Human Hepatitis B Immunoglobulin Evaluation Service
Your Trusted Human Hepatitis B Immunoglobulin (HBIG) Evaluation Partner
CD BioGlyco has a reliable Biological Evaluation team to provide high-quality Pharmaceutical and Biological Analysis services. Our team also provides professional Pharmaceutical Analysis and Pharmaceutical Excipient Analysis services. HBIG is produced from healthy human plasma containing highly potent hepatitis B surface antibodies. It is purified by low-temperature ethanol protein isolation or other isolation methods and processed for virus removal and inactivation. Moreover, we provide high-level Human Rabies Immunoglobulin Evaluation, Human Tetanus Immunoglobulin Evaluation, Human Immunoglobulin Evaluation, and Anti-human T Lymphocyte Rabbit Immunoglobulin Evaluation services.
- Bulk analysis and final bulk analysis
- Protein content: CD BioGlyco provides accurate protein content determination service by bisulfite method. More than two peptide bonds contained in the protein form a purplish-red complex with Cu2+ in an alkaline solution, and its color shade is proportional to the concentration of protein within a certain range. The protein control solution is used as the standard curve, and the colorimetry is used to determine the content of protein in the test article.
- Purity: Based on professional operators, CD BioGlyco provides reliable cellulose acetate film electrophoresis and agarose gel electrophoresis analysis services.
- pH: CD BioGlyco provides a fast and accurate pH determination service.
- Residual ethanol content: Based on the fact that ethanol escapes by heating in saturated sodium carbonate solution and is absorbed by potassium dichromate-sulphuric acid solution to yellowish green to green color, we determine the ethanol residue in blood products by colorimetry.
- Pyrogen test: CD BioGlyco provides a complete pyrogen screening service including rabbit screening, feeding, injection to observation.
- Anti-HBs titer: CD BioGlyco uses enzyme-linked immunosorbent assay (ELISA) or radioimmunoassay (RIA) for anti-HBs titer testing.
- Sterility test: Under aseptic conditions, CD BioGlyco tests the inoculated media and controls.
- Final product-human HBIG analysis
CD BioGlyco provides the following professional final product analysis services:
- Visible particulates
- Molecular size distribution
- Abnormal toxicity test
- Double immunodiffusion assay
- Heat stability
- Purity
- Anti-HBs titer
- Immune electrophoresis
- pH
- Sugar content
- Sterility test
- Surface (color)
- Protein content
- Glycine content
- Pyrogen test
![Schematic diagram of human HBIG evaluation tools. (CD BioGlyco)](https://www.bioglyco.com/wp-content/themes/glycobio/img/4-14-2-6-human-hepatitis-b-immunoglobulin-evaluation-service-1.jpg)
Publication Data
Technology: ELISA, Deep sequencing
Journal: EBioMedicine
Published: 2015
IF: 11.205
Results: In this study, researchers constructed an HBIG booster vaccine model system and analyzed the immunoglobulin heavy chain library of circulating B cells by deep sequencing. It was found to be associated with an increase in the number of hepatitis B surface antigen (HBsAg)-specific plasma cells (PC) in the peripheral blood 7 days after vaccination. Kinetics of HBsAg-specific conforming memory cells in peripheral blood from at least day 14 to day 21 postvaccination. Moreover, researchers identified vaccine-specific cells by sorting and sequencing HBsAg+ (memory) and PC+ cells.
Fig.1 Kinetics of antigen-specific cluster. (Galson, et al., 2015)
Applications of Human HBIG Evaluation
- Human HBIG evaluation facilitates the development and evaluation of homologous human immunoglobulin.
- The combination of Human HBIG and hepatitis B vaccine assessment plays a key role in the prevention and blockade of hepatitis B.
- Comprehensive human HBIG evaluation lays a reliable foundation for the development and design of recombinant immunoglobulin.
Advantages of Us
- The reports we provide include raw mapping and professionally analyzed data reports. All data are delivered to the client's mailbox for the first time.
- Our researchers test the operating environment prior to sterility testing.
- For bulk, final bulk and -finished products, our specialized technical team offers different evaluation services.
CD BioGlyco provides professional pharmaceutical and biological analysis services that are beyond your expectations. We provide high-quality vaccine evaluation, immunoglobulin evaluation, protein derivative evaluation, and injection evaluation. Please do not hesitate to contact us for support.
Reference
- Galson, J.D.; et al. Analysis of B cell repertoire dynamics following hepatitis B vaccination in humans, and enrichment of vaccine-specific antibody sequences. EBioMedicine. 2015, 2(12): 2070-2079.
This service is for Research Use Only, not intended for any clinical use.