ECA-European Microbiology Conference

• 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 

Modul 2: Modern and Alternative Microbiological Methods - Pyrogen and more 

PDA Technical Report #33 
Dr Michael Miller, Microbiology Consultants 

Application of AI within Microbiological Data Analysis 
Emily Butterworth, Astra Zeneca 

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

Modul 3: Authorities Expectations and Pharmacopoeial Developments 

FDA Microbiology Updates (Policy, Regulatory, and Inspectional Trends) 
Dr Erika Pfeiler, Valsource, formerly FDA 

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, GMP Inspector, Local Government, Germany 

• General requirements 

• Focus: Annex 1 

• Classification of background environment for sterility-test 

• Microbiological environmental Monitoring 

Modul 4: Monitoring and More 

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 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. 
   

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 

 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