virology and immunology expertise, with BSL 2 and 3 laboratories, biomarker and immune monitoring capabilities with a state-of-the-art flow cytometry suite, molecular biology PCR suite and expansive bioanalytical LC-MS/MS small molecule capabilities.

“This planned acquisition is part of our strategic growth strategy to expand our capacity, expertise and agility to serve customers across all geographies, and we look forward to welcoming the 360biolabs team and integrating the business,” said Jim Datin, President and CEO of BioAgilytix. “Joining forces makes sense for our two organizations, but most importantly for our combined clients and the patients they serve. BioAgilytix and 360biolabs are already culturally aligned in our focus on doing science right, on time, the first time. Together, we will not only create significant scientific synergies but also generate new innovations and help bring future life-changing therapeutics to patients more rapidly around the globe.”   

“From the launch of 360biolabs in 2015, our strategic vision was to build a global specialty laboratory, providing support to enable future medicines for human health,” said Angela Luttick, 360biolabs Cofounder and Executive Vice President, Business Development. Added 360biolabs Cofounder and CEO Alistair Draffan, “Finding a like-minded partner, driven by a team-focused culture of excellence with an international reputation, US and European presence, will drive our strategic expansion and support our clients’ clinical development programs.” Melinda Pryor, Cofounder and Executive Vice President, Clinical stated, “We’re excited to join forces with the BioAgilytix team, a company that shares our strong scientific track record and commitment to quality and service. Together, we have the capabilities and capacity to meet all challenges, especially in this time of pandemic, and create enduring opportunities for a brighter future.”

The Burnet Institute, a global medical research and public health organisation, is a Cofounder and majority shareholder of 360biolabs. Burnet Institute Director and CEO, Professor Brendan Crabb AC said, “Burnet Institute is proud of its involvement in the foundation of 360biolabs. It is the right time, with the growing need for high quality clinical trial support, for a company of the scale, capability, and reputation of 360biolabs to join with BioAgilytix and expand their capacity to service their customers and facilitate high quality translational medical research.”

The acquisition is subject to Australian Foreign Investment Review Board (“FIRB”) requirements and, subject to receipt of FIRB approval, is expected to close in the third quarter of 2021. BioAgilytix selected White & Case as legal counsel to oversee the closing of the acquisition, with Lazard Australia and Allens representing 360biolabs.

About BioAgilytix

BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle Park, the Cambridge area of Massachusetts, and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states.

BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.). BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies. For more information, visit bioagilytix.com.

About 360biolabs^®
360biolabs^® is the leading and most comprehensive specialty laboratory in the Australia & New Zealand region. Our expert pharmacokinetic (PK) and pharmacodynamic (PD) assay services support small molecule, biologic, vaccine and other innovative therapeutic solutions to human health. A world class and industry experienced technical team, known for their ability to successfully deliver technically challenging assays, 360biolabs^® supports global Pharmaceutical and biotech companies in a diverse and growing range of therapeutics areas.

360biolabs^® delivers global regulatory compliant assays and reports following ISO/IEC 17025, ISO 15189, OECD GLP, GCLP and ICH GCP with a focus on quality. For more information, visit www.360biolabs.com.