Validation and international regulatory experience for a mycoplasma touchdown PCR assay

Author:

Asarnow David,Warford Ann,Fernandez Lewis,Hom Jonathan,Sandhu Gursaneep,Candichoy Zayda,Luna Geraldine,Goldman Mark,Rarich Randy

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference11 articles.

1. Molecular biology and pathogenicity of mycoplasma;Razin;Microbiol Mol Biol Rev,1998

2. Center for biologics evaluation and research. Points to consider in the characterization of cell lines used to produce biologicals;Food and Drug Administration (FDA),1993

3. Development of a PCR method for mycoplasma testing of Chinese hamster ovary cell cultures used in the manufacture of recombinant therapeutic proteins;Eldering;Biologicals,2004

4. Rapid and sensitive PCR method for identification of mycoplasma species in tissue culture;Wong-Lee,1993

5. Protocol 4. Elimination of contaminating DNA within PCR reagents;Meier,1996

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