Immunoassay Production Service

We are a trusted provider of high-quality immunoassay kits for a variety of applications. With 30 years of experience, we have the expertise and capability to develop and manufacture custom immunoassays which meet your specific needs. Whether you need an Enzyme-Linked Immunosorbent Assay (ELISA), Chemiluminescent Immunoassay (CLIA) or Fluorescent Immunoassay (FIA), we can help.

Contract Manufacturing at BioGenes


Phase 1 - Enquiry & project planning

  • Thorough discussion of your project details, requirements, and available materials
  • Our team will review your request and provides a quote

Phase 2 - Development, testing & trial production

  • Incoming goods testing of raw materials and reagents will be conducted
  • A feasibility study to ensure the suitability of the materials is performed
  • A test production establishes the parameters for the final product
  • A null lot is delivered for your approval, thus ensuring that it meets your specifications

Phase 3 - Manufacturing & quality control

  • The details of your project are received and the requirements are confirmed 
  • Following the working instructions (SOPs), we manufacture your custom product according to ISO 9001:2015 standards
  • All your reagents are kept in cold storage, thus ensuring the longevity of the product throughout its life cycle
  • Thorough quality control tests are conducted throughout the production process, ensuring consistency and accuracy
  • The manufacturing and release of products is documented, including internal batch record documents
  • We provide a certificate of analysis (CoA) for every manufactured batch, according to the product specifications established
  • The product is assembled as a ready-to-use kit including an instruction leaflet

Phase 4 - Logistics

  • From our facility in Berlin, we use specialized companies in temperature-controlled shipping services worldwide
  • With our wealth of experience in long-distance international shipping, we are well-equipped to handle all aspects of the logistics process, including navigating customs and tariffs
  • We strongly recommend that our customers utilize a courier service and obtain insurance for their shipments


  • Cost Savings: Outsourcing can be a cost-efficient option, particularly for smaller companies, which are unable to produce assays in-house. A minimum of 50 kits is required per order.
  • Time Savings: BioGenes has the required expertise, equipment and resources to perform the process efficiently, allowing you to focus on other aspects of your business, such as research and development.
  • Scalability: Contract immunoassay production is flexible, allowing for rapid scale production that meets project requirements. After our recent expansion, we are able to manufacture up to 3,000 assay plates per week, ensuring the timely delivery of high-quality products.
  • Confidentiality: BioGenes understands the importance of keeping your customer data and processes confidential. 


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