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Scientific Posters:
Validation and Integration of an Automated Nucleic Acid Extraction System for Mycoplasma Testing
This poster provides a strategy for the of the validation of the AutoMate ExpressTM Nucleic Acid Extraction System, with emphasis on demonstrating comparability between manual and automated real-time PCR workflows.
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Isolation of Mycoplasma Arginini from Commercial Bovine Sera and Its Implication in Contaminated Cell Cultures
Barile, M. F., and J. Kern. (1971). “Isolation of Mycoplasma Arginini from Commercial Bovine Sera and Its Implication in Contaminated Cell Cultures.” Experimental Biology and Medicine, vol. 138, no. 2, pp. 432–437.
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Mycoplasma Contamination – The Invisible Threat?
Breth, B. (2009). Mycoplasma Contamination – The Invisible Threat? European Biopharmaceutical Review. 70-74.
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Historical Overview of Mycoplasma Testing for Production of Biologics. American Pharmaceutical Review
Chandler, D.K.F., D.V. Volokhov, and V.E. Chizhikov. (2011). Historical Overview of Mycoplasma Testing for Production of Biologics. American Pharmaceutical Review, 14(4).
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Preparation of Reference Stocks Suitable for Evaluation of Alternative NAT-Based Mycoplasma Detection Methods
Dabrazhynetskaya, A., Furtak, V., Volokhov, D. V., Beck, B. R., & Vladimir Chizhikov. (2014). Preparation of reference stocks suitable for evaluation of alternative NAT-based mycoplasma detection methods. Journal of Applied Microbiology, 116(1), 100–108.
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Mycoplasma Infection of Cell Culture
Levine, E. M., Stevenson, R. E., Patterson, M. K., Del Giudice, R. A., & Gardella, R. S. (1984). Mycoplasma Infection of Cell Culture: Effects, Incidence, and Detection. In Uses and standardization of Vertebrate Cell Cultures: State of the art review conference: Proceedings of a symposium conducted by the Tissue Culture Association Committee on Standardization in collaboration with Corning Medical at Crowne Plaza Hotel, Rockville, Maryland on October 3-5, 1983 (pp. 104–115). Tissue Culture Association.
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Mycoplasma Contamination of Cell Cultures
Drexler HG, Uphoff CC. (2002) Mycoplasma contamination of cell cultures: Incidence, sources, effects, detection, elimination, prevention. Cytotechnology, 39(2):75-90. DOI: 10.1023
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Optimal Culture Conditions for Detection and Isolation of Mycoplasma Contaminants from Cell Cultures
In Stanek, G., Gabridge, M. G., Lundin, D. J., Stanek, G., Cassell, H., Tully, J. G., & Whitcomb, R. F. (1990). Optimal Culture Conditions for Detection and Isolation of Mycoplasma Contaminants from Cell Cultures. In Recent Advances In Mycoplasmology: Proceedings Of The 7th Congress Of The International Organization For Mycoplasmology, Baden Near Vienna, 1988 (pp. 943–944). Gustav Fischer.
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Mycoplasma Detection and Control
Lincoln, C. K., & Lundin, D. J. (1990). Mycoplasma Detection and Control. United States Federation for Culture Collection Newsletter. 20 (4):1-3.
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Cell Culture Contamination: Sources, Consequences, Prevention and Elimination
Mather, J. P., Barnes, D., Lincoln, K. L., & Gabridge, M. G. (1998). Cell Culture Contamination: Sources, Consequences, Prevention and Elimination. Methods in Cell Biology (Vol. 57, pp. 49–65) Academic Press.
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Mycoplasmal Contamination of Cell Cultures within the Clinical Diagnostic Laboratory
Lundin, D.J. & Lincoln, C.K. (1994). Mycoplasmal Contamination of Cell Cultures within the Clinical Diagnostic Laboratory. American Clinical Laboratories.
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Prevention and Detection of Mycoplasma Contamination in Cell Culture
Nikfarjam, L., & Farzaneh, P. (2011). Prevention and Detection of Mycoplasma Contamination in Cell Culture. Cell Journal, 13(4), 203–212.
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Alternative Methods for Mycoplasma Testing
Parenteral Drug Association. (2010). Alternative Methods for Mycoplasma Testing (PDA Technical Report No. 50).
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PDA Workshop on Mycoplasma Contamination
Potts, B. J. (Ed.). (2007). PDA Workshop on Mycoplasma Contamination by Plant Peptones. Parenteral Drug Association.
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Understanding and Managing Cell Culture Contamination
Ryan, J. A. (1994). Understanding and Managing Cell Culture Contamination (Vol. CLS-AN-020). Corning Incorporated Life Sciences Technical Bulletin.
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The Growth and Long Term Survival of Acholeplasma Laidlawii in Media Products
Windsor HM, Windsor GD, Noordergraaf JH. The growth and long term survival of Acholeplasma laidlawii in media products used in biopharmaceutical manufacturing. Biologicals. 2010;38(2):204–210.
Regulatory References
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Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
CBER, FDA. (1993). Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, Attachment #2 – Recommended Procedures for Detection of Mycoplasma Contamination in Biological Products in Cell Substrates.
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Characterization and Qualification of Cell Substrates and Other Biological Materials
FDA. (2010), Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications
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Elimination of 21 CFR 610.30 Test for Mycoplasma
FDA. (2020). Elimination of 21 CFR 610.30 Test for Mycoplasma.
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Content and Review of Chemistry, Manufacturing, and Control for Human Somatic Cell Therapy
FDA. (2008). Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs).
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Chemistry, Manufacturing and Control for Human Gene Therapy
FDA. (2020). Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).
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Cell Substrates for the Production of Vaccines for Human Use
European Directorate for the Quality of Medicines. (2020) Cell Substrates for the Production of Vaccines for Human Use. European Pharmacopeia. (5.2.3).
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European Directorate for the Quality of Medicines
European Directorate for the Quality of Medicines. (2020). Mycoplasmas. European Pharmacopeia. (2.6.7)
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Quality of Biotechnical Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
European Medicines Agency. (1997). Quality of Biotechnical Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.
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Mycoplasma Testing for Cell Substrates
The Japanese Ministry of Health, Labor, and Welfare. (2016). Mycoplasma Testing for Cell Substrates used for the Production of Biotechnological/Biological Products. In Japanese Pharmacopoeia (17th ed., pp. 2460–2464).
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Mycoplasma Tests
The United States Pharmacopeial Convention. (2018). General Chapter <63> Mycoplasma Tests. In The United States Pharmacopeia: The National Formulary
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Validation of Alternative Microbiological Methods
The United States Pharmacopeial Convention. (2018). General Information Chapter <1223> Validation of Alternative Microbiological Methods. In The United States Pharmacopeia: The National Formulary.
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Validation of Compendial Procedures
The United States Pharmacopeial Convention. (2018). General Information Chapter <1225> Validation of Compendial Procedures. In The United States Pharmacopeia: The National Formulary.
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