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Rapid Microbiological Methods and Mycoplasma Testing

7 November 2017

Objectives

This conference will review the current knowledge about developments in modern microbiological methods and mycoplasma detection strategies for quality control in biopharmaceutical manufacturing.

This one-day meeting provides the opportunity to discuss the recent advances in the area of the newest technological developments as well as practical aspects and concerns of meeting the regulatory requirements. State-of-the-art presentations from authority speakers, as well as industrial and academic experts in the field of microbiological detection and identification and mycoplasmology with particular focus on the current methodologies their implementation and validation will provide an in-depth overview.

Background

The scientific progress in the field of cellular and molecular biotechnology led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs). Against this background, the safety of such new technologies, products and applications becomes more importance. One important topic in the focus of risk assessment and safety is the contamination with microorganisms and mycoplasmas and their detection, prevention and control.

Target Audience

This conference is of interest to professionals from

  • Biotechnological & Biopharmaceutical Companies
  • Contract Service Laboratories
  • Academic Research Institutions and Organizations
  • Government Agencies
  • Cell Culture Collections
  • Supplier Detection Systems

with responsibilities in

  • Manufacturing
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Research & Development
  • Process Development
  • Validation

Programme

Validation of a Rapid Hybrid Mycoplasma Method
Susan Brand-Hoefs, MSD, The Netherlands

  • Background on Mycoplasma and the need for a rapid test in the biotech industry
  • The rapid Mycoplasma project within MSD
  • Challenges during method development
  • Method validation data

Validation of Mycoplasma Testing based on PCR in cellular products
Dr. Klára Sochorová, Sotioa.s., Czech Rpublic

  • Validation done by the supplier of the kit
  • In-house validation - Preanalytical requirements
  • In-house validation - Positive control selection
  • In-house validation - Limits
  • In-house validation - Troubleshooting

Successful implementation of a RMM for mycoplasma testing as release test on a commercialized product in Europe
Marine Marius, Sanofi Pasteur, France

  • Presentation of the RMM selected for mycoplasma testing
  • Presentation of the validation strategy on a commercialized product
  • Preparation and submission of an analytical variation to replace compendial methods as release test

Implementation of the MycoTOOL Mycoplasma Real-Time PCR Assay as Early Warning System and for Lot-Release Testing
Dr. Carl-Ulrich Zimmerman, Mycoplasma Biosafety Services GmbH, Austria

  • Main considerations for product-specific validation approaches based on the intended assay application:
    • Feasibility, prevalidation, validation and comparability studies
  • The choice of experimental design:
    • Mycoplasma reference standards panel, spiking procedure and spike level verification, sample preparation and DNA extraction
    • Examples of suitable MycoTOOL Real-Time PCR test layouts: Test sample replicates and controls

MODA EM Solution and its integration with the Growth Direct system for EM testing
Robert Lutskus, Lonza, USA
Kham Nguyen, Rapid Micro Biosystems, USA

  • Real life examples of what triggers a concern to an auditor
  • Needed Training and Instructions
  • Work and data flow
  • Optimize efficiency and minimize sampling
  • Reducing data errors

Current Regulatory Expectations for the Microbiological Safety of ATMPs - A Roadmap to Approval
Jan-Oliver Karo, Paul-Ehrlich-Institut – German Federal Institute for Vaccines and Biomedicines

  • Characteristics, Challenges and Regulatory Basis
  • Microbiological Safety of ATMPs
  • From Current Status to Paradigm Change
  • Rapid Microbiological Methods - A Question of Sterility?
  • Regulatory Requirements for Mycoplasma Control
  • Case Studies from Microbiological Assessment

Validation of a qPCR-based test for Gram positive and Gram negative bacteria
Dr. rer. nat. Alexandra Müller-Scholz, Sartorius-Stedim-Biotech, Germany

  • Area of application of a PCR-based presence/absence test for bacteria
  • Validation of a qPCR-based method for the detection of bacteria
  • Comparability study of a qPCR-based test and growth-based detection (Ph. Eur. 2.6.1)
  • Ring trail study with a qPCR-based test for bacteria

Phylogenetic analysis based on 16S rRNA gene sequence for bacterial identification in the biopharmaceutical industry – Where we are now?
Dr. Sunhee Hong, Charles River Microbial Solutions, United States

  • The importance of accurate identification
  • 16S rRNA gene sequencing for bacterial identification
  • Challenges for using genotypic identification methods in today’s world
  • Do we need to analyze the full length 16S rRNA gene for bacterial identification?
  • Utilizing Alternative Phylogenetic Markers for Closely Related Organisms

Moderators

Dr. Sven Deutschmann
Roche Diagnostics, Penzberg, Germany
Chairman ECA Rapid Microbiological Methods Working Group

Prof. Renate Rosengarten
University of Veterinary Meedicine Vienna & Mycoplasma Biosafety Services, Vienna, Austria

Speakers

Dr. Susan Brand-Hoefs, MSD, The Netherlands
Microbiologist

Kham Nguyen, Rapid Micro Biosystems, USA
Director of Sales.

Jan-Oliver Karo, Paul-Ehrlich-Institut – German Federal Institute for Vaccines and Biomedicines
Quality assessor and an expert advisor for the microbial safety of advanced therapy medicinal products (ATMPs) on national and international level.

Marine Marius, Sanofi Pasteur, France
Leads RMM implementation in ARD Eu for mycoplasma and endotoxin testing

Dr. rer. nat. Alexandra Müller-Scholz, Sartorius-Stedim-Biotech, Germany
Scientist R&D Microbiology department

Dr. Sunhee Hong, Charles River Microbial Solutions, USA
Senior Staff Scientist. Responsible for curating the bacterial and protein coding gene sequence libraries for the Accugenix ID services.

Dr. Klára Sochorová, Sotioa.s., Czech Rpublic
Working in cell therapy area. Particpates in the development from the scientific concept to the medicinal product used in phase III study.

Dr. Carl-Ulrich Zimmerman, Mycoplasma Biosafety Services, Vienna, Austria
Head of Research and Development

Robert Lutzku, Lonza, USA
Global Product Delivery Manager for MODA™ EM.

News

Please also read the article "Choosing and validation modern microbiological methods" issued in the March issue of Cleanroom Technology.