Sprachauswahl: DE |
EN
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

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
Dr 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
Dr Alexandra Müller-Scholz, Sartorius
15.15 – 15.30 h Break
15.30 – 15.45 h - A Real-time PCR Assay designed to fulfill Mycoplasma Detection Regulatory Requirements
Suzy Brown, 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
Moderator
Barbara Gerten, Merck
Speakers
Suzy Brown, Thermo Fisher Scientific, UK
Field Application Specialist Pharma Analytics.
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.
Dr Alexandra Müller-Scholz, Sartorius Stedim Biotech, Germany
Scientist - Applications for Molecular Biology.
Johannes Oberdörfer, Boehringer Ingelheim, Germany
Quality Biopharmaceuticals.
Dr Kent Persson, Octapharma, Sweden