The necessary MONOCLONAL ANTIBODIES (MAbs) or RECOMBINANT ANTIGENS (rAg) needed in the manufacture of our tests are produced in our facilities.
Nowadays we have 7 bioreactors which can produce up to several grams of MAbs. Therefore, we can offer to our customers a wide list of monoclonal antibodies and even the possibility to manufacture their own antibodies in big quantities.
Also a fermentor helps us to offer our Recombinant Proteins to our customers.
These tests are based on the capture with specific probes of nucleic acids of amplified fragments by the polymerase chain reaction.
This capture can be done with immobilised probes either on to a membrane (OpeGen line, based on the Southern reverse blot) or with probes bounded to coloured latex particles (OligoGen line, based on the oligo-immunocromatography).
FACILITIES One of the guidelines of good laboratory practices in Molecular Biology recommends the availability of independent rooms for reagent preparation, DNA extraction, PCR preparation, and amplification. The Molecular Biology area in Operon S.A. is divided into 5 independent laboratories, with controlled access, and a positive pressure and UV irradiation system, minimizing the risk of contamination with PCR amplicons and ensuring the quality of every manufactured product.
These tests are based on the immunological capture of colored microbeads during its passage along a membrane on which the monoclonal antibody has been immobilized.
Lateral flow are produced using latex particles which allow to distinguish different colours in the result and control lines (PINK/RED, BLUE, GREEN, PURPLE). This fact makes our tests very attractive for the end-user.
We have been producing some of these tests for more than twenty years
OPERON was established in 1973 as a private R&D laboratory in the field of Immunochemistry. In 1983, OPERON started its international sales operation, and nowadays we are exporting to more than 50 countries all over the world.
An extremely important part of the launching of new products are the phases of Research and Development. These steps define and support the company strategy, to enable our researches to get special and innovative products, most of the time, unique in the market.
All the immunological IVD products offered by OPERON have been developed and are produced at its own facilities. The products are sold in more than 50 countries around the world with its own brand name, an OEM basis or in bulk.
HUMAN AND PHYSICAL RESOURCES
OPERON employs more than 60 people, the most part of them in R&D. 4000 square meters (own) laboratories and manufacturing facilities located close to Zaragoza (Spain).
PRODUCT LINES, MARKETS AND TECHNOLOGIES
OPERON currently develops and manufactures several product lines:
Raw Materials: Monoclonal Antibodies and Recombinant Antigens. Nowadays we have 7 bioreactors which can produce up to several hundreds of grams of MAbs. Rapid Tests: Immunochromatographic assays based on coloured latex particles. Molecular Diagnostic kits (Opegen and OligoGen products): Tests based on the capture with specific probes of nucleic acids of amplified fragments by the polymerase chain reaction. Customized Services: Personalised design according to the needs of the customer, large scale production of tests designed by the client, manufacturing in OEM format, co-operation with others in the development and manufacture of immuno and molecular assays...
Our quality systems meet the most important standards, focusing our efforts to manufacture our products with the highest quality and safety.
Manufacturer Licence - Directive 98/79/EC UNE_EN.ISO 13485 ISO 9001 GMP USA: FDA Registered Contract Manufacturer JAPAN: Accreditation of Foreign Drug Manufacturer Health Animal Products Manufacturer
Operon is seeking for distributors world-wide. The company is also open to consider co-operations in different countries, which could imply development of new tests, technology transfer and/or joint ventures.