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1st International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Event

19 November 2018

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

Rapid Mycoplasma Testing - A revolution for Quality Control?
Prof. Renate Rosengarten, University of Veterinary Medicine Vienna

qPCR Mycoplasma Testing at Roche Pharma - method development, validation, and global roll out
Dr Alexander Bartes, Roche Diagnostics

External quality assessment of Mycoplasma NATs: regulatory implications
Dr Micha Nübling, Paul Ehrlich Institut

Case Study - Implementation of MycoTOOL as a Release Test
Damian Derincovsky, Novartis

Case Study - Approval of MycoTool Roche qPCR assay by FDA, FAMHP and MHRA, accelerating QC release of an autologous cell therapeutic product
Aurore de Lavareille, Celyad

Parallel Round Table Discussions in parallel

Table 1
MycoTOOL Q&A Session and experience exchange with the developer of the method (Roche Pharma)

Dr Sven Deutschmann and Dr Alexander Bartes, Roche Diagnostics

Table 2
Rapid Mycoplasma Testing as an early warning/in-process control

Speaker t.b.a.

Table 3
Rapid Mycoplasma Testing for ATMPs

Jessica Wynendale and Kim Baert, Anacura
Aurore de Lavareille, Celyad

Table 4
Implement MycoTOOL on non-validated instrumentation (e.g. other PCR cycler)

Dr Manuela Natoli, Cancer Research UK
Dr Giusy Canino, Roche Diagnostics

Moderation

Dr Peter Steinhardt, Roche Diagnostics

Speakers

Dr Alexander Bartes, Roche Diagnostics
Senior QC Manager.

Damian Derincovsky, Novartis
QMS&T Facilitator BioProduction Operations Huningue, France.

Dr Sven M. Deutschmann, Roche
Head of ASAT Adventitious Agents Testing & Alternative Microbiological Methods, Global Analytical Science & Technology (gASAT), Global QC.

Aurore de Lavareille, Celyad, Belgium
QC Lab Supervisor.

Dr Micha Nübling, Paul-Ehrlich-Institut, Germany
Section Head Molecular Virology.

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

Prof. Dr Renate Rosengarten, University of Veterinary Medicine Vienna
Professor and Chair of Bacterioloy and Hygiene