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
  • Validation


Registration

 

Programme

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.

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

Pharmacopoeial Update
Dr Solène Le Maux, EDQM

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

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

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

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

Case Study of Validation of RMM Quantitative System
Dr Michael Miller, Microbiology Consultants

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

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

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

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

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

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

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

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

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

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

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