European Microbiology Conference 2021

European Microbiology Conference

on 5 - 6 May 2021

Highlights

  • Pharmacopoeial Developments and GMP  Expectations
  • Burkolderia cepacia Complex – Regulatory Requirements and Methodology
  • Monitoring and New Methods – from Comparison up to Validation
  • Water Activity – USP and Laboratory Experiences
  • Endotoxin- and Pyrogen Testing
  • ECA - OOS/OOL Guide: New Chapter for Sterility Test Failures

Objectives

This event offers you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control.

Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to ask questions in several Q & A Sessions throughout the conference.

Background

The role of pharmaceutical microbiology is getting more and more important. The microbial control concept also increasingly in the focus of regulators during product submission and inspections. Current challenges are Endotoxin-masking effects (“Low Endotoxin Recovery”,, implementation of alternative microbiological methods, control of cell based products and the ongoing issues with contamination control – there were an increasing number of findings in the authority reports.

The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Audience

This conference is of interest to professionals in microbiology from:

  • Pharmaceutical and biopharmaceutical companies
  • Academic Research Institutions
  • Government agencies
  • Contract service laboratories

who are involved in

  • Contamination control
  • Monitoring
  • Product Testing
  • Validation
  • Quality affairs
  • Regulatory affairs
  • Research and development

Moderators

Dr Sven M. Deutschmann,
Roche, Chairman ECA Pharmaceutical Microbiology Working Group

Axel H. Schroeder,
Administration Manager, Pharmaceutical Microbiology Working Group

Programme

 Emmanuelle Charton

Implementation of European Pharmacopoeia methods: conventional methods versus alternative methods

Emmanuelle Charton, EDQM

  • Conventional methods, “suitable” methods, “example” methods, “substitute” methods, “alternative” methods: how to find your own method of choice and how to implement it.
  • How much flexibility is provided by Ph. Eur.?

 

 Christian LombLaurent LeblancTony Cundell

Experiences with Burkolderia cepacia Complex

  • Part 1 Laboratory Experience with existing Methods, Christian Lomb, Labor LS
  • Part 2 Specific Growth Media, Laurent Leblanc, bioMérieux
  • Part 3 PCR, Tony Cundell, USP

 

 Peter Huonker

Case Study - Comparison of Monitoring Systems

Peter Huonker, Früh Packaging Technology

  • Application area and function
  • Comparison of two monitoring systems - Valimon from ValiSys and Labwatch Monitoring from GE (Amphenol)
  • Pros/Cons

 

 Dr Kai Nesemann

Continuous microbial air monitoring for aseptic filling lines

Dr Kai Nesemann, Sartorius

  • Continuous air sampling for 8 hours non-stop using the Gelatine-Membrane-Filtration according to Annex 1
  • Presentation of a case study comparing the traditional impaction method with the filtration method with regard to microbial recovery

 

Martin Coffey

Water Activity Part 1 – USP <992>

Martin Coffey, USP Expert Volunteer

 

 Christine Weiß

Water Activity Part 2  - An important factor forrisk assessment

Christine Weß,  Labor LS

  • Practical Experiences
  • Application in the context of risk assessment

 

 Jesper Hjorth

Experiences and Data from OWBA – Online Water Bioburden Analyser

Jesper Hjorth, Novo Nordisk

  • Experience with different OWBA’s on PW and WFI
  • Comparison of online data from different water types
  • Status on OWBA implementation in Novo Nordisk

 

 Dr Ulrich ZuberMichaela Ann Kinney

VBmicro: a suitable lab device for bioburden determination of water and buffers in less than 1 hour

Dr Ulrich Zuber & Michaela Ann Kinney, Roche

  • Feasibility studies
  • Steps to implementation

 

 Dr Rainer Gallitzendörfer

Inspection of Micro Labs /Expectations of an Inspector on microbiological QC

Dr Rainer Gallitzendörfer, Local Government of Upper Bavaria

 

 Barbara Gerten

Performance Testing of Membrane Filters

Barbara Gerten, Merck

  • The revised ISO 7704 – background and changes
  • Batch testing by demonstrating the suitability in the whole system in combination with the specific culture medium
  • Additional testing for new types of membrane filters or in case of problems

 

 Dr Jan Feuser

Microbial control in Downstream of biopharmaceutical manufacturing

Dr Jan Feuser, Boehringer Ingelheim

  • General aspects of microbial control strategy
  • Microbial weak spots in Downstream manufacturing
  • Approaching a bioburden investigation
  • Attributes of microbial assessments

 

 Ioana Venet

Endotoxins versus pyrogen testing: how the European Pharmacopoeia texts can help

Ioana Venet, EDQM

  • An overview of the sources of information on these aspects in the Ph. Eur. 
  • A presentation of the current requirements in the Ph. Eur. texts
  • An update on the Ph. Eur. methods that can be used for the testing of pyrogens and/or endotoxins

 

 Wolfgang RudyLarissa Nkenmei-Pietsch

Determination of Pyrogens: optimization of the MAT for Medical Device testing

Wolfgang Rudy & Larissa Nkenmei-Pietsch, TentaMedix GmbH

  • Endotoxin vs. Non Endotoxin Pyrogen detection in vitro
  • Monocyte Activation Test as in vitro replacement of the Rabbit Pyrogen Test
  • Pyrogens and Medical Devices
  • Cytokine multiplexing

 

 Dr David Roesti

New Chapter of ECAs OOS/OOL Guide: Guidance for sterility test failures

Dr David Roesti, Novartis

  • General Procedure
  • Timelines
  • Obvious laboratory failure prior to completion of the test 5
  • Laboratory invstigation – fro, ID up Conclusion
  • Level II Full scale investigation
  • Batch disposition and health authority notification