Human Hepatitis B Immunoglobulin Evaluation Service

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)

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 Statistical analysis of antigen-specific clusters.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

  1. 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.

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About Us

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.

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