SIAT^® Immunogenicity Analysis of Vaccines

Immunogenicity is the ability of an antigen to cause the humoral or cell-mediated immune response in humans or other animals. The vaccine is a type of biological preparation that can produce active acquired immunity to a particular disease. A vaccine could be made of monoclonal antibodies (mAbs), proteins, peptides, PEGylated proteins, all of which are likely to be antigenic and greatly impacts the design of biomedical products. As a well-known expert in immunologic analysis, Creative Biolabs has abundant resources to develop advanced platforms to study the immunogenicity of clinical samples from vaccine studies. Particularly, we offer a wide range of techniques and validated methods for vaccine immunogenicity analysis in preclinical and clinical stages.

Overview

A key aspect of developing a new biologic, like a vaccine, is precisely assessing whether or not it is immunogenic or is able to cause an immune response. Immunogenicity is a property that can either be a desirable trait, for example in the generation of a robust protective immunity against certain pathogens, or an undesirable trait, for example when it relates to therapeutic candidates, where the immunity needs to be prevented.

The vaccine is typically associated with desirable immunogenicity, which is being at the center of vaccine efficacy. The injection of an antigen (from vaccines) can provoke an immune response directed the pathogen (e.g. virus, bacteria) aiming at protecting the organism. Vaccine immunogenicity and response are determined by factors and characteristics of both vaccine and host, including self-proteins, dose schedule, presence of adjuvants, route and site of administration, and vaccine handling.

SIAT® Immunogenicity Analysis Platforms at Creative Biolabs

Vaccine immunogenicity assays are required to measure immune responses and identify correlates of protection. The potential adverse response due to immunogenicity makes it a critical part of vaccine development and functional evaluation. At Creative Biolabs, our group has extensive experience in the development and validation of a series of analytical assays that are implemented in different stages of vaccine development. Remarkably, we have established the proprietary Sensitive Immunogenicity Assessment Technology® (SIAT®) system to study the immunogenicity for a variety of biological products or therapeutic treatments. Our quality efficacy and safety vaccine testing services including but not limited to:

• Enzyme-linked immunosorbent assay (ELISA)/Radioimmunoassay (RIA) - High sensitivity and specificity ELISA/RIA method can be used to test vaccine immunogenicity. Our ELISA is split into two types, solid-phase ELISA and solution ELISA, and RIA is classified into formats, antigen-binding assay (ABA) and two-site assay.
• Surface plasmon resonance (SPR) - It is an optical biosensing technology that has been used to detect protein interactions, by immobilizing the ligand on a thin metal film and measuring the shift in refractive index on the binding of analytes. The tool is applied in the vaccine area because of its real-time, label-free, and noninvasive nature.
• MSD-ECL assays - The test consists of mesoscale discovery (MSD) and electrochemiluminescence (ECL) technology.  This unique detection combines MSD platform with specialized tags which emit light by electrochemical stimulation. The intensity of light is captured by a charge-coupled device (CCD) camera and pixel intensity quantified. The system is the basis of achieving measurement of a log range of protein expression levels in different matrices.
• Lanthanide Fluorescence Immunoassay (LFI) - It makes use of a dissociation enhanced lanthanide fluorescence for the detection of anti-drug antibodies in samples. This technique is an upgrade version of traditional ELISA assays and doesn’t need an enzyme in operations.
• In vitro cell-based NAb-assay - This cell-based assay is designed to detect the existence of neutralizing antibodies (NAb). If the biological activity of a biotherapeutic product is limited to protein-protein binding or ligand-receptor binding, an MSD-Nab assay can be coupled to identify the presence of neutralizing antibodies.
• Reverse vaccinology (RV) - It is a multistep process that starts from the bioinformatic prediction of surface-expressed proteins, followed by their individual expression and evaluation of immunogenicity in a suitable vaccination model. The fulfillment of RV has driven the development of Bexsero, a vaccine composed of recombinant protein antigens and an outer membrane vesicle.
• In silico screening - T cell epitope content, one of the factors that contribute to the risk of immunogenicity, can now be analyzed by immunoinformatic algorithms. The clinical immunogenicity of a novel vaccine can be measured relatively accurately using in silico tools. We have integrated in silico immunogenicity into the pre-clinical process of vaccine discovery and development.

Advantages

• Advanced platforms for vaccine immunogenicity and efficacy studies
• Full range of laboratory services to support vaccine trials
• Project scope is fully defined and is reflected in our quotations
• Accurate assessment results with reproducible protocols

Vaccine development is a complex multistep process and the concept of immunogenicity of an antigen is frequently encountered under this context. To test the efficacy and safety of a vaccine, evaluating the immunogenicity of a vaccine is necessary. As a reliable supplier in clinical vaccine development, Creative Biolabs always devotes to immunogenicity analysis of immune-related diseases. As immunoassays are constantly evolving, we provide clients custom services the level most suited to the clinical phase of vaccine immunogenicity analysis. For more information, please directly contact us or discuss with our experts today.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.