European Microbiology Jubilee Conference

24/25 March 2026, Wiesbaden/Germany

Objectives

On the occasion of the 20th anniversary of the ECA Pharmaceutical Microbiology Working Group, the European Microbiology Conference offers a topical programme with regulatory updates from the most important pharmacopoeias such as Ph. Eur. and USP and the requirements for GMP inspections in Europe and the USA. Experts from all over the world will present their experiences with modern microbiological methods and their validation. Additional highlights include a series of presentations on phage therapy and the revision of Technical Report #33 on rapid microbiological methods.

Registration

Background

Microbiological quality assurance is gaining importance with the rise of biological drugs. This includes faster testing methods for short shelf lives, viral contamination testing, new pyrogen tests aligned with 3R initiatives, and the analysis of DNA/RNA residues. Regulatory authorities now focus strongly on microbial control concepts described in product dossiers and inspected during audits. The annual European Microbiology Conference offers a platform to stay updated on challenges and share expertise. This year's anniversary conference will provide updates on the new and revised chapters of the most important pharmacopoeias, as well as insight into the expectations and experiences of GMP regulatory authorities with regard to microbiological QC and QA. In addition, speakers from laboratories and industry will present their practical experiences with new methods, their implementation and the potential stumbling blocks involved.

It has actually been 20 years since the current ECA Pharmaceutical Microbiology Working Group was founded, at that time still under the name Rapid Microbiology Methods Working Group. On 7 June 2006 the group consisting of 11 representatives from the European pharmaceutical industry and the PEI (the German Federal Institute for Vaccines and Biomedical Products) was launched at the Paul Ehrlich Institute (PEI) to focus more closely on the topic of rapid methods. At this point, we would like to remember our two founding members, Dr Thomas Montag and Thomas Mikosch, who sadly passed away far too early.

Over the years, the group continued to grow and increasingly became the preferred point of contact for all microbiological topics, questions from members and other ECA working groups, and enquiries from authorities. Therefore, in 2015, the ECA and the Advisory Board decided to rename the group the ‘Pharmaceutical Microbiology Working Group’ and to expand its remit and activities. The group's goal is now to offer advice on all topics related to pharmaceutical microbiology, publish helpful guideline documents, and much more.

To mark its 20th anniversary, we incorporate the European Microbiology Conference, which has been held annually since 2008, into a special framework of PharmaCongress & PharmaTechnica 2026. This results in additional benefits for you as a participant, speaker and exhibitor:

For exhibitors:  

  • Approx. 1100 participants on site
  • The opportunity to invite visitors to the exhibition free of charge
  • Free tickets for customers
  • The opportunity for live demos on stage
  • Special offer: 5 free of charge employes as stand personnel

For Congress participants:

  • Special offer: Book one participant and register three (from October to December) or book one and register two (January-March)
  • You will have access  to 8 conferences and the choice out of around 100 Presentations – create your own programme
  • More than 1000 colleagues for networking and knowledge exchange
  • Live demos
  • 120 Exhibitors to get up to date with developments in technology and services
  • Included food and beverage and a social event

We look forward to welcoming you in Wiesbaden.

Dr. Sven M. Deutschmann, Roche
Chairman of the ECA's Pharmaceutical Microbiology Working Group

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

Moderators

Dr Sven Deutschmann, Roche, Chair ECA Microbiology Working Group
Dr Michael Miller, Microbiology Consultants

Detailed Programme

Tuesday, 24 March 2026

Module 1: Phages Therapies

New Developments in Quality Control of Phage Therapy Medicinal Products (PTMPs)
Dr Oleg Kruth, PEI - German Federal Agency for Vaccines and Biomedicine
Dr Pieter-Jan Ceyssens, Sciensano

  • The two recent General Chapters on PTMPs, the first one released in 2024 and the second one (on potency) planned for 2026.  
  • Practical experience in the quality control of therapeutics phage API, produced for magistral use in Belgium
  • Phage-specific quality aspects in the production of APIs, such as induction of prophages and intrinsic genetic heterogeneity

