European Microbiology Conference
Im Auftrag der ECA Academy

6/7 May 2020

Barcelona, Spain

Seminar Nr. 17841

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Emmanuell Charton, EDQM
Dr Marja Claassen, MSD
Jordi Iglesias Cullell, CRL
Dr Sven M. Deutschmann, Roche
Dr Elena Ferber, Labor LS
Stefan Gärtner, Labor LS
Mike Gajdiss, Lonza
Dr Viviane Grunert da Fonseca, Roche
Peter Huonker, Früh Verpackungstechnik
Dr Pieta IJzerman-Boon, MSD
Dr Michael Miller, Microbiology Consultants LLC
Dr Kai Nesemann, Sartorius
Maria Eugenia Giribets Parra, Boehringer Ingelheim
Dr Wolfgang Rudy, TentaMedix
Dr Michael Ruffing, Boehringer Ingelheim
Alexandra Stärk, Novartis Pharma Stein
Dr Steffanie Strathdee, UCSD Department of Medicine
Dr Ulrich Zuber, Hoffmann-La Roche

Zielsetzung

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.

Hintergrund

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.

Zielgruppe

This conference is of interest to professionals in microbiology from

Pharmaceutical and Biopharmaceutical Companies
Academic Research Institutions
Government Agencies
Contract Laboratories

who are involved in

Contamination Control
Monitoring
Validation
Quality Affairs
Regulatory Affairs
Research and Development

Programm

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

Current activities with relevance to microbiology
Dr Emmanuelle Charton, EDQM

Rapid methods
BET/rFc/MAT
Extraneous agents
others

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

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

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

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

Growth Direct System Experiences
Mike Gajdiss, Lonza

Continuous microbiological air monitoring
Dr Kai Nesemann, Sartorius

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

Rapid microbial test for short shelf life pharmaceuticals
Dr Kai Nesemann, Sartorius

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

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

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

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

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European Microbiology Conference Im Auftrag der ECA Academy