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

Publication Data

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.