Immunogenicity of Biologics

The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins…composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.” Biologics are derived from living sources, whether human, animal or other microorganism and are used to treat specific medical conditions where no other treatment options are available.

Immunogenicity refers to a person’s immune response to a biologic, in turn making the biologic lose its effectiveness over time. This immune response is commonly seen in patients taking biologics to treat rheumatoid arthritis. This presents a challenge for scientists and researchers to develop biologics that don’t spark an immune response so more patients can have success and find relief with these kinds of treatments.

Immunogenicity Test Request Received by Contract Laboratory

• Bioanalytical COntract Research Organization CRO needed for T cell-based cellular immunogenicity assay development and Testing of Antibody-based immunogenicity assay. cellular assay to identify CD4+ and CD8+ t cell responses. Assay ideally would include 3-5 different donors for any given HLA type. Targeted HLA-specific donors will be identified by in silico assessment, approximately 6-12 different HLA types per assay. Assay set-up will be developed in-house and transferred to CRO. Service will be needed as an on-going project-based work flow.
• Pharmaceutical Preclinical laboratory needed for Large Molecule Bioanalysis Studies ( PK and Immunogenicity)
• EMAI FDA GLP Contract Research Organization CRO needed for FDA GLP preclinical toxicology and Immunogenicity studies with primates where our products can be evaluated by IV route, administrated daily during 12 weeks and 4 weeks of recovery period. We want evaluated comparatively two products with two level doses and a control group. The number of animals per group would be 3 animals/sex/group. It would be evaluated Hematology/Biochemistry parameters. Also, we want do toxicokinetics, immunogenicity and local tolerance evaluations.
• Preclinical Laboratory, Contract Research Oranization CRO needed for Influenza vaccine proof-of-concept studies. Peptide immunizations in HLA-transgenic mice followed by inoculation with WSN virus (BSL-2). Monitoring of clinical signs, morbidity, and mortality, and in vitro immunogenicity studies (FACS for antigen-specific T cells). Client will cover transgenic mice costs (from Taconic) and peptides (commercial synthetic)
• University needs California FDA GMP Preclinical Laboratory needed for FDA immunogenicity studies
• Canada FDA GMP Preclinical Toxicology Laboratory needed for study with recombinant Sendai virus based vectored vaccine. Sendai virus is a mouse pathogen although the strain we are using is attenuated it still causes bronchial pneumonia in rodents. No effect in rabbits and hopefully none in higher order mammals such as NHP or humans. We need a GLP tox lab that is prepared to conduct studies in mice, rabbits and NHPs. The studies would involve assessing the virulence (pathogenicity), virus growth kinetics and immunogenicity in the target species. Capability to take bronchial and nasal lavage samples form NHPs would be required as well as the ability to conduct virus assays and PCR assays or arrange for them to be done. Some immunogenicity assays (ELISA) would be required to assess the immune responses tot eh virus and HIV antigens.
• Bioanalytical Laboratory needed for immunogenicity analysis, neutrelizing antibodies, anti drug antibodies
• or see more test requests!

For more information on how to respond to these test requests, or to submit your own immunogenicity of biologics test request, call us toll free at 1-855-377-6821 or submit a request on our website!

Originally posted 2017-06-15 13:29:24.