5th International Mycoplasma qPCR Testing User Day

Background & Objectives

Mycoplasma contamination of biopharmaceutical products (also known as biologics or large molecules) resulting from cell culture contamination
in the manufacturing process poses a potential health risk to patients. Mycoplasmas can affect virtually every cell culture
parameter with often only minor visible effects, creating an uncontrollable environment that is undesirable in the biopharmaceutical industry.
Therefore, regulatory agencies require manufacturers to test their biopharmaceutical products and to ensure the absence of mycoplasmas
in released products. Most regulatory agencies have issued guidelines that provide protocols for mycoplasma testing, and
some give recommendations for the validation of rapid NAT (nucleic acid amplification techniques) testing methods. This satellite symposium
will give you a scientifically sound introduction into the field of Rapid Mycoplasma testing with a specific focus on NAT and more
specifically on qPCR methods. It includes talks, case studies as well as interactive round table discussions from users to users.

Target Audience

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

• QC Managers
• Microbiologists, and Process Microbiologists
• Analytical Experts
• Biosafety and Pathogen Safety SME’s
• Bioassay Developer
• Responsible Authority Employers

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

Registration

Programme

Update on the Revision of Ph. Eur. Texts related to the Mycoplasma Project
Dr Thuy Bourgeois, EDQM Strasbourg, France

Rapid Mycoplasma Testing – Methodology, Pitfalls and Experiences
Dr Rudolf Zirwes, independent

Real-Time PCR-based Mycoplasma Testing – Verification for the Intended Use: Data from a User
Dr Robert Hertel, Sartorius

RT-qPCR based Mycoplasma Detection from a Developer’s Perspective
Caroline Paeschke, Minerva Biolabs

Mycoplasma Testing of ATMPs: Current Regulations, Challenges and Trends
Rashid Idd Kihwelo, Shelys Pharmaceuticals

Sensitive and Rapid Testing for Mycoplasma Contamination using Digital PCR
Dr Francesca Di Pasquale, Qiagen

Mycoplasma Testing - Experiences in Practice
Speaker MSD

Ultra-Rapid NAT-based Method for Mycoplasma Testing – Implementation, Validation and Transfer Strategy
Yasmin Heynen, Labor LS

Mycoplasma Testing – Authorities Experiences and New Developments
Jan-Oliver Karo, Paul-Ehrlich Institut, German Federal Institute for Vaccines and Biomedicines