5th International Mycoplasma qPCR Testing User Day

PharmaLab Pre-Conference Event on 25 November 2024

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 Developers
  • Responsible Authority Employers

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

Moderation

Haidy Wafy, Roche

Download the complete programme as PDF

Click on the image to download the complete conference programme as PDF.

Programme

Conference Registration

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Programme

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

Mycoplasma NAT Techno Roadmap and Experiences from Sanofi Vaccine
Thierry Bonnevay, Sanofi Pasteur

  • Mycoplasma
  • Techno roadmap
  • Regulation
  • Validation NAT and comparability with compendial assay
  • Challenges from health authorities (mainly CBER)

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

  • Matrix suitability testing – Protocol optimization to handle high cell backgrounds
  • Validation data from User

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

  • Opportunities and challenges of the updated revision of EP and USP from a developer´s perspective
  • What needs to be considered with the new RT-PCR system with regard to additional RNA detection
  • Comparison of the new RT-qPCR system with existing one
  • CFU vs. GC Standards
  • Exemplary validation data

Lessons Learned during Implementation and Validation of a modern Mycoplasma Detection
Orm Nieuwenhuizen, Johnson & Johnson

  • Updates and new Insights gained the last year with an Automated Mycoplasma PCR:
    • Summarized Validation Results of the Automated Mycoplasma PCR System
    • Prevention of Cross Contamination with the Automated Mycoplasma PCR
    • Preliminary Study Results with Heat Inactivated Mycoplasma

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

  • Fast and easy mycoplasma detection workflow using dPCR
  • Significantly enhanced sensitivity using RT-dPCR compared with dPCR mycoplasma testing
  • The QIAcuity Mycoplasma Quant Kit workflow is validated to meet pharmacopeia requirements and is compatible with a variety of sample matrices
  • Validation of dPCR-based mycoplasma testing using mycoplasma standards

Replacement of a DNA Extraction System in a Validated Rapid Mycoplasma Method
Susan Hoefs, MSD

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

  • pplication of an ultra-rapid NAT-based Method for Mycoplasma Testing: BIOFIRE® FILMARRAY® System
  • Application of the method in compliance with regulatory chapters (e.g. Ph. Eur. 2.6.7 + Draft)
  • Process steps for implementation, validation and transfer ➔ also as a 3-party-process
  • Case-Study: verification at Labor LS, matrix suitability tests

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

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