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Rapid Microbiological Methods
12 November 2019
Objectives
This conference will review the current knowledge about developments in modern microbiological methods and mycoplasma detection strategies for quality control in biopharmaceutical manufacturing.
This one-day meeting provides the opportunity to discuss the recent advances in the area of the newest technological developments as well as practical aspects and concerns of meeting the regulatory requirements. State-of-the-art presentations from authority speakers, as well as industrial and academic experts in the field of microbiological detection and identification and mycoplasmology with particular focus on the current methodologies their implementation and validation will provide an in-depth overview.
Background
The scientific progress in the field of cellular and molecular biotechnology led to a fast development of biopharmaceuticals, tissue engineered applications and advanced therapy medicinal products (ATMPs). Against this background, the safety of such new technologies, products and applications becomes more importance. One important topic in the focus of risk assessment and safety is the contamination with microorganisms and mycoplasmas and their detection, prevention and control.
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
New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)
Dr Joachim Ermer, Sanofi-Aventis Deutschland
Head of QC Lifecycle Management Frankfurt Chemistry
RMM Validation - ECA PMWG /PEI Activities
Dr Sven M. Deutschmann, Roche
RMM Validation Guide Food – A Look to the Neighbourhood
Barbara Gerten, Merck
Evaluation and Optimization of MALDI-TOF for Identification of Filamentous Fungi
Dr Gerold Schwarz, Bruker Daltronics
Dr Prasanna Khot, Charles River Laboratories
Validation of the Celsis-based Alternative Sterility Test
Jonas van den Berg, Roche Diagnostics
Different Products require different Methods - Overview of three rapid Sterility Test Methods
Stefan Gärtner, Labor LS
A Practical Guide on how to demonstrate a significant return of investement when implementing Real-Time RMMs
Dr Michael Miller, Microbiology Consultants
PCR - Rodent Parvo Virus Testing
Dr Alexander Bartes, Roche Diagnostics
Rapid detection of bacteria and fungi in ATMP prior treatment - Validation of a Real-time PCR-based test
Kai Nesemann, Sartorius Labs Instruments
Moderation
Dr Michael J. Miller, Microbiology Consultants
Speakers
Dr Alexander Bartes, Roche Diagnostics, Germany
Senior Quality Control Manager.
Dr Sven M. Deutschmann, Roche Diagnostics, Germany
Head of Global ASAT "Adventitious Agents Testing and Alternative Microbiologica. Chairman of the Advisory Board of the ECA “Pharmaceutical Microbiology Interest Group”, Member of PDA Task Forces.
Stefan Gärtner, Labor LS, Germany
Head of Department Sterility Testing, Member ECA Mat Task Force.
Barbara Gerten, Merck, Germany
Chairwoman DIN Working Group Microbiological Food Testing incl. Rapid Methods.
Dr David Jones, Rapid Micro Biosystems, USA
Technical Services Director.
Dr Prasanna Khot, Charles River Laboratories, USA
Senior Research Scientist Microbial Solutions
Dr Michael J. Miller, Microbiology Consultants, USA
Global expert in rapid methods, validation and pharmaceutical microbiology.
Kai Nesemann, Sartorius Labs Instruments, Germany
Global Product Manager DNA-based rapid QC-testing
Dr Gerold Schwarz, Bruker Daltronics, Germany
Manager Application Support.
Jonas van den Berg, Roche Diagnostics, Germany
Validation of the Celsis-based Alternative Sterility Test.