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Quick Guide to Use of Custom HuCAL Recombinant Antibodies
The following information describes how you can use custom antibodies generated from the HuCAL® recombinant monoclonal antibody generation service. This information is intended as an informal guide.
Bio-Rad Terms and Conditions (T&C) are available on request and define the use of custom HuCAL antibodies in detail. The T&C are included in a formal quotation for a custom project.
The antibody, any part of it or any recombinant molecule derived from it, may be used for your internal in vitro research purposes without any further license from Bio-Rad AbD Serotec GmbH. HuCAL antibodies are not intended for use in humans, and may not be used for therapeutic, prophylactic or palliative purposes.
Before sharing the antibody with a collaborator or other third party outside your organization, and/or allowing a collaborator or third party to order the custom antibody from Bio-Rad for their internal in vitro research use, contact us to agree this in writing. The use of the antibody by the collaborator or third party remains subject to the T&C.
If the antibody is to be used in a clinical setting for the purpose of patient screening or monitoring of a therapeutic product or drug, a Clinical Monitoring License is required. The license must be in place when the first clinical trial begins.
If the antibody is used as a component in an in vitro diagnostic (IVD) assay and the IVD assay becomes FDA approved, CE marked or other equivalent diagnostic approval, an In Vitro Diagnostic License is required. The license is due on FDA approval, or other equivalent.
If the antibody is to be commercialized, i.e. made available for customers to buy, a Commercialization License is required before the product is launched. The antibody must be sold for in vitro research purposes only.
Further details about the licenses and their terms are available on request.
The custom HuCAL technology generates recombinant Fab antibodies and fully human immunoglobulins in vitro, without the immunization of animals. With traditional custom monoclonal antibody generation in animals, the product received is typically a hybridoma cell line. In the case of the custom HuCAL service, the main product received is purified recombinant antibody.
The unique Fab antibody DNA sequence and amino acid sequence are also available to you on request (light chain, Fd chain and tags).
Using the sequence information you may produce the antibody at your facility for your internal use. The use of the antibody, any part of the original antibody or any other recombinant molecule derived from it, remains subject to the T&C and licenses. You are responsible for obtaining any additional intellectual property rights that may be required for production and use of your antibody.
'Comment' article in Nature in February 2015 highlighting the advantages of antibody sequence knowledge and recombinant antibody production
Standardize antibodies used in research
All intellectual property (IP) rights arising from the permitted uses of the antibody are owned by you. IP may be generated on the use of the antibody in your application. IP cannot be claimed on the antibody sequence itself because you are not the inventor of the antibody sequence. All uses of the antibody remain subject to the T&C.
Bio-Rad has the right to generate antibodies against any target for itself or for a third party, provided that these antibodies are made independently, without the use of any antigen materials supplied to us by a customer or made by us for any customer’s custom project.