Diagnostic Development & Manufacturing

With over 50 years of experience, global regulatory registrations, and a strong commitment to quality, IVD manufacturers trust Bio-Techne Diagnostics to bring innovative design, reliable scale, and sustainable supply to every partnership. 

We understand the demands of those who develop and manufacture IVD’s, as well as clinicians that rely on actionable and reliable results, because we develop diagnostic tests ourselves. We apply these insights to help our customers solve complex challenges, advance innovation, and improve patient care worldwide. 

Equally important is our proven ability to manufacture reliably at scale. Operating under cGMP and ISO 13485 quality systems, our global facilities support liquid and dry formulations, high-speed filling, labeling, and kit assembly, with batch capacities up to 1,200 liters and labeling rates of 27,000 units per hour. Ambient and cold-chain logistics ensure global distribution with consistency and confidence. Our manufacturing approach is built on three pillars: seamless product transfers, tailored solutions aligned to assay and platform needs, and unwavering quality and regulatory excellence.