IVD Manufacturing

Rapidly scale up production with IVD contract manufacturing from Veracyte

The same proven logistical, regulatory, manufacturing expertise and quality systems that we use to manufacture our own products can handle all or part of your IVD manufacturing needs so you can reach the market quickly and without large-scale capital investments.

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IVD Manufacturing

Mature Quality Environment

Reliable IVD manufacturing only happens with an experienced team and a mature quality environment. At Veracyte, we have both the people and the processes in place to manufacture complex assays and high-quality components.

Products can be developed, manufactured and controlled in compliance with 21 CFR Part 820 & ISO 13485

DSF8020@2x

Full-coverage IVD Manufacturing Capabilities

Manufacturing

  • Positive/Negative control materials
    • Custom plasmids
    • RNA
    • DNA
  • Process control materials
    • Cells in preservative buffer
    • FFPE and TMA controls
  • Purified monoclonal antibodies

QC

  • Quality control process design
  • Process optimisation
  • Incoming QC
  • Finished goods
    • Raw materials QC
    • Semi-finished goods
  • Trending & monitoring
  • Stability studies

Assay & Process Transfer

  • Industrialization of new products (design transfer) or processes
  • Know-how transfer
  • Process and method validation
  • Data center & information storage with secured external access

Supply Chain

  • Short Delivery time
  • Full traceability managed through ERP system
  • Warehouses at -20°C, 4°C & room temperature

>110

Assays

>550

Components

We manufacture a wide range of assays and assay components for biopharma and diagnostics companies around the world.

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Related Services

IVD Development

Streamline in vitro diagnostic (IVD) development by partnering with Veracyte. We offer a full range of services from biomarker discovery and assay development to validation, regulatory submission, and manufacturing from our state-of-the-art facility in Marseille, France and our CLIA lab, Virginia, United States.

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Testing Services

Increase throughput and expand your global footprint by outsourcing your assays (NGS, qPCR, ELISA, IHC etc.) to Veracyte. We operate CLIA labs in Marseille, France, and Richmond, Virginia, United States, which routinely run thousands of tests per year and have the ability to rapidly scale up.

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Contact our team to discuss your project

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