SIVILAB®
IMMUNOGENICITY STUDIES
Immunogenicity - is the ability of a biotechnological drug to induce an
undesirable immune response in the
organism
The number of drugs with recombinant proteins or peptides as active components is constantly increasing. The use of such drugs may be accompanied by the development of serious side effects due to the manifestation of undesirable immunogenicity. According to the recommendations on conducting trials of biological medicinal products (Decision of the EEC Council No. 89 dated November 3, 2016, Chapter 25), clinical studies should include the evaluation of immunogenicity of therapeutic proteins, which is carried out by detecting and characterizing the anti-drug antibodies (ADA).
Assessment of antibody
ㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤneutralizing capacity
ㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤㅤNeutralizing antibodies (NAb)SCIENCE INTELLIGENCE
VERIFICATION INDEPENDENCE
The development of a method to assess ADA neutralizing capacity requires a deep understanding of the protein drug mechanism of action, taking into account the functional characteristics of all its domains. The applied analytical method should allow a reliable assessment of the level of antibody neutralizing capacity and their clinical significance.
Assessment of antibody neutralizing capacity Neutralizing antibodies (NAb)
SCIENCE INTELLIGENCE
VERIFICATION INDEPENDENCE
The development of a method to assess ADA neutralizing capacity requires a deep understanding of the protein drug mechanism of action, taking into account the functional characteristics of all its domains. The applied analytical method should allow a reliable assessment of the level of antibody neutralizing capacity and their clinical significance.
Cell-based methods have a number of undeniable advantages because they allow the simultaneous testing of multiple functional domains of a protein on natural functional targets.
ADA from the analyzed sample and the drug are added to a cell culture containing a pre-engineered functional domain (receptor) involved in the interaction with the tested drug. If a decrease in drug activity is observed upon addition of ADA, this indicates the neutralizing capacity of the antibody and vice versa.
ADA from the analyzed sample and the drug are added to a cell culture containing a pre-engineered functional domain (receptor) involved in the interaction with the tested drug. If a decrease in drug activity is observed upon addition of ADA, this indicates the neutralizing capacity of the antibody and vice versa.
This type of assay is designed to determine ADA neutralizing properties by examining the effect of antibodies on the binding of the drug of interest (e.g., a monoclonal antibody) to its target. A decrease in the efficiency of drug-target binding in the presence of ADA indicates the neutralizing properties of these antibodies.
The laboratory repository of SIVILAB® Scientific Research Center, where biosamples are stored, is equipped according to the GLP standard.
- Storage at a low t° (-20°C, -60°C and -80°C).
- Continuous monitoring of the temperature parameters with an independent warning system.
- Emergency standby power supply.
- Video surveillance.
During the planning and execution of the studies, as well as during the further preparation of the reports, our specialists follow a number of domestic and foreign guidelines:
- Decision of the EEC Council No. 89 dated November 3, 2016 “On Approval of the Rules for Conducting Studies of Biological Medicinal Products of the Eurasian Economic Union”
- EMA and FDA Good Laboratory Practice (GLP) guidelines
- FDA Guidance Document - Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection -2019
- EMA Guideline on Immunogenicity assessment of therapeutic proteins -2017
The laboratory repository of SIVILAB® Scientific Research Center, where biosamples are stored, is equipped according to the GLP standard.
- Storage at a low t° (-20°C, -60°C and -80°C).
- Continuous monitoring of the temperature parameters with an independent warning system.
- Emergency standby power supply.
- Video surveillance.
During the planning and execution of the studies, as well as during the further preparation of the reports, our specialists follow a number of domestic and foreign guidelines:
- Decision of the EEC Council No. 89 dated November 3, 2016 “On Approval of the Rules for Conducting Studies of Biological Medicinal Products of the Eurasian Economic Union”
- EMA and FDA Good Laboratory Practice (GLP) guidelines
- FDA Guidance Document - Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection -2019
- EMA Guideline on Immunogenicity assessment of therapeutic proteins -2017
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121205, Moscow, Skolkovo Technopark, Bolshoy Boulevard,
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
info@sivilab.ru
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
- +7 3952 550-330
info@sivilab.ru
© 2024 SIVIlab
Services
Contact Us
121205, Moscow, Skolkovo Technopark, Bolshoy Boulevard,
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
info@sivilab.ru
42, building 1
664048, Irkutsk, Rosa Luxemburg St., 184/1
- +7 3952 550-330
info@sivilab.ru
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