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
• Validation

Programme

Key Note on 21 November: The Impact on the Revised Annex 1 for Rapid Microbiological Methods Implementation
Dr Michael Miller

Key Note on 22 November: Preparedness in pandemic vaccine manufacturing and deployment
Prof Dr Isabelle Bekeredjian-Ding

Future Revision of Ph. Eur. Chapters 5.1.6 Alternative methods for control of microbiological quality and 5.1.9 Guidelines for using the test for sterility
Dr Solène Le Maux, EDQM

New Generation of Solid Phase Cytometry for Rapid Sterility Testing of Pharmaceutical Products (under Ph. Eur chapter 2.6.1)
Dr Joseph Pierquin/Dr Silvia Scotti, Redberry/Eurofins Biopharma Product Testing

The Route to faster Bioburden and Sterility Testing with the Milliflex Rapid System 2.0
Dr Anne-Grit Klees, Merck

Rapid Micro QC Test- Ensuring Product Safety When It Really COUNTS
Johannes Oberdörfer, RMB

Physical and biological sampling efficiency for active microbial air samplers
Dr Miriam Schönenberger, MBV

Total Viable Microbial Count - Less of a Burden
t.b.a.

Use of Advanced Digital Imaging/machine Learning for Rapid Bioburden
Sophie Drinkwater, Astra Zeneca

A unique instrument combining real-time viable particle counting and traditional growth-based sampling. Validation approach and results.
Dr Svetlana Kiseleva, Plair

Alternatives and Rapid Microbiological methods and Pharmacopeias Regulation (Europe, US, Japan and China)
Dr Thierry Bonnevay, Sanofi

A Review of the Next Revision to PDA Technical Report #33
Dr Michael Miller, Microbiology Consultants LLC

Performance Study of the MaldiTof Technology in the Pharmaceutical Context
Dr Arnaud Carlotti, Eurofins/Idmyk

Next generation Pyrogen Testing Method Developed for Rapid, ELISA Free and Variety of Pyrogen Detection
Dr Tomohisa Nanao, Fujifilm

Validation of Methods for the Detection of DNase and RNase Contaminations in Pharmaceuticals and Single Use Devices
Annemarie Jordan, Labor LS

NGS Methods in Microbiology
Dr Oleg Krut, Paul Ehrlich Institute, German Federal Institut for Vaccines and Biomedicines

NGS Strategies from Sample to Report for Microbial Identification and Viral Contamination Detection in Pharma
Dr Inanc Erserim, Thermo Fisher Scientific