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High Quality – ISO13485

ISO Certified since 2008

If you are on this page it means quality is important to you. This makes two of us. At Biocult we believe that creating something great is easy but to reproduce and trust your product for the next decades is the next level.

Biocult is part of Hycult biotechnology B.V. and is EN ISO 13485:2016 certified since 2008.

Please find our certificate below and for all other quality questions please contact us.

The value of high quality

Consistent results due to high quality products: at Biocult we understand the value of good production. How do we make sure that we can maintain high quality:

we are proud to be EN ISO13485:2016 certified. With this certificate you have the guarantee that we have our processes validated, robust and consistent.

We work according to Good Manufacturing Practises (GMP). Our technicians are all trained to work according to GMP and Good Laboratory Practices (GLP). Every process related to the products is documented in procedures: even the cleaning of the production of the production line is documented. Not only GMP or GLP is important, also the documentation is key. Therefore, we make sure everything is documented and that we work according to Good Documentation Practices (GDP). Is there a change in our process? Specific change control procedures are in place to make sure that all changes are not only documented, but also have no influence on (the quality of) the products.

Our labs are located in our head quarter in Uden, The Netherlands. The labs are new and renovated and we work with high quality equipment. All our equipment is tested and needs to be approved for IQ, OQ and PQ before we start working with it.

Last, but not least, we have over 25 years of experience in antibody production and ELISA development. With our dedicated team we have everything in house to make sure we can offer you the best products.

Looking to outsource your production or development, but not the facilities, personnel or techniques to test your antibody production? Get in contact with Biocult and share your wishes with us.

Make your work easier

At Biocult we believe that the best results are obtained if we think along with your needs.

We strive to do this in a smart and practical way, by always searching for the best custom solutions to get the results or products you are looking for. With our 25 years of experience and knowledge we can translate your thoughts to products, we can assist you with your (antibody) production or upscaling or we can translate your antibodies to an assay.

  • We think along on a smart and practical way, always searching custom solutions and looking for the best results
  • We work in a personal way with knowledge of production and the process
  • We act together and are committed and sincere from start to finish
  • We believe in dedicated contacts and short and transparent communication

Do not hesitate to get in contact and share your thoughts with us about your needs or wishes. You can contact us via e-mail or give us a call to discuss al options.

Let's make something great together