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Live Online Conference: Rapid Microbiological Methods and Mycosplasma Testing

11 November 2020

Objectives

This Live Online 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 Live Online Conference 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 Live Online 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 11.11.2020: RTRT: A Reality Check in the Small and Large Molecule World

09.00 - 09.45 h
Key Note: RTRT: A Reality Check in the Small and Large Molecule World
Dr Lorenz Liesum, F. Hoffmann-La Roche

09.45 – 10.30 h - Validation of Alternative Methods: the Perspective from the European Pharmacopoeia
Emmanuelle Charton, EDQM

10.30 – 11.00 h - From Visual Counting to Automation of Water Monitoring with the Growth Direct
Johannes Oberdörfer, Boehringer Ingelheim

11.00 – 11.15 h Break

11.15 – 11.45 h - Validation and Implementation of an Automated Colony Counter for Product Bioburden Testing
Dr Sven M. Deutschmann, Roche Diagnostics

11.45– 12.15 h - Non-inferiority Testing for RMM Validation: Two use Cases
Dr Viviane Grunert da Fonseca, Roche Diagnostics

12.15 – 12.45 h - Questions and Answers

12.45 – 13.45 h Break

13.45 – 14.15 h - Development and Validation of a Rapid Sterility Test using BacT/ALERT Dual T
Dr Marja Claassen, MSD

14.15 – 14.45 h - Validating a Rapid Sterility Test: Practical Strategies to Ensure Regulatory Compliance
Dr Michael Miller, Microbiology Consultants

14.45 – 15.15 h - Rapid Microbial Test for Short Shelf Life Pharmaceuticals
Kai Nesemann, Sartorius

15.15 – 15.30 h Break

15.30 – 15.45 h - A Real-time PCR Assay designed to fulfill Mycoplasma Detection Regulatory Requirements
Darren Bauer, Thermo Fisher Scientific

15.45 – 16.15 h - Making the Switch: the Evaluation, Implementation and Validation of bringing Rapid Mycoplasma Testing in-house to expedite Lot Release of Recombinant Protein Product 
Dr Kent Persson, Octapharma

16.15 – 16.30 h - BPOG’s framework for the evaluation, validation and implementation of alternative microbiological testing methods
Dr Sven M. Deutschmann, Roche Diagnostics

16.30 – 17.00 h - Questions and Answers

Moderation

Dr Sven M. DeutschmannRoche Diagnostics

Speakers

Darren Bauer, Thermo Fisher Scientific, USA
Product Manager.

Dr Emmanuelle Charton, EDQM, Concil of Europe, France
European Pharmacopoeia Department. Head of Division B.

Dr Marja Claassen, MSD
Senior microbiological specialist.

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.

Dr Viviane Grunert da Fonseca, Roche Diagnostics, Germany
Statistical support to the nonclinical areas of chemistry, manufacturing, and controls.

Dr Michael J. Miller, Microbiology Consultants, USA
President.

Kai Nesemann, Sartorius Labs Instruments, Germany
Global Product Manager DNA-based rapid QC-testing.

Johannes Oberdörfer, Boehringer Ingelheim, Germany
Quality Biopharmaceuticals.

Dr Kent Persson, Octapharma, Sweden