Coris  >  CDMO

Our Contract and Development Manufacturing Organization offering

What we do

At Coris BioConcept, we offer a full-service CDMO platform tailored to in-vitro diagnostics: from development through pilot production to commercial launch. Leveraging over two decades of expertise in rapid tests (immunochromatography, electrochemistry, LAMP (isothermal amplification), ELISA) and our newly strengthened molecular portfolio, we partner with innovators worldwide to bring their assay ideas to life. Sample types may be blood, plasma/serum, urine, respiratory samples, stool, saliva, crust/pustule, bacterial cultures (colonies or liquid), blood culture,...

What we offer

Coris BioConcept offers a broad range of services from concept feasibility to manufacturing, including prototype development, industrialization and regulatory support.

  • In-depth expertise: our team masters all phases of diagnostic assay development, leveraging a full range of skills to meet your objectives.
  • Flexibility: we start from your objectives and build around them, ensuring every solution fits your project perfectly.
  • Cost-effectiveness: being a SME helps us to significantly reduce development time and cost.
  • Reliability: we have been selling our own tests since last century across the world, guided by a strict quality management system (ISO 13485-2016), and with a focus on robustness and reproducibility. Our commitment and the quality of the service provided has led us to become a long-term service provider to several companies (up to 8 projects for a unique company).
  • Intellectual Property: protecting both of our proprietary data is our top priority. We operate under strict confidentiality protocols, and by keeping all developments in-house at our Belgian facility with a dedicated team, we ensure your IP remains fully safeguarded.

Case studies

Case Study 1 - From ELISA to rapid tests for internal QC

Challenge:

A company had developed an in-house ELISA assay to monitor protein production as part of its quality control procedures. However, the process was time-consuming, resourceintensive, and the assay's limited shelf life increased production and QC costs.

Solution:

Coris BioConcept successfully adapted the ELISA into a lateral-flow format, achieving superior performance and a significantly extended shelf life (up to 48 months). Beyond technical transfer, Coris also supported the client in regulatory matters and now manufactures the rapid test routinely under a long-term partnership.

Case Study 2 - Expanding portfolio with a new technology

Challenge:

A diagnostic company producing a broad range of antigen and antibody ELISAs wanted to enter new markets by converting selected assays into dipstick or cassette (lateral-flow) formats. The project required rapid turnaround and scalability.

Solution:

Coris BioConcept mobilized a cross-functional R&D team, completing multiple assay conversions within a few weeks. The resulting ICT assays met all performance expectations and are now manufactured unlabelled by Coris, allowing the customer to handle final branding and packaging independently.

Case Study 3 - Scaling up a startup's innovation

Challenge:

A young innovative company (YIC) developed a promising lateral-flow prototype using benchtop equipment but lacked industrial manufacturing capabilities.

Solution:

Coris BioConcept reviewed and optimized all production protocols to ensure robust, reproducible large-scale manufacturing. Pilot lots were successfully produced and final packaging completed at Coris' facility. Coris' Quality and Regulatory teams also supported the client through the registration process, ensuring compliance and readiness for market launch.

FAQs

What types of assay technologies do you have experience with?

  • We have developed assays for Coris and for partners on several technologies, including Immunochromatography (Dipsticks or Lateral Flow ImmunoAssays (LFIA)), Loop-Mediated Isothermal Amplification (LAMP), enzyme-linked immunosorbent assay (ELISA), Reversetranscriptase Polymerase Chain reaction (RT-PCR), Rapid ElectroChemical Detection (RED).

How long do you need for a project?

  • Depending on the size and the starting point of the project, it can last from a couple of weeks to several months, or even years if we include the whole registration process.

Can you help us if we already have a validated prototype?

  • Yes, we can step in at whatever stage of the test development, from early stages to production.

What kind of samples you need for the tests you develop?

  • We can detect your target where it site: blood, plasma, serum, stool, urine, saliva, skin, etc.