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 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

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

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