Programme

Highlights

  • The Swarming Dilemma
  • Single Temperature Incubation – Experiences and Survey Results
  • Securing Culture Media Quality and the Critical Role of Strain Maintenance
  • Assessment of Oligonucleotides and ATP Interactions for Rapid Sterility Testing
  • Microbial Control and Remediation of Protein A Chromatography Resin
 
 

Objective & 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.

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

Detailed Programme

Module 1: Pharmacopeia Updates

Pharmacopeial Updates Ph.Eur., USP and ChP Part 1
Dr Shihong Ma, National Institutes for Drug Control (NIDC)
TBN, EDQM, invited
TBN, USP, invited

Module 2: Rapid Microbiological Methods

Automating Rapid Microbiological Method (RMM) Validation with Ready-to-Use (RTU) Microbial Reference Materials
Wan Li Low, ATCC, USA

Assessment of Oligonucleotides and ATP Interactions for Rapid Sterility Testing
Emily Butterworth, AstraZeneca

From Technology Evaluation to Product-Specific Validation: Implementing a Rapid Sterility Test in Pharmaceutical QC
Sarah Uhl, Boehringer Ingelheim

Module 3: Sterilisation and More

Is your Sterilisation Validation at Risk? An Overview of Challenges related to Biological Indicators
Tiffany Bullock, Steris

Sterilisation of Artificial Organs
Jeanne Moldenhauer, Excellent Pharma Consulting

Microbial Control and Remediation of Protein A Chromatography Resin
Jan Feuser, Boehringer Ingelheim

Regulatory Requirements and Expectations on Microbiological Laboratories
Dr Frank Sielaff, Regional Authority, Darmstadt, Germany

Module 4: Gram-Negative Bacteria, Water and more

The Diversity of Gram-Negative Microorganisms in the Production Environment
Christian Scheuermann, Charles River Laboratories

Beyond CFU – Automated Enzyme Targeting Assay for Real-Time Monitoring of Bacterial Activity in WFI/PW
Murugasan Claes Nielsen, BactiQuant

Module 5: Media and Incubation

Securing Culture Media Quality and the Critical Role of Strain Maintenance
Sebastian Kiesel, Labor LS

The Swarming Dilemma
Dr Ulrich Eikmanns, PMM
Dr Karola Schühle, PMM

ECA Survey on Single-Temperature Incubation
Isabelle Hoenen, Lilly

Single-Temperature Incubation for Microbiological Environmental Monitoring (GIC A3P Microbiology)
Thierry Bonnevay, Sanofi

 

 

 

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