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Frequently Asked Questions: Residual DNA Testing


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Frequently Asked Questions: Residual DNA Testing

1. Why is residual DNA testing important?
2. What test can your residual DNA Testing services use?
3. What do the species of DNA detected include?
4. What about regulatory compliance?
5. What are the methods to detect and quantify of residual host cell DNA?


1. Why is residual DNA testing important?

Manufacturers of vaccines and other biological products must ensure that final products which are derived from continuous mammalian cell lines contain low levels of residual host cell DNA (HCD). The presence of HCD in the final product is of significant concern because of:

1) Potential transfer of activated cellular and viral oncogenes, particularly if the cell substrate is tumorigenic;
2) Production of infectious viruses from viral DNA;
3) Aberrant gene expression by the insertion of sequences into sensitive control regions of genes.

2. What test can your residual DNA Testing services use?

Our residual DNA Testing services can be used for raw material testing, final product release, lot release testing, and cleaning validation.

3. What do the species of DNA detected include?

Creative Biogene's technology is able to detect residual DNA from a variety of species, including human (several cell lines), mouse, monkey, pig, hamster, chicken, mollusk, insect, yeast and E. coli (plasmid and chromosomal).

4. What about regulatory compliance?

All testing can be performed from research level to testing regulated according to Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP) for Finished Pharmaceuticals. Raw materials are obtained from approved vendors whose products meet required specifications. Certificates of Analysis are maintained for specific a lot of reagents used in testing.

5. What are the methods to detect and quantify of residual host cell DNA?

Creative Biogene uses highly sensitive methods to detect and quantify trace amounts of residual host cell DNA. From the nonspecific detection of total DNA to the detection of species-specific target sequences, the methods include:

1) Threshold Assay- uses DNA binding proteins with high affinity for single-stranded DNA for nonspecific quantification of total DNA
2) Hybridization Assay - a hybridization-based approach to detect specific DNA of defined origin
3) qPCR Assay - a quantitative PCR-based approach to detect specific DNA of defined origin; targets a specific gene sequence for amplification

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