Do you have a prototype and would like to be able to manufacture it on a large scale, but you don’t have the means? Is the path to market too complex and threatening to stall your project? After more than 30 years developing, manufacturing and marketing rapid diagnostic tests, we put our experience as IVD manufacturers at your service.
OPERON has more than 30 years of experience developing, manufacturing and selling lateral flow tests (also known as rapid tests) in markets all over the world. Our production plant is highly automated and has specific state-of-the-art machinery, which allows us to cover not only our own manufacturing, but also that of potential customers who wish to manufacture their tests on a large scale.
We have experience in the veterinary, food and human diagnostic fields, and we work with all kind of samples (blood, serum, food, surface detection, saliva, bronchoalveolar lavage fluid, nasopharyngeal… etc), as well as with different technologies (gold nanoparticles, cellulose nanopearls, latex nanoparticles, fluorescence… etc).
In addition, OPERON has a demanding quality system, certified by ISO 13485. All our tests are CE marked, and we have experience registering lateral flow tests throught the FDA agency in the United States and the MHLW in Japan.
“Critical Diagnostics started working with OPERON nearly 10 years ago. They have been an outstanding manufacturing partner. They are very knowledgeable and efficient.”
“OPERON has been very supportive during our remote technology transfer process, and scale-up manufacturing to meet our commercial demands. We look forward to continuing our partnership as we develop additional point of care assays.”
“Working with OPERON has been one of our greatest partnerships. They are trustful, loyal, and transparent in their communication. Always willing to go the extra mile to support us and advise on what is best to ensure timely and the highest quality products are delivered to our customers.”
It depends very much on the market and the regulation that applies. Generally speaking, the whole process can take from 6 to 18 months, but it depends very much on each individual case.
It depends on the working hours invested in the project. Once this has been thoroughly analysed, an adjusted budget will be drawn up for the hours required to carry out the project.
If the sales expectation for your test is more than 100,000 units per year, it is recommended to automate the production of your test. However, setting up a production plant requires a large investment in material and human resources, which could cost around one million euros. This, in cases where there is no absolute certainty as to what the final market sales figure will be, can entail a significant risk. In order to minimize it, another option would be to subcontract this production to a solid company of the sector, with experience in the manufacture and handling of similar products. From OPERON, we have a long experience that will facilitate this process enormously.
It depends on the project. Each test is different both in size and in the materials it is made of. Some of them are sold in strip format, while most of them are sold in cassette format and with different cassette designs. In fact, several of these projects often require the tests to be compatible with the use of readers for the interpretation of results, which implies working with QR codes, reading cards or RFID tags.