Phage Therapy, a more Industrial View
Dr Frederique Villevie, 5 QBD-Biotech

Module 2: Modern and Alternative Microbiological Methods

PDA Technical Report #33
Dr Michael Miller, Microbiology Consultants

Live Demos

  • BWT

AI concepts for Environmental Monitoring trending
Emily Butterworth, Astra Zeneca

  • Automated trending reports as an alternative to manual Excel spreadsheet trending
  • Generative AI prompt development for large data set trending and assessment
  • Concept of predictive/continuous monitoring AI tool to support Aseptic manufacturing

The Generalisation and Evolution of MAT using novel immortalized Monocyte Cells (aMylc-Z)
Kazuyo Miyzaki, Mican Technologies

  • Activities for automation
  • Method development to
    • reduce the complexity of cell handling (no counting, no centrifugation)  
    • reduce the use of plastic (74% less)  
    • reduce the time to evaluation

Automated MAT with Technology for a robust MAT Assay
Dr Anaïs Legent, MAT Research

  • Existing MAT methods – limitations in terms of speed, consistency and scalability
  • Automated MAT advantages and opportunities such as improved accuracy and high throughput capacities.
  • Implementation and challenges such as cost, technology integration and regulatory approvals

Wednesday, 25 March 2026

Module 3: Authorities' Expectations and Pharmacopoeial Developments

Microbiology in Focus: Review, Inspection, and Policy Trends from the US FDA
Dr Erika Pfeiler, Valsource, formerly FDA

  • Get an update on the evolution of Agency policy and guidance priorities
  • Learn about FDA organizational updates and what they mean for application review and facility inspection
  • Explore microbiology and sterility assurance inspectional trends to proactively address compliance risks

USP Microbiological relevant Developments  
Dr Friedrich von Wintzingerode, Roche, USP Microbiology Expert Committee

EU-GMP Inspection: Inspector’s View on Microbiological Laboratory
Dr Rainer Gnibl, Government of Upper Bavaria, Germany

  • General requirements
  • Focus: Annex 1
  • Classification of background environment for sterility-test
  • Microbiological environmental monitoring

Module 4: Further Developments in Microbiology

Update of Microbiological general Chapters and Guidelines of the Chinese Pharmacopoeia 2025 Edition
Dr Sha Zu, Merck Life Science

  • Background and overview of the Chinese Pharmacopoeia
  • Update of amendments and revisions of microbiological general chapters and guidelines of the Chinese Pharmacopoeia 2025 edition
  • Harmonization with international standards and regulations
  • Other development trends in microbiological general chapters and guidelines of the Chinese Pharmacopoeia 2025 edition

Validation of an 8 Hour Exposure Time to UDAF of Settle Plates with a Diameter of 150 mm used in Environmental Monitoring
Dr Martin Falke, Vetter Pharma-Fertigung

  • EU GMP Annex 1 (9.30) and <USP 1116> limit 90 mm settle plates under UDAF to 4–5 hours.
  • Data with reference strains and Vetter isolates show 150 mm plates remain viable up to 8 hours.
  • In very low humidity clean rooms, settle plates can be exposed up to 6 hours.
  • UDAF lowers plate water content to ~24%, but growth remains unaffected.
  • Significance: Longer exposure (up to 8 hours) reduces interventions and contamination risk.

Recovery Efficiency of Contact Plates - Data from natural inoculated Surfaces
Dr Marcel Goverde, MGP  
Juliane Hornung, Labor LS

  • Understanding the requirements of Annex 1 §9.29: "supporting data for the recovery efficiency"
  • Key insights from recovery efficiency studies: focus on contact plates
  • Implications of recovery data for environmental monitoring (EM) program design and validation

The new USP chapter <1119>: Challenges in Implementation and possible Solutions
Christine Weiß, Labor LS

  • What does the new chapter demand?
  • Bioburden test performance according to chapter <1119.1>  
  • Risk-based bioburden monitoring - how to proceed with this?

Microbiological Qualification of an autonomous Clean Room UV Robot for Disinfection
Caitlin Cooke, Astra Zeneca

  • Astra Zeneca’s approach to validation (global) of the technology  
  • Application/integration into AZ clean rooms  
  • Conclusion, future and next steps - including further uses of UV light

Programme last upated: 07 November 2025

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