CD BioGlyco mainly measures three states of HRIG including bulk, final bulk, and final product.
Basic analysis
pH test
Surface test
Heat stability test
Purity test
Visible particulate test
Abnormal toxicity test
Pyrogen test
Sterility test
Content analysis
CD BioGlyco provides accurate protein, residual ethanol, sugar, and glycine content determination services.
Our researchers determine the protein content of the final bulk and final product by biuret and Kjeldahl method respectively.
The residual ethanol content is calculated by measuring the absorbance using the dish diffusion method.
For sugar and glycine content, we use high-performance liquid chromatography (HPLC) to provide accurate quantification. Notably, glycine reacts with an excess of 6-aminoquinolinyl-N-hydroxysuccinimidylcarbamate (AQC) for pre-column derivatization.
Molecular size distribution
We use size exclusion chromatography (SEC) to determine the IgG monomer and dimer content of HRIG and the separation between the monomer peak and the cleavage peak.
Final product identification
Double immunodiffusion assay: We add HRIG and anti-human, anti-horse, anti-bovine, anti-pig, and anti-sheep serum or plasma to two adjacent wells of an agarose gel plate. After a while, a distinct precipitation line forms only with the anti-human serum or plasma.
Immune electrophoresis: We separate HRIG by electrophoresis and observe the position and shape of its precipitation arc.
Rabies antibody potency
For antibody potency, we mainly provide two analysis services including a mouse neutralization test (MNT) and a rapid fluorescent focus inhibition test (RFFIT).
For anti-HBs, we provide professional radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA) services.
Results: In this study, researchers assessed human and equine RIG responses to commercial vaccine-induced rabies-neutralizing antibodies with the aid of hamster models. The decrease in FAVN was confirmed by ELISA-assayed titer flanks. In addition, IgG was detected by an anti-hamster total IgG (H+L) coupling and significantly cross-reacted with IgM antibodies. Overall, the combined human and equine RIGs transiently interfered with rabies-neutralizing antibody responses and this interference was similar to that of the purified Vero cell rabies vaccine candidate (PVRV-NG) vaccine candidate.
Fig.1 Immunogenicity of PVRV-NG and standard-of-care vaccines in the presence of HRIG. (Bernard, et al., 2022)
Applications of Human Rabies Immunoglobulin Evaluation
HRIG evaluation raises awareness of the disease and develops the next generation of vaccines to effectively prevent infection.
HRIG evaluation helps to further elucidate the extent and nature of RIG interference with new vaccine candidates.
HRIG evaluation plays a key role in the development of similar types of immunoglobulin products.
Advantages of Us
Based on the pharmaceutical and biological analysis needs of our clients, our professional staff plans the analysis and evaluation program.
Our SEC analysis is also suitable for the analysis of IgG monomer and dimer content in human immunoglobulin analogs.
The RFFIT we provide is very reproducible and requires less sample volume.
CD BioGlyco provides systematic pharmaceutical and biological analysis services to our clients in the research business and industry worldwide. Our efficient biological evaluation team makes every effort to fulfill our client's every need. Contact us at your convenience for assistance.
Reference
Bernard, M.C.; et al. Inhibitory effect of concomitantly administered rabies immunoglobulins on the immunogenicity of commercial and candidate human rabies vaccines in hamsters. Scientific Reports. 2022, 12(1): 6570.
This service is for Research Use Only, not intended for any clinical use.
CD BioGlyco is a world-class biotechnology company with offices in many countries. Our products and services provide a viable option to what is otherwise available.