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Cell Line Characterization Service


Creative Biogene offers a vast range of cell line characterization services in manufacture process of pharmaceuticals

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Cell Line Characterization Service

Creative Biogene offers a vast range of cell line characterization services in manufacture process of pharmaceuticals, biopharmaceuticals and pre-clinic/clinic products. With outstanding experts and excellent platforms, we will provide reliable and satisfying cell line characterization services at a short turn-around time. Moreover, our experienced scientists will assist you in determining when and how to test in concordance to the governing guideline. We will work close with you.

Cell systems are used as tools and models for basic research and industrial applications over the last few decades. These cell systems rely on the use of cell lines. Therefore, it is necessary to do cell line characterization and authentication before cells are used for research or manufacture. The way to evaluate cell line characterization depends on the species of the cell line (e.g., human, chicken, hamster) and its intended use (e.g., gene therapy, vaccine production). The routine test recommendation includes history and general characteristics of cell line, the cell bank system and quality control testing. In some cases, there is need for validation studies of virus removal and inactivation in the manufacturing process. In addition, stricter standard testing is conducted when the cell lines are used to produce antibody, recombinant DNA technology products and gene therapy.

Cell Line Characterization Service

Creative Biogene provides a comprehensive cell line characterization service with high-quality results. We offer cell line characterization service for:

  1. Cell lines;
  2. Master cell banks (MCB) and Work cell banks (WCB);
  3. End-of-production cells and post production cell banks;
  4. Raw materials and final products;
  5. Virus seed stock.

For more information, please contact us at or 1-631-626-9181.

References:

  1. FDA: Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, 1993.
  2. FDA: Guidance for Industry, Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, 2010.
  3. Reid, Y. A. (2011) Characterization and Authentication of Cancer Cell Lines: An Overview. in Cancer Cell Culture: Methods and Protocols (Cree, I. A. ed.), Humana Press, Totowa, NJ. pp 35-43.

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