Vaccines are one of the most important biological products. The development of vaccines mostly requires a protein purification process. The unpurified antigen stock solution contains a large amount of substances in the culture medium, and impurities such as host nucleic acid, protein, and lipid. These impurities are usually used as a heat source, causing adverse reactions in individuals who are vaccinated. In order to achieve high vaccine purity, the vaccine needs to be purified to meet the requirements for safety and effectiveness. Methods commonly used in vaccine purification include ultracentrifugation, ultrafiltration, chromatography, polyethylene glycol and ammonium sulfate precipitation, etc., to achieve sufficient purity and antigen concentration.
Vaccines are derived from living organisms and their components are complex. Therefore, a specific detection method must be established to ensure the quality of the vaccine and the uniformity of its batch-to-batch quality.
To ensure the quality, safety and effectiveness of vaccines, Creative Proteomics can provide you with vaccine homogeneity analysis services and promote the development of your project. We are committed to becoming the most trusted biopharmaceutical partner, providing customers with high-quality, professional analysis services. We have a wealth of experience and advanced technology platform to ensure that you get high-quality results analysis reports.
We Can Provide but Not Limited to:
- Vaccine Purity Analysis
- Vaccine Polymer Analysis
- Vaccine Fragment Analysis
- Vaccine Isoform Analysis
- Host Cell Proteins Analysis
- Host Cell Residual DNA analysis
Technology Platform of Vaccine Homogeneity Analysis Service:
Creative Proteomics can combine a variety of technical methods to provide you with accurate vaccine homogeneity analysis services.
1) Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)
Two-dimensional gel electrophoresis has high resolution and can reveal the isoelectric point (pI) and relative molecular mass (Mt) of the sample. However, in the presence of the product, the types of HCP that can be detected are very limited due to the quenching of the dye during labeling, the limited 2D electrophoretic load, and the high concentration product that neutralizes the detection signal.
2) High performance liquid chromatography (HPLC)
The HPLC method has a small injection volume, high resolution, and quantification. The sensitivity of the UV detector can reach 0.01 ng.
3) ELISA
ELISA detects total HCP components, with good repeatability and high sensitivity.
4) Chromatography technology
- Size exclusion chromatography (SEC)
- Reversed-phase (RP) chromatography
- Affinity Chromatography
Chromatographic separation technology has advantages in simplifying operations, improving efficiency, saving energy and reducing costs. We have a chromatography medium with multifunctional ligands and a fully automated high-efficiency chromatography system, and have established a standardized analysis system.
5) Capillary Isoelectric Focusing
Isoelectric point detection and charge heterogeneity analysis of vaccine protein.
Advantages of Vaccine Homogeneity Analysis Service:
➢ Short time-consuming: The service adopts standardized analysis methods and high-efficiency data analysis software. At the same time, it adopts a fast and convenient sample processing procedure, which can greatly reduce the analysis time for vaccine homogeneity.
➢ Professional platform: According to your purpose and budget, we suggest a suitable platform for you to conduct structural analysis.
➢ High sensitivity: low abundance HCPs can be detected. Unbiased detection of unknown HCPs.
➢ Rapid turnaround time: 5-7 days to provide complete analysis report.
➢ Customized service: We can provide you with tailor-made services according to your needs, and you can choose the analysis plan you need.
Creative Proteomics' researchers can provide you with detailed experimental analysis programs, complete and comprehensive vaccine homogeneity analysis reports and other bioinformatics analysis reports. We insist on focusing on customer needs and assist biopharmaceutical companies to better complete research projects in terms of technology and analytical solutions to accelerate the marketization of their products.
