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hplc auto-sampler

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 quality control

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.

Additional IVD Capabilities

custom controls & calibrators

Custom Controls & Calibrators

  • Hematology/Flow Cytometry
  • Cardiac Markers
  • Serum Proteins
  • Urinalysis & Urine Chemistry
  • Blood Gas/Electrolytes
  • CO-Oximetry
  • Glucose/Diabetes

Immunoassay Development

Immunoassay Development

  • Assay Design
  • Optimization
  • Validation
  • Commercial Production
  • Support
IVD Raw Materials

IVD Raw Materials

  • Cancer
  • Cardiovascular
  • Drugs
  • Endocrine/Thyroid
  • Serum Proteins
  • Infectious Disease
  • Steroids
  • reKom Biotech

Regulatory & Quality Systems - US FDA, cGMP, IVDR, ISO 13485:2016, 9001:2015, 14001, Health Canada, MDSAP, USDA, US DEA

IVD Contract Manufacturing Request