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| Image created by Dr. Michael J. Miller |
The European Microbiology Conference & Workshop (https://www.microbiology-conference.org) is less than a month away (June 25-27 in Munich, Germany). The conference offers a variety of topics from contamination control strategies to alternative and rapid methods. The pre-conference workshop, "Next Generation Sequencing (NGS)," will address the existing and announced relevant regulations and experiences with NGS.
Highlights for the microbiology conference include:
- Pharmacopoeial Developments – From alternative Testing and Modern Methods
- Contamination Control – Monitoring, Disinfection and more
- Method Validation and Interpretation of Results
- Monitoring – Challenges with Temperatures and more
- Endotoxin and Pyrogen – USP, Ph.Eur. and Chinese Pharmacopoeia
- Bioindicators
The conference agenda is as follows:
Overview and Future Plans of the USP Rapid Microbiological Methods Subcommittee, Dr David Roesti, Novartis
- General overview of the RMM chapters under drafting
- General principles of the revised <72> and <73> chapters
- Drafting and reviewing process within the USP microbiology expert committee
Revision of Technical Report 33 – Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods, Dr Michael Miller, Microbiology Consultants
- Understand what’s new in the 2024 Technical Report and how it compares with current regulatory and pharmacopoeia guidance
- Review new recommendations for validation and statistical analysis
- Provide instruction on how to apply the guidance for short-life products and ATMPs
Remediation of Contaminated Protein A Chromatography Resin: Case Studies from Biophorum Members, Robin De Scheemaeker, Sanofi
- General overview of the challenges associated with protein A chromatography resins necessitate the development of effective sanitization approaches capable of addressing routine maintenance and responding to bacterial contamination events.
- Review of case studies from different Biophorum members:
- Sanofi Case study: Upscaling a Peracetic Acid cleaning method for protein A chromatography resin for application as a non-routine cleaning method involving PAA solution to remediate a column contamination.
- Other Biophorum case studies - TBD
Use of Physics-Methods for Contamination Control (Space-Charge Electret / Nanoflashing), Jeanne Moldenhauer, Excellent Pharma Consulting
- New physics-based technologies provide advantageous methods of contamination control without the disadvantages of many current systems
- Identification of a new phenomenon that occurred in nature, that can now be used on demand and in a controlled fashion to inactivate microorganisms, viruses, and pollen
- Presentation of real data from international laboratories and sites showing the effectiveness of this technology
- Discussion of other potential applications
Contamination Control Strategies for Pharmaceutical Grade Water systems: Keeping it Clean and Preventing Biofilms, Dr Michael Miller, Microbiology Consultants
- Review most common water systems, designs and microbial specifications
- Identify design flaws and maintenance issues that lead to contamination and biofilm
- Provide recommendations for gaps with a focus on contamination case studies
A Disinfectant Field Trial that Meets Annex I Guidance, Jim Polarine, Steris Corporation
- A field trial of biopharmaceutical disinfectants - a component for a CCS
- Ready-to-use quaternary ammonium disinfectant and a hydrogen peroxide/peracetic acid sporicide used to control bioburden in a new cleanroom after construction.
- Impact of material flow, engineering controls, supplies and operating procedures
- EM Data evaluation and synopsis
Taxonomy, Nomenclature, Genealogy of Type Culture Strains, Miriam Guest, Charles River Laboratories
- Understanding the use of test strains in QC Micro
- Variation in recommended test organisms in the Pharmacopoeia
- Understanding the importance Taxonomy and Nomenclature
Facts or Fake? Interpretation and significance of microbiological test results, Dr Frank Mertens, Saercon
- (In-)Accuracy of microbial count
- Definition of specifications and limits
- Some general challenges for identification methods
Primary Validation of Flow Cytometry as Online Bioburden Monitoring, Dr Jürgen Illerhaus, BWT
- Presentation of the method and its applications
- Fundamental questions for RMMs... What do we really measure and how can the data be interpreted?
- Primary validation as the basis for further validation
EM Incubation Temperature – a View on a Dilemma for a QC Micro Lab, Dr Hans Joachim Anders, Novartis
- Requirements - How useful are the guidelines?
- Monitoring or release criteria?
- Audit experiences
- Thoughts on the choice and validation of an incubation regime
- Results of comparative studies
Fact Checking On The Behavior Of Environmental Microbial Organisms In A Single Temperature Incubation Regime, Laurent Leblanc, bioMérieux
- Overview of the regulatory landscape
- Common incubation practices and microorganisms recovery challenges
- Presentation of the “One media / One temperature” initiative
- Result of an exploratory study of the impact of incubation temperature in the 30-35°C range
USP Updates on Bioburden, Endotoxins and Sterility Assurance/Microbial Control, Marsha Steed, JYA/Steed MicroBio
- General principles of <1119> Bioburden Monitoring and <1119.1> Bioburden Test
- General principles of <86> Bacterial Endotoxins Test Using Recombinant Reagents
- Sterility Assurance and Microbial Control Subcommittee Updates
Latest Progress of Pyrogen/Endotoxin Test in Chinese Pharmacopoeia, Dr Qing He, National Institutes for Food and Drug Control
- A brief introduction of NIFDC and CP
- Development and requirement of pyrogen/endotoxin test in CP
- Latest progress of pyrogen/endotoxin test based on 3Rs in CP
Effect of Container Types and Material on Endotoxin and ß-Glucan Recovery, Dr Bernhard Illes, Microcoat
- Introduction to endotoxin masking
- Understanding of container material (inert vs. influential) contribution to reduced endotoxin recoveries
- Case studies with container dependent endotoxin recovery in drug formulations and of 1-3-ß-D-Glucans
- Strategies to discover and prevent the influence of container effects
Sterilization Science; a Positive Biological Indicator (BI) Result at the End of the Proper Incubation Time: How Managing It, Luisa Bernuzzi, Mesa Labs
- ISO and the USP expectations for a positive BI result
- What to do if the identified orgamism is a BI organism
- What to do if not
- Conclusions and root cause analysis
A summary of the pre-conference NGS workshop agenda is as follows:
Draft Ph.Eur. 2.6.41 – Content and Comments, Dr Sven M. Deutschmann, Roche and Dr Oleg Krut, PEI
Revision (R2) of Guideline ICH Q5A on Viral Safety Evaluation of Biotechnology Products, Dr Astrid Schwantes, PEI
Use of NGS to Identify Relationships in the Legal Context of Food Safety Controls, Coen van der Weijden, Netherlands Food and Consumer Product Safety Authority
GMP-Compliant Analysis of NGS Data for Detection of Contaminants, Identification of Bacterial and Fungal Strains, and Typing, Dr Stefan Emler, Smart Gene
NGS Strategies from Sample to Report for Microbial Identification and Viral Contamination Detection in Pharma, Caroline Rosseel, Thermo Fisher Scientific
Implementing Next Generation Sequencing technology Under GMP, Snehit Mhatre, Eurofins
The way NGS is Shaping the Future of Food-Borne Outbreak Investigations in the Netherlands, Charlotte Verbart, Netherlands Food and Consumer Product Safety Authority
Bacterial community structure and dominant species in pharmaceutical manufacturing water revealed by high-throughput sequencing, Saori Shikama, Takeda
Case Studies, Data and Experience on NGS, Doug Botkin, Charles River Laboratories
Possibilities of NGS in virus safety in accordance to ICH Q5a R2, Anna Liznar, Pathoquest