Conference: Alternative and Rapid Microbiological Methods

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.

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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 and Dr Cedric Joossen, Johnson & Johnson Innovative Medicine

• 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