Keynote: Necessity is the Mother of Invention: Why Phage Therapy is Making a Comeback in the West
Steffanie Strathdee, PhD, UCSD Department of Medicine
- The presenter will describe her family’s personal story as it relates to the current revitalization of phage therapy
- The presenter will briefly describe the strange history of phage therapy and why it was ‘forgotten’ in the West
- The presenter will discuss current and future prospects for phage therapy using natural, genetically engineered and synthetic phage
Current activities with relevance to microbiology
Dr Emmanuelle Charton, EDQM
- Rapid methods
- BET/rFc/MAT
- Extraneous agents
- others
Evaluation of Next Generation Sequencing (NGS) for Adventitious Virus Testing
Dr Michael Ruffing, Boehringer Ingelheim
- Current Regulatory Background and Activities
- Replacing compendial Methods – Case Studies
Definition of a microbiological contamination control strategy for a new launch product
Alexandra Stärk, Novartis
- Relevant parameters of a microbiological contamination control strategy
- Critical and non-critical process parameters
- Required validation studies
Development and validation of a rapid sterility test using BacT/ALERT Dual T
Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD
- Development of method to enable detection of Cutibacterium acnes
- Design of experiments for solving diminished mold detection
- Validation of improved method according to Ph.Eur. 5.1.6 and USP<1223>
- Innovative statistical validation approach to demonstrate non-
- inferiority with compendial method
Rapid Microbiological Methods for Bioburden testing of air and water and the long way towards implementation
Dr Ulrich Zuber, Roche
- Devices for online monitoring of water and air
- Feasibility studies
- Steps to implementation
- Oppportunities for RMM due to the new version of Annex 1
Growth Direct System Experiences
Mike Gajdiss, Lonza
Continuous microbiological air monitoring
Dr Kai Nesemann, Sartorius
Case Study - Comparison of Monitoring Systems
Peter Huonker, Early Packaging Technology
- Application area and function
- Comparison of two monitoring systems – Valimon from ValiSys and Labwatch Monitoring from GE (Amphenol)
- Pros/Cons
Rapid microbial test for short shelf life pharmaceuticals
Dr Kai Nesemann, Sartorius
Determination of Pyrogens from Medical Devices/MAT Multiplexing
Dr Wolfgang Rudy, TentaMedix
- Endotoxin vs. Non Endotoxin Pyrogen detection in vitro
- Monocyte Activation Test as in vitro replacement of the Rabbit
- Pyrogen Test
- Pyrogens and Medical Devices
- Cytokine multiplexing
Pyrogen Detection on cellular prepartions and other short shelf life pharmaceuticals
Stefan Gärtner, Labor LS
- Regulatory requirements
- Test Methods and Strategies
- Test Interferences
- Low Endotoxin Recovery
Strategies for validating nucleic acid-based techniques for testing for the absence of Mycoplasma
Dr Elena Ferber, Labor LS
- Characteristics of mycoplasmas
- NAT-Techniques
- Strategies for validation/suitability tests
- Pitfalls and practical examples
The new ECA OOS/OOT Guide on Endotoxin Testing
Jordi Iglesias Cullell, CRL
- OOS/OOT/Atypic versus Invalid
- Define a OOS flowchart
- Organizational tools for conducting Investigations
- OOS investigation Check-List