6th International Mycoplasma qPCR Testing User Day

Background & Objectives

The contamination of biopharmaceutical products, i.e. classic biologics, but also modern cell and gene therapy products with mycoplasmas, e.g. due to contamination of cell cultures during the manufacturing process, poses a potential health risk to patients. Mycoplasma can influence virtually every parameter of cell culture, often with only minor visible effects, leading to uncontrollable conditions that are undesirable in the pharmaceutical industry. Regulatory authorities therefore require manufacturers to test their biopharmaceutical products and ensure that the released products are free of mycoplasma. Most regulatory authorities have issued guidelines that include protocols for mycoplasma testing, and some provide recommendations for the validation of rapid NAT (nucleic acid amplification techniques) testing methods. This provides you with a scientifically sound introduction to the field of rapid mycoplasma testing with a special focus on NAT and, in particular, qPCR methods. It includes lectures, case studies and interactive roundtable discussions by users for users.

Target Audience

The Pre-Conference Workshop is directed to responsible personnel involved in Quality Control testing of biopharmaceuticals and biologics, e.g.:

• QC Director, Manager, Scientists, Microbiologists, and Process Microbiologists
• Analytical Experts
• Biosafety and Pathogen Safety departments
• Bioassay Developers
• Regulatory departments

It is also useful for service providers, such as contract research organisations and contract manufacturers.

Register now