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2nd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Event

11 November 2019

Early Bird Rebate for congress delegates: Book until 31 August 2019 and get an early bird rebate on the congress ticket.

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 satellite symposium 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 Developer
  • Regulatory departments

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

Programme

Pitfalls and Issues on Mycoplasma Testing according to Pharmacopoeial Requirements -
A Regulator´s View on ATMPs

Jan-Oliver Karo, Paul-Ehrlich Institut (PEI)

MycoTOOL – Method Development and Generic Validation Strategy
Christiana Schnitzler, Boehringer Ingelheim

Automatization of Mycoplasma detection using a new fast and easy to use molecular method
Dr Félix A. Montero Julian, bioMerieux

Comparability Study of a Real-time PCR-based Mycoplasma detection kit with the culture method according to EP 2.6.7
Diana Patzelt, Sartorius Stedim Biotech

Mycoplasma detection system and its verification
Andrej Steyer, University of Ljubljana

Summary
Dr Peter Steinhardt, Roche

Moderation

Dr Peter Steinhardt, Roche Diagnostics

Speakers

Jan-Oliver Karo, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines
Division Microbial Safety. Quality assessor and national expert advisor for the microbial safety of ATMPs.
Member of the “Cell Therapy Products” Working Party of the German Pharmacopoeia Commission.

Dr Félix A. Montero Julian, bioMerieux, France
Scientific Director.

Diana Patzelt, Sartorius Stedim Biotech, Germany
Scientist - Applications for Molecular Biology.

Christiana Schnitzler, Boehringer Ingelheim, Germany
Head Mycoplasma Laboratory.

Dr Peter Steinhardt, Roche Diagnostics, Germany
International Alliance Manager, Business Development Pharma & Biotech, EMEA LATAM.

Andrej Steyer, University of Ljubljana, Slovenia
Institute of Microbiology and Immunology Faculty of Medicine.