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 Huiping Tu, United States Pharmacopeia (USP)

Updates on Ph. Eur. and ChP in Microbiology and Pyrogenicity
Dr Solène Le Maux, EDQM

• Pyrogenicity: phasing out the Rabbit Pyrogen Test, rFC latest updates
• Rapid Microbiological Methods: revision of Ph. Eur. 5.1.6

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
• SporeBio
• Tema

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