Human Immunoglobulin Evaluation Service

Explore Unlimited Possibilities with Human Immunoglobulin Evaluation

Human immunoglobulin is made from healthy human plasma by cryo-ethanol protein isolation, followed by virus removal and inactivation. Pharmaceutical and Biological Analysis is an important part of biologics development and manufacturing. CD BioGlyco members have solid backgrounds in biomedicine, pharmacy, and other related disciplines, and provide the best Pharmaceutical Analysis, Biological Evaluation, or Pharmaceutical Excipient Analysis solutions according to our clients' needs.

Human immunoglobulin bulk and final bulk
- Content test: CD BioGlyco provides professional protein content analysis and residual ethanol content analysis. Based on the fact that proteins form a purplish-red complex with Cu²⁺ in alkaline solutions, we determine protein content in the blood products using the biuret method. Moreover, we determine the residual ethanol content in the blood products using ultraviolet-visible (UV-vis) spectrophotometry.
- Purity test: CD BioGlyco provides reliable purity analysis by cellulose acetate film electrophoresis and agarose gel electrophoresis.
- Pyrogen test: CD BioGlyco provides healthy and qualified rabbits for breeding, intravenous injection, and observation services. After injection, pay attention to the rabbit's weight, spirit, appetite, and abnormalities of excretion.
- Sterility test: CD BioGlyco cultures the samples in two separate media to promote the growth of residual anaerobes, aerobes, and fungi. We primarily use two methods of sterility testing for human immunoglobulin: membrane filtration and direct inoculation.
Human immunoglobulin final product
- Identification: We generally identify precipitation lines by observing them by immune electrophoresis or double immunodiffusion assay.
- Basic test: We offer some simple tests such as pH test, purity analysis, visible particle test, and heat stability test. Moreover, we provide high-quality sterility tests, abnormal toxicity tests, and pyrogen test services under the operation of professional staff.
- Content test: For the final product, we provide accurate protein content analysis, sugar content analysis, and glycine content analysis services. Our researchers provide the most appropriate content analysis services based on the molecular characteristics of the sample.
- Antibody titer: We offer specialized antibody analysis by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay, or specific agglutination.

Schematic diagram of human immunoglobulin assessment. (CD BioGlyco)

Publication Data

Technology: In vitro cleavage assay, Nano liquid chromatography-mass spectrometry (nLC-MS), Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE)

Journal: International Journal of Molecular Sciences

Published: 2019

IF: 5.6

Results: In this work, researchers developed cathepsins activity prediction models in silico and in vitro experiments. Combined in vitro proteomics and neural network modeling analyses revealed that cysteine histones S, L, and B were effective in degrading central nervous system proteins and immunoglobulin G (IgG) under specific conditions. The nLC-MS analysis data showed that IgG was completely degraded. Notably, cleavage within the variable region is important for the immunogenicity of the antibody.

Fig.1 Schematic diagram of detected peptides with predicted cleavage sites. Fig.1 Detected peptides overlap with predicted cleavage sites. (Høglund, et al., 2019)

Advantages of Us

Our staff provides content and purity determination relying on years of skilled operating experience and reliable analytical instrumentation.
Our biological analysis team has a comprehensive understanding of the client's needs, thorough communication, planning, and task segmentation. This helps in coming up with professional solutions to provide the best quality service to our clients.
Rely on our well-trained team and standardized service, we offer physicochemical assays and bioactivity assessment of human immunoglobulins.

Combining professional staff and advanced analytical systems, CD BioGlyco provides clients with satisfactory pharmaceutical and biological analysis solutions. We provide customized human immunoglobulin evaluation solutions according to the special needs of our clients. Please feel free to contact us.

Reference

Høglund, R.A.; et al. Human cysteine cathepsins degrade immunoglobulin G in vitro in a predictable manner. International Journal of Molecular Sciences. 2019, 20(19): 4843.

This service is for Research Use Only, not intended for any clinical use.