In Vitro Diagnostics Contract Manufacturing Services | Custom Assay Development

Service Capabilities

Bio-Techne is a proven leader in the IVD industry, providing the broad expanse of tools, knowledge, and guidance you need to solve complex challenges and improve lab diagnostics. Our services include:

Custom Controls & Calibrators
Assay Development
IVD Manufacturing
Technology Transfer
Packaging Development
Regulatory Support
Technical Support
Stability Programs

Bio-Techne has an extensive library of recombinant antigens and antibodies to help you compress your development cycle.

Manufacturing Capabilities

Whether you’re a pre-commercial startup that needs a custom formulation or a multinational looking to outsource manufacturing, we can help accelerate your business. We offer this expertise in partnership, acting as an extension of your organization by learning your requirements and delivering the right solution.

Liquid Formulation/Filling
Powder Formulation
Powder Blending and Filling
Reagent Tablets
Lyophilization
Off-line/In-line Labeling
Kit Assembly/Packaging
Final Product Testing

The process has three phases – proof-of-concept phase, development/optimization phase, scale-up and technical transfer phase.

Benefits of OEM Contract Manufacturing

Access specialized equipment and technology for efficient and high-quality production
Reduce capital expenditure on manufacturing facilities and equipment
Increase production capacity and scalability
Improve cost-effectiveness and efficiency
Reduce time-to-market for new products

Product transfer specialists - We minimize the pain of changing vendors, using an established framework to simplify product transfers and ensure a smooth transition.

Custom solutions - We take the time to learn your unique requirements and give you the right solution.

Quality & Regulatory – We design and manufacture products to meet the exacting requirements of our customers to meet global regulatory requirements.