Identity testing of cell substrates is required under the general regulations for biological products (21 CFR 610.18) and the European Pharmacopoeia.
The European Pharmacopoeia version 2009 will set the use of nucleic acid fingerprinting methods as mandatory to test cell lines for the production of vaccines for human use, in term of identity and purity.
Already, DNAVision routinely provides services to authenticate cell lines using a nucleic acid based approach:
The DNA fingerprinting analysis discriminates cell lines on the basis of species-specific DNA sequences. The method developed by DNAVision uses a PCR amplification followed by digestion with restriction enzymes to obtain a cell line specific pattern analyzed by capillary electrophoresis. This method allows unequivocal discrimination of common mammalian cell lines to establish the identity of the cells but also detection of contamination to demonstrate freedom from contaminating cells.
Fig: Example of genetic analyzer restriction patterns used to authenticate cell lines
The benefits of working with DNAVision SA for your DNA Fingerprinting testing include:
The client provides:
The Final Report includes a description of the overall project design, presentations of raw data and calculation data when needed. .
For regulated projects: all working steps in the process flow are documented and filed. Raw data is archived for five years. Documentation and certificates are produced by the quality assurance department.