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.
With over 30 years of industry experience, we possess the necessary expertise and capability to develop and manufacture custom immunoassays which are tailored to meet your specific needs.
Quality Assurance & Control
Our facility is ISO 9001:2015 certified and we use only the highest quality reagents and materials to ensure consistent performance, batch after batch.
Outsourcing the manufacture of immunoassays through contract manufacturing 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.
As a professional contract manufacturer, BioGenes has the necessary expertise, equipment and resources to perform the process efficiently, allowing you to focus on other aspects of your business, such as research and development.
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.
BioGenes understands the importance of keeping your customer data and processes confidential. We will work with you to establish clear guidelines for handling sensitive information, and ensure that only authorized personnel have access to it.
How to Proceed
1. Enquiry & Project Planning
- Send a draft of your project details to us
- Our team will review your request and get back to you with a quote as soon as possible
2. Developing, Testing & Trial Production
- Send the raw materials and reagent to us
- We then conduct an incoming goods testing and feasibility study to ensure the suitability of the materials
- A test production (trail production) establishes the parameters for the final product
- A null-lot is delivered for your approval, thus ensuring that it meets your specifications
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 for every manufactured batch, according to the product specifications established
- The finished product is delivered to you, ready for use
- From our facility in Berlin, we specialize 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
- In order to ensure complete peace of mind, we strongly recommend that our customers utilize a courier service and obtain insurance for their shipments