For over 10 years, Agro-Bio has been offering customized protocols to develop the anti-idiotypic antibodies: the development of multi-species polyclonal antibodies and monoclonal antibodies.
To support the requirements of authorities (antibody generation, characterization and management of critical reagents), we provide the development of customized protocols, basing on the antibody format and its different application scenarios (immunogenicity test, pharmacokinetic (PK) analysis, neutralizing antibodies (NAb), etc.).
• Time-tested and application-based customized protocols
• Supporting the implementation of the regulatory agency guidances recommendations
• Critical reagent life cycle management : from initial reagent generation, the characterization and the re-test over time.
• The developed antibodies right are based on our customers requirement, royalty-free services
An idiotype is a set of idiotopes of the variable region of an immunoglobulin. The anti-idiotypic antibodies (anti-IDs) bind to the idiotope of the variable region of an another antibody.
These anti-idiotypic antibodies are mainly used for pharmacokinetic (PK) analysis, to investigate the fate of the drug in the body, or as a positive control in immunogenicity and NAbs (neutralization study) tests. There are two types of anti-idiotypic antibodies: neutralizing and non-neutralizing. The neutralizing anti-idiotypic antibody is specific to the paratope of the therapeutic antibody i.e. it blocks the interaction between the therapeutic antibody and its target.
The development of an anti-idiotypic antibody could be performed through a monoclonal protocol (hybridoma technology) or a polyclonal immunization program.
Recommended method by regulatory agencies for ADA test: The guidelines for bioanalysis methods recommend the use of critical reagents leading to an immune response as close as possible to the patient’s immune response. The nature of the polyclonal immune response in animal reference models such as rabbits or goats is similar to human immune response. If the immune response is not observed in the reference animals, the immunization of other species could be performed (chicken, guniea pig,...).
Robust and fast method: For over 20 years, Agro-Bio has been developing ADA and anti-idiotypic protocols for pharmaceutical applications by offering time-tested immunization and purification protocols.
Unique know-how in subtractive purification techniques: The anti-idiotypic antibody is obtained by subtractive purification methods using an immobilized "irrelevant" antibody. This method eliminates antibodies produced against the constant regions to collect the antibodies specific for the variable regions of the therapeutic antibody.
Acknowledge know-how to select the anti-idiotypic of interest: To obtain this monoclonal antibody, our scientific team will define a customized protocol: definition of the antigen for the immunization program and the control antigens, choice of the immunization protocol (number of mice, injections, bleeds…), evaluation of the immune response, screening criteria evaluation of screening programs, selection of the clones of interest and in vitro production.
Rapid screening by BIACORE® platform (SPR technology): The clones are screening against the whole antibody for a positive selection (the clones secreting the anti-idiotypic antibodies of interest) at the earliest stages of hybridomas cellular growth. The positive cloned could be further characterized by BIACORE to determine the affinity constant of the antibodies.
Secure storage of the critical reagent: The obtained clones will be stored in liquid nitrogen for long term security. The reproducibility will be controlled/characterized over time according to the initially defined parameters (database).
Rabbit polyclonal antibody
Mouse monoclonal antibody
+++ (~ 3 months)
+ (~ 5 à 6 months)