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

Wednesday, 25 March 2026

Module 3: Authorities' Expectations and Pharmacopoeial Developments

FDA Microbiology Updates (Policy, Regulatory, and Inspectional Trends)
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 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

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