7th International Mycoplasma qPCR Testing User Day

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 (nucleicacid 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 track is aimed at people working in the following areas:

• Representatives of the regulatory and authorisation authorities
• Specialists in laboratories for Endotoxin and Pyrogen Testing
• QA/QC personnel in the biopharmaceutical environment

Highlights

• EP 2.6.7: User Challenges, Troubleshooting, and Best Practices
• Ensuring Robust qPCR-Based Mycoplasma Detection
• From Plates and Curves to Partitions: Mycoplasma Testing Goes Digital
• Validation Experiences and Case Studies
• Regulatory Developments and Regulators Experiences and Expectations

Moderators

Julian Mochayedi & Alexander Bartes, Roche

Congress Registration

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