Vaccine Analytical Development & Qualification
Creative Biolabs offers Vaccine Analytical testing programs for live attenuated vaccine, inactivated vaccine, subunit vaccine, vector vaccine, conjugate vaccine, DNA and RNA vaccine. The analytical testing of vaccines provide evidence that the vaccine and its intermediates meet the specifications defined within the BLA. With more than ten years industry experience, our scientists guarantee to help your product reach development milestones faster and effectively.
Identity, purity, impurity, potency and quantity should be demonstrated by analytical testing and control of the manufacturing process. Creative Biolabs offers the following vaccine analytical support services:
Identity Tests
Creative Biolabs offers a wide range of tests designed specifically based on unique characteristics of the molecular structure and other properties. Current analytical and process technologies are provided for better specificity, including physicochemical, biological and immunological assays, to ensure that all components are adequately distinguished.
Current methods are as followed:
Chromatographic
- Chromatography
- Gas chromatography
- High-performance liquid
Electrophoresis
- Polyacrylamide gel
- Electrophoresis
- Immunoelectrophoretic
- Capillary electrophoresis
Immunological
- Immunodiffusion
- Immunoelectrophoretic
- Dot-blot
- Western blot
- Enzyme-linked
- Immunosorbent assay
- Radioimmunoassay
Purity Tests
Creative Biolabs offers purity tests to identify potential process or product-related impurities that derived from equipment, the process, or inherent product impurities.
Process-related impurity testing
- Chromatography
- Electrophoresis
- Mass spectrometry
- Nuclear magnetic resonance
- Loss on drying
- Water determination
Product-related impurity testing
- Chromatography
- Electrophoresis
- Mass spectrometry
- Nuclear magnetic resonance
Microbial Tests
Creative Biolabs provides bioburden, sterility, endotoxin and adventitious viral and mycoplasma agent testing services for our clients. We also involve PCR to detect the presence of contaminating adventitious agents in the process and in final formulation.
Potency Tests of Vaccine
Potency tests are available to assure that the vaccine produces the desired immunologic effect per specification. Biological-based manufacturing methods are filled with variable and potency testing is a tool to guarantee consistency of commercial vaccines.
Includes:
- Traditional animal-based assays
- Cell culture-based assays
- Biological activity or response induced by immunologic interactions
- Ligand or receptor binding assays
Stability Tests
We have a variety of analytical techniques for use of stability testing. Unlike chemical drugs, bio-products like vaccines are unstable during storage. The high sensibility of Proteins and other macromolecules to environmental change, such as light, heat or radiation, may lead to the unsafety and inefficacy of the biological medicinal product.
For any kind of vaccines or any production process, Creative Biolabs can provide a variety of analytical techniques to help your products meets the GMP requirements.
All of our products can only be used for research purposes. These vaccine ingredients CANNOT be used directly on humans or animals.
