European Microbiology Conference 2020

European Microbiology Conference

on 6 - 7 May 2020

Highlights

  • Regulatory Developments and Authorities Expectation
  • Contamination Control Strategy for a new Launch Product
  • Monitoring and New Methods – from Comparison up to Validation
  • Testing of ATMP – Endotoxins, Mycoplasma and More
  • MAT Multiplexing Platform
  • ECA – New OOS/OOT Guide for Endotoxin Testing

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 discuss your specific issues with speakers and other participants.

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

Moderator

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

Dr Michael Miller,
Microbiology Consultants LLC

Programme

 Steffanie Strathdee, PhD

Keynote:
Necessity is the Mother of Invention:  Why Phage Therapy is Making a Comeback in the West

Steffanie Strathdee, PhD, UCSD Department of Medicine

  • The presenter will describe her family’s personal story as it relates to the current revitalization of phage therapy
  • The presenter will briefly describe the strange history of phage therapy and why it was ‘forgotten’ in the West
  • The presenter will discuss current and future prospects for phage therapy using natural, genetically engineered and synthetic phage

 

 Dr Emmanuelle Charton

Current activities with relevance to microbiology

Dr Emmanuelle Charton, EDQM
  • Rapid methods
  • BET/rFc/MAT
  • Extraneous agents
  • others

 

 Dr Michael Ruffing

Evaluation of Next Generation Sequencing (NGS) for Adventitious Virus Testing

Dr Michael Ruffing, Boehringer Ingelheim

  • Current Regulatory Background and Activities
  • Replacing compendial Methods – Case Studies

 

 Alexandra Stärk

Definition of a microbiological contamination control strategy for a new launch product

Alexandra Stärk, Novartis

  • Relevant parameters of a microbiological contamination control strategy
  • Critical and non-critical process parameters
  • Required validation studies

 

Dr Marja ClaassenDr Pieta IJzerman-Boon

Development and validation of a rapid sterility test using BacT/ALERT Dual T

Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD

  • Development of method to enable detection of Cutibacterium acnes
  • Design of experiments for solving diminished mold detection
  • Validation of improved method according to Ph.Eur. 5.1.6 and USP<1223>
  • Innovative statistical validation approach to demonstrate non-inferiority with compendial method

 

 Dr Ulrich Zuber

Rapid Microbiological Methods for Bioburden testing of air and water and the long way towards implementation

Dr Ulrich Zuber, Roche

  • Devices for online monitoring of water and air
  • Feasibility studies
  • Steps to implementation
  • Oppportunities for RMM due to the new version of Annex 1

 

 Mike Gajdiss

Growth Direct System Experiences

Mike Gajdiss, Lonza

 

 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

 

 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

 

 Peter Huonker

Case Study - Comparison of Monitoring Systems

Peter Huonker, Early 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

Rapid detection of bacteria and fungi in ATMPs prior treatment – Validation of a qPCR-based test

Dr Kai Nesemann, Sartorius

  • Validation according to international guidelines for the implementation of alternative methods and rapid sterility (among others USP <1071>)
  • Presentation of results about sensitivity, specificity, robustness and equivalence of a qPCR detection method for total bacteria and fungi

 

 Dr Wolfgang Rudy

Determination of Pyrogens from Medical Devices/MAT Multiplexing

Dr Wolfgang Rudy, TentaMedix

  • 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

 

 Barbara Gerten

Perfomance Testing for Membrane Filters

Barbara Gerten, Merck

  • The ISO 7704 – changes and revision
  • 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

 

 Stefan Gärtner

Pyrogen Detection on cellular prepartions and other short shelf life pharmaceuticals

Stefan Gärtner, Labor LS

  • Regulatory requirements
  • Test Methods and Strategies
  • Test Interferences
  • Low Endotoxin Recovery

     
 Dr Elena Ferber

Strategies for validating nucleic acid-based techniques for testing for the absence of Mycoplasma

Dr Elena Ferber, Labor LS

  • Characteristics of mycoplasmas
  • NAT-Techniques
  • Strategies for validation/suitability tests
  • Pitfalls and practical examples

 

 Jordi Iglesias Cullell

The new ECA OOS/OOT Guide on Endotoxin Testing

Jordi Iglesias Cullell, CRL

  • OOS/OOT/Atypic versus Invalid
  • Define a OOS flowchart
  • Organizational tools for conducting Investigations
  • OOS investigation Check-List