4th 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 pharmaceutical 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
• Responsible Authority Employers

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

Programme

Current Revision of Ph. Eur. chapter 2.6.7 Mycoplasmas and its Impact on other Ph. Eur. Texts
Dr Thuy Bourgeois, EDQM Strasbourg, France

NAT-based Methods for Mycoplasma Testing – Validation Strategy in the View of the Revision of the European Pharmacopoeia Chapter 2.6.7
Yasmin Heynen, Labor LS

Next Generation PCR Closed System Allowing for 1-Hour Mycoplasma Release Test of CGT Products
Dr Caroline Kassim, bioMérieux

Development of a Digital PCR-based Mycoplasma Detection Kit
Dr Nicole Paland, Minerva

Comparison of two Mycoplasma Methods in QC laboratory (Training, Sample Flow and Analysis Time)
Dr Aline Le Tiec, Novartis

Change of Mycoplasma NAT-based Method: Management of a Kit Discontinuation
Marine Marius, Sanofi

Mycoplasma Testing & Evaluation for ATMPs – lessons learned!
Dr Olga Müller, Tetec

Mycoplasma Real-Time PCR: Generic Method Validation of T-cell Culture
Alexander Bartes, Roche