10-Species Cell Line Authentification Kit

Overview - SHENTEK^® 10-Species Cell Line Authentification Kit

Cell identification testing is a mandatory requirement set by the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the European Pharmacopoeia, and the Chinese Pharmacopoeia. It is essential for confirming the origin of production cells and ruling out cross-contamination with other cell types.

The 10-species Cell Line Authentication Kit provides a rapid, user-friendly and highly effective solution for species verification and contamination detection. This kit utilizes mitochondrial genes-specifically Cytochrome Oxidase I (CO I), Cytochrome B (Cyt B), or Cytochrome Oxidase II (CO II) as molecular targets for the identification of 10 commonly used cell lines in biologics manufacturing (refer to Table 1). It employs a multiplex PCR assay with species-specific primers that produce distinct amplicon sizes for each cell line. The results are then analyzed through horizontal DNA electrophoresis, allowing for species identification and potential cross-contamination detection based on the number and size of the amplified bands.

The detection limit for species identification and cross-contamination detection has been validated no more than 1%. The kit enables detect simultaneous detection of 10 species listed in the Table 1 in a single reaction.

                             Table 1. List of 10 cell species detectable by this kit

Introduction - SHENTEK^® 10-Species Cell Line Authentification Kit

Specification -SHENTEK^®10-Species Cell Line Authentification Kit

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