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Rapid Microbiological Methods

12 November 2019

Early Bird Rebate for congress delegates: Book until 31 August 2019 and get an early bird rebate on the congress ticket.

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

Congress Keynote 12.11.2019: New ICH Q14 and ICH Q2 Revision – an industry view (Key Note Presentation at the Plenum)

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

Rapid Micro instruments: secure implementation to LIMS for data security
Kham Nguyen and Dr David Jones, Rapid Micro Biosystems

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.

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

Kham Nguyen, Rapid Micro Biosystems, USA
QC Scientist.

Dr Gerold Schwarz, Bruker Daltronics, Germany
Manager Application Support.

Jonas van den Berg, Roche Diagnostics, Germany
Validation of the Celsis-based Alternative Sterility Test.