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

	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
	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
	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
	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 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
	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
	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
	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

European Microbiology Conference

on 6 - 7 May 2020

Highlights

Objectives

Background

Target Audience

Moderator

Programme

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

Current activities with relevance to microbiology

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

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

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

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

Growth Direct System Experiences

Microbial control in Downstream of biopharmaceutical manufacturing

Continuous microbial air monitoring for aseptic filling lines

Case Study - Comparison of Monitoring Systems

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

Determination of Pyrogens from Medical Devices/MAT Multiplexing

Perfomance Testing for Membrane Filters

Pyrogen Detection on cellular prepartions and other short shelf life pharmaceuticals

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

The new ECA OOS/OOT Guide on Endotoxin Testing

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