European Microbiology Conference

Target Audience

This conference is of interest to professionals in microbiology from

• Pharmaceuticals 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

Moderators

Dr Sven M. Deutschmann
Roche, Chair of the ECA Pharmaceutical Microbiology Working Group

Dr Michael Miller
Microbiological Consultants LLC

Axel Schroeder
Administration Manager, Pharmaceutical Microbiology Working Group

PART 1
Regulatory Updates and Pharmacopoeia Developments

The European Pharmacopoeia Unveiled: Recent Milestones and Future Directions
Dr Emmanuelle Charton, EDQM

• Bidding Farewell to the Rabbit Pyrogen Test: A New Era in Safety Testing
• The Future of Bacterial Endotoxin Testing
• Embracing Rapid Microbiological Methods
  
  

Potential Certification System for the Validation and Comparability of RMM
Dr Solène Le Maux, EDQM

• ƒContext and development
• Principles of a potential certification system
• Stakeholder perspectives and feedback

USP Bioburden, Microbial Control and Sterility Assurance Topic Updates
Marsha Steed, USP Expert Group

USP Rapid Microbiological Methods Updates
Dr Peter Nissen, NovoNordisk, USP Microbiology Expert Group

The Pyrogen/Endotoxin Test and Sterility/Microbial Test in Chinese Pharmacopeia
Dr Qing He, Chinese National Institutes for Food and Drug Control, Pharmacology Division

• Chinese Pharmacopeia (ChP) in general
• The pyrogen/endotoxin test in ChP
• The sterility/microbial test in ChP

Recent Direction of Microbiological Methods toward the nineteenth Edition of Japanese Pharmacopoeia
Dr Yutaka Kikuchi, Chiba Prefectural University of Health Sciences, Department of Nutrition Faculty of Healthcare Sciences

• Overview of microbiological methods
• Rapid Microbial Methods
• Monocyte-Activation Test

Live Biotherapeutic Products and Their Regulatory Framework in Europe and Serbia with a Focus on Microbiological Quality Assurance
Dr Milanka Setina, Biological Drug Quality Assessor, Medicines and Medical Devices Agency of Serbia

• Overview of Live Biotherapeutic Products (LBPs) and their unique role in healthcare
• European regulatory landscape for LBPs
• Regulatory perspectives on LBPs in Serbia
• Key microbiological quality considerations: purity, and contamination control

Inspection of Microbiological Quality Control Laboratories - Expectations and Findings
Dr Rainer Gallitzendörfer, GMP Inspector

• Overview of the legal framework in the EU
• Inspections - why, what and how
• Lab tour - expectations and typical findings

PART 2
Environmental monitoring

Contact News - Validating Contact Plates Methodology?
Karola Schühle, PharmaMedia Müller

• ƒ Possible pitfalls in contact sampling
• ƒ Detection of micro-organisms
• Impact of human handling
• DisinfectaIt residues

Lessons Learned from the Implementation of an Automated EM System at a Single Temperature
Niels Visschers & Jeroen van Wiik, MSD

• ƒGlobal implementation of automated EM system (3P) using single temperature
• Equipment qualification and method validation strategy- Challenges/opportunities and lessons learned of the equipment qualification will be discussed
• Detailed approach on statistical parameters for method validation, e.g. numbers replicates, selection of strains, etc.

Advances in microbial identification technologies: Focus on the BioMerieux VITEK MS Prime for field strains and molds
Melanie Braun and Marius Pfister, Labor LS

• Results and findings of a recent comprehensive identification study with the VITEK MS Prime
• Identification of molds with the VITEK MS Maldi ToF - an alternative to microscopic and molecular biological identification?
• LS-pedia - The step towards a comprehensive service offering scientific information, know-how and microbiological identification

PART 3
Alternative and Rapid Methods

Hands-On Learning on Performing Statistical Calculations for Quantitative and Qualitative Rapid Method Validation Criteria
Dr Michael Miller, Microbiology Consultants LLC

• Understand available statistical models for demonstrating comparability
• Match the appropriate statistical models with data sets shared by the presenter
• Perform the analyses and conclude whether the data demonstrate comparability
  
  

Advancing Your Product Sterility with a Holistic Sterility Test Solution
Nicolas Lelievre, Merck

• Exploring a validated rapid microbial method and understand its advantages for effective sterility testing
• Introducing a streamlined approach to digitizing sterility testing and QC data, ensuring compliance with regulatory standards, especially 21 CFR part 11
• Advanced Sterility Test Technology: Uncover the latest advancements in sterility test technology, ensuring a comprehensive understanding of cutting edge methods to guarantee product sterility
  
  

Evaluation of an Alternative Microbiological Technique Based on Microcalorimetry
Nathalie Vendur, Roche

• Feasibities studies – e.g. impact of different growth media on the TTR
• Product-specific evaluation studies
• LOD-evaluation
  
  

Mycobacteria techno roadmap from Sanofi Vaccine
Dr Thierry Bonnevay, Sanofi

• ƒGeneralities on Mycobacteria, regulations and Mycobacteria, history of mycobacteria testing
• Limitations of Ph.Eur. Method 2.6.2 Mycobacteria and their validation, all alternative than microbiological culture to Mycobacteria testing
• NAT : development validation of NAT Mycobacteria, conclusion and perspectives

Validation of a New Solid Phase Cytometry for Rapid Sterility Testing in Pharmaceuticals
Silvia Scotti, Eurofins,
Pauline Silberreiss, Redberry

• ƒ Advantage of rapid sterility testing with SPC
• Applicability of Red One™ technology (solid-phase cytometry) for a 4-day alternative sterility test
• Evaluation of criteria against pharmacopoeial standards, including a comparability study with the compendial 14-day method 14-day method

Sterility Testing of a Cell Based Product with new Development of Solid Phase Cytometry (ScanRDI)
Dr Hans Joachim Anders, Novartis

• Starting point validation of a cell-based product with pre-enrichment culture - a short method introduction
• Open topics before implementation
• Improvements regarding system setup (tablet, pictures)
• Direct detection without pre-enrichment - Overview of Cell burst method with Scan RDI
• Design and result

PART 4
Endotoxin and Pyrogen Testing

Automating endotoxin testing in a GMP environment with the PyroTec® PRO
Ole Siebenmorgen, Roche

• Why did we decide to implement an automated system for endotoxin testing?
• How was the implementation strategy?
• What is our experience with routine testing in a GMP environment?

Advancing Pyrogen Testing for Vaccines with Inherent Pyrogenicity: Development of the Reporter Cell-Based Monocyte Activation Test (MAT)
Sijai Yi, MSD

• An overview of the novel reporter cell-based MAT method and its advantages
• Validation of the reporter cell line as an effective MAT testing system for detecting a wide range of endotoxin and non-endotoxin pyrogens
• Case study review from MSD:
  • Qualification of a product-specific MAT method for vaccines with inherent pyrogenicity
  • Development of pass/fail specification strategies for MAT methods applicable to vaccines with inherent pyrogenicity

Overcoming High Viscosity in MAT product-Specific Validations
Dr Eva Kritikou, MAT Research

• Monocyte activation testing of highly viscous products
• Temperature modifications during or after cell incubation
• Product incubation duration adjustments
• pH alterations
• Alternatives for product-specific validation testing
  
  

Impact of LPS Mutants on Endotoxin Masking: Influence of Detection Systems and Sample Matrices
Dr Bernhard Illes, Microcoat Biotechnology

• ƒIntroduction to LPS mutants
• Understanding the effect of LPS structures (mutants) on the mechanism of LER
• Comparison of endotoxin detection of LPS mutants in different assay systems (LAL, rFC and MAT)
• LER investigations of different LPS mutants in DP and sample matrices

PART 5
General Microbiological Developments

Validation/Verification of Biological Methods (MLT, Sterility, BET, Assays)
Dr Jelena Novaković Jovanović, Galenika

• cAre all methods employed in biological laboratory validated using same principle?
• Suitability test for microbiological methods
• Validation of BET testing
• Validation of bioassays
• How to overcome challenges in validation/verification process

Benefits of Digitization in Sterility Testing”
Katharina Schlereth, Labor LS

• Integration of the isolator in laboratory information management systems (LIMS)
• Digitization of testing process and integration into LIMS
• Risk Reduction by digitization