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Rapid Microbiological Methods and Mycoplasma Testing

20 November 2018

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

Alternative Microbiological Methods: AstraZeneca's, GlaxoSmithKline's, Johnson&Johnson's and Roche's Global Implementation Roadmap
Dr Sven M. Deutschmann, Roche / Dr Paul Newby, GSK /Philip Breugelmann, JnJ / Karen m. Capper, Astra Zeneca

  • Introduction & Overview
  • Alternative Microbial Enumeration Method(s)
  • Alternative Sterility Test(s)
  • Alternative ID-Test(s)

Microbial test automation to support plate incubation and enumeration
Lucille Plourde Owobi, Sanofi Pasteur

Present and Future of Molecular Microbial Identification – Bridging of Scientific Progress and Practical Application in Regulated Environments
Dr Jörg Peplies, Ribocon

Bringing Innovation into quality control: How a novel Isothermal mycoplasma assay changes the race
Samuel Zürcher, Certus Molecular Diagnostics

Rapid detection of bacteria in ATMP prior treatment - validation of a qPCR-based test
Kai Nesemann, Sartorius

Strategies for Rapid Sterility Testing of Gene and Cell Therapy Products
Dr Michael Miller, Microbiology Consultants

Understanding the Revised Ph. Eur. Chapter 5.1.6 and how it compares with USP 1223, PDA Technical Report 33 and Industry Best Practices
Dr Michael Miller

Modern alternative viable air monitoring in light of the new Annex 1 draft
Dr Frank Panofen, PMS

Using an alternative gene sequence for species-level identification for members of the Burkholderia cepacia complex (Bcc).
Dr Sunhee Hong, CRL

Pulse Light Decontamination
Christophe Riedel, Clearanor/Mirko Monti, Steriline

Moderators

Dr. Sven Deutschmann
Roche Diagnostics, Penzberg, Germany
Chairman ECA Rapid Microbiological Methods Working Group

Speakers

Kai Nesemