Conference: Alternative and Rapid Microbiological Methods

26/27 November 2024

Objectives

In the context of this conference, current developments in the relevant regulations and scientific methods will be presented and, in addition, experiences in the implementation and validation of alternative and rapid methods will be reported. It will cover applications for in-process control as well as those used in the context of product release. Examples of real-time or online monitoring will also be regularly covered.

This conference will provide an opportunity to discuss the latest advances in technology as well as practical aspects and concerns for meeting regulatory requirements. State-of-the-art presentations by competent speakers from the authorities as well as industrial and academic experts in the field of microbiological detection and identification will provide a comprehensive overview.

Background

Scientific progress in the field of cell and molecular biotechnology has led to the rapid development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products. Against this background, the safety of these new technologies, products and applications is becoming increasingly important. An important issue in the context of risk assessment and safety is contamination with microorganisms and mycoplasmas and their detection, prevention and control using rapid and appropriate methods.

Target Audience

This conference is of interest to professionals from

  • Biotechnological & Biopharmaceutical Companies
  • Contract Service Laboratories
  • Academic Research Institutions and Organizations
  • Government Agencies
  • Cell Culture Collections
  • Supplier Detection Systems

with responsibilities in Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Research & Development, Process Development and Validation.

Download the complete programme as PDF

Click on the image to download the complete conference programme as PDF.

Programme

Conference Registration

Register Now

Moderation

Dr Michael Miller, Microbiology Consultants
Dr Ulrich Herber, Charles River Laboratories, Board Member of the ECA Pharmaceutical Microbiology Group

Detailed Programme

Tuesday, 26 November 2024

Key Note on 26 November: The Promise and Challenges of In Vitro and In Silico Models in Drug Development
Dr Julia Schüler, Charles River Laboratories
The presentation will highlight important developments in the drug development technology landscape influenced by the concept of 3R and the evolving legal landscape. General characteristics of the different applications, their translational relevance as well as adoption drivers will be discussed. Case studies from oncology drug development will help to elucidate these trends and their impact on future processes.

European Pharmacopoeial Update
Dr Solène Le Maux, EDQM

  • Exploring a certification system for the validation of alternative rapid microbiological methods
  • Review of the general chapter 5.1.6. Alternative methods for control of microbiological quality currently under revision
  • Updates on the revision of general chapter 5.1.9 Guidelines for using the test for sterility

Evaluation of the New Generation of Solid Phase Cytometry as a Very Rapid Microbial Test of Cell and Gene Therapy Products
Dr Kirsten Høstgaard-Jensen, Novo Nordisk

  • Introduction to the necessity of a rapid microbial test of Cell and Gene Therapy Products
  • Evaluation of the new generation solid phase cytometry platform
  • Data and procedure for sample preparation for Cell and Gene Therapy products
  • Current validation/development data of a new generation solid phase cytometry as a rapid microbial test of Cell and Therapy Products
  • Evaluation of the new generation solid phase cytometry platform as a rapid microbial test for Cell and Gene Therapy products
  • Conclusions

Rapid Sterility Testing by NAT Method targeting RNA instead of DNA
Yotaro Yamamoto, Fujifilm

  • Rapid sterility testing using RT-qPCR
  • Multi-assay to detect RNA from bacteria and fungi
  • Complete assay within approximately 5 hours
  • Extraction and purification of RNA using magnetic particle method
  • Includes a pretreatment step to remove and inactivate nucleic acids derived from dead organisms, reagents, and the environment

Proposal of the New Rapid Sterility Test for Regenerative Medicine Using qPCR
Akari Teramoto, Shimadzu Diagnostics

  • Regenerative medicine products are characterized by short shelf life, so rapid testing is required
  • We developed the PCR reagent to detect microbial nucleic acids with substantially reduced microbial background
  • This PCR reagent provides highly sensitive, targetspecific detection of a wide range of microorganisms, even in the presence of cells
  • At this conference, we will present the results of our evaluation of test systems using PCR reagents we have developed

Rapid Non-Destructive Growth-based Microbial Testing for In-Process Bioburden of Continious Manufacturing Lines
Philip Junker Andersen, Intubio

  • What is growth-based rapid microbial testing
  • Why does it matter for continuous manufacturing of pharmaceuticals
  • Why is it important for pharmaceutical microbiology to identify the contaminants
  • What is the current status of rapid growth-based methods for GMP use

High Throughput Sequencing, a Rapid Method for Safety Analysis in Pharmaceutical Manufacturing
Dr Thomas Bovbjerg Rasmussen, Novo Nordisk

  • We have developed an automated HTS method to test for presence of contaminating virus, bacteria and fungi in unprocessed bulk samples as well as Cell based ATMPs
  • The method handles both cell free sample types as well as sample types with a high titer of e.g. mammalian cells
  • Both the wet lab process and bioinformatic analysis pipeline are automated running in a hands-off fashion
  • Data from development, robustness and validation will be presented as well as the bioinformatic pipeline

Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing
Sophie Drinkwater, Veolia

  • Introduction to Solid-Phase Cytometry and applications in pharmaceutical microbiology
  • Summary of feasibility assessment and outcomes
  • Application and suitability assessment of technology to current processes
  • Outline of further work and challenges faced

How to Validate Non-CFU RMMs and Guidance on Setting New Acceptance Levels
Dr Michael Miller, Microbiology Consultants

  • Discuss what a non-CFU signal is and why it may not be directly compared with the traditional CFU
  • Guidance on how to validate non-CFU RMMs and show comparability with existing methods
  • What statistical methods are appropriate
  • How would you set new alert and action limits

Wednesday, 27 November 2024

Key Note on 27 November: Trends & Challenges for the Development & Testing of Biotech Drug Products
Prof Dr Hanns-Christian Mahler, Chief Enablement Officer (CEO), ten23 health

Strategy for Accelerated Implementation of New Technologies (SAINT) : Roche's Post-Approval Change Program for Control System-Updates of Biologics
Dr Christina Heinlein & Dr Sven Deutschmann, Roche

  • Introduction - Technologies and Methods
  • Description of Post Approval Change Program
  • Challenges for Implementation

Digitalization of Environmental Monitoring in a New Facility
Alexandra Wagner and Martin Brandl, Daiichi
Susan Cleary, Novatek

  • System /Hardware installation and validation
    • Process mapping and process definition
    • Digitalized Facility PQ
    • System and hardware use
    • Trending and state of control / Handling of Out Of Specification Results

Microorganism Verification Testing of an Alternative Rapid Microbial Method
Meghan Provenzano, Veolia

  • Outline of testing according to USP <1223> and EP 2.6.12 and EP 2.6.13
  • Data showing correlation to traditional plate counts with an alternative method
  • 11 typical microorganisms (bacteria, yeast, and mold) were tested in conjunction with a mixed culture
  • Demonstrate how to determine the LOD and LOQ when performing alternative method testing

Applications of Whole Genome Sequencing for Microbial Quality and Contamination Control
Dr Prasanna Khot, Charles River Laboratories

  • Overview of wet lab and bioinformatics workflows for microbial Whole Genome Sequencing
  • Considerations to operationalize wet lab and bioinformatics workflows under a Quality System
  • Examples of how Whole Genome Sequencing is used for microbial quality control (Strain Identity), contamination control (Strain Typing) and product risk assessment (Gene Detection)
  • Potential and challenges of using Whole Genome Sequencing for detecting low bioburden microbial

Lessons Learned from Feasibility of MOLDS on Maldi-TOF, What to Consider for Validation and Implementation in Routine
Marie-Laurence Baille, MSD

  • Feasibility on panel of 10 molds included impact on Maldi results by using different parameters
  • Use of IDFP and TSA media
  • Culture incubation time on maldi results
  • Method EDT vs EX with and without MBT FAST Shuttle
  • Impact of use of additional database like MSI
  • Comparison against Microseq , ITS sequencing and Westerdijk identification

What are the Benefits of the Real Time Colony Counting in Microbial Analysis?
Dr Thomas Alexandre, Interscience

  • ScanStation: a smart incubator
  • 21 CFR PART 11 compliant software
  • Application fields
  • Data from the lab
    • Pharmacopeia pure strains analysis
    • Environmental monitoring
  • Conclusion

Feasibility Study of the 3P Station, an Automated Environmental Monitoring System
Annalena Tegethoff, Novartis

  • Functionality of the 3P Station
  • Feasibility Study
  • Used Microorganism
  • Accuracy, Precision, Linearity
  • Hold Time
  • TTR
  • Results
  • Potential use

Strategy to Handle Low Viable Particle Count in Grade A Environment with an Advanced BFPC
Dr Svetlana Kiseleva, Plair

  • The presentation will cover a study with newly released bio-fluorescent particle counter, which combines real-time detection with advanced laser technology and traditional active air sampling method
  • This study covers a parallel phase study in controlled environment close to ISO5/Grade A, where real-time viable particle counts (AFU) and colony forming units
  • (CFU) are compared
  • The objective of this presentation is to provide more understanding between the relationship of AFU generated by BFPC and CFU, in order to define the actions to be taken in response to alarms
x