Vaccine Analytical Development & Qualification

Vaccine Analytical Development and 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
Vaccine Analytical Development and Qualification

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
Vaccine Analytical Development and Qualification

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

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

Vaccine Analytical Development and Qualification

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.


Our services are for research use only. We do not provide services directly to individuals.

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CONTACT US

USA
45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
Fax: 1-631-207-8356
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