Good Laboratory Practice (GLP) is the global gold standard for conducting non-clinical health research. For pre-clinical safety studies, GLP compliance is required for the development of drugs (small molecules) and biological agents (monoclonal antibodies, therapeutic proteins, vaccines, and gene therapy agents).
Creative Biolabs adheres to the Good Laboratory Practice (GLP) research requirements for the safety and efficacy of drug candidates. Our GLP quality control system is widely used in non-clinical research to ensure consistency, reliability, repeatability, quality, and integrity of recombinant proteins, therapeutic antibodies, cancer vaccine safety, and efficacy testing.
Creative Biolabs’ biologics process development team can develop the entire process or optimize individual steps in the previous process to ensure that the test studies meet GLP requirements. Upstream, the process development team can screen a variety of production strains to select cell lines that best express the drug. We can optimize processes such as high cell density fermentation to increase product yield and produce the highest quality products in the most efficient and cost-effective manner. For early process development, our biologics team works in tandem with the protein analysis team to ensure product integrity during the early development process.
According to document ICH Q5D ‘Quality of Biological Products: Derivatives and Characterization of Cellular Substrates for the Production of Biotechnology/Biological Products’, Creative Biolabs performs cell bank characterization on the following cell lines:
For more details, please feel free to contact us for project quotations and more detailed information
We offer a variety of analytical techniques for stability testing:
Combining our cell banking, antibody & protein, and vaccine engineering services, we provide GLP/cGMP-compliant cell bank to ensure our customers have access to inexhaustible phenotypically consistent cells.
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