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Introduction to Workshop Dr. Rajesh K. Gupta

Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, & Other Biological Products. Introduction to Workshop Dr. Rajesh K. Gupta. Goals and Objectives.

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Introduction to Workshop Dr. Rajesh K. Gupta

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  1. Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, & Other Biological Products Introduction to Workshop Dr. Rajesh K. Gupta

  2. Goals and Objectives • To Provide a Forum on Recent Scientific & Technical Achievements in Rapid Methods for Detection of Mycoplasma Contamination • To Shorten time taken to test for Mycoplasma Contamination – Helps in Development and Manufacture of Vaccines & Other Biologicals • Expedite Manufacturing Process for Pandemic Influenza Vaccines & Other Biologicals

  3. Aims • Evaluate Current Developments in Rapid Methods for Detection of Mycoplasma Contamination • Identify Promising Method (s) for further Evaluation and Collaborative Study • Evaluate Collaborative Study Design • Identify Mycoplasma Species • Samples (Matrices) • Participants and Roles • Common Protocol

  4. Alternate Methods • Rapid • At Least Same Degree of Assurance as the Current Methods with regard to Absence of Mycoplasma Contamination (Sample Volume) • Viable Mycoplasma • Complexity in Performing Test • False Positives (Impact on Product Availability) • Real Positives by New Methods

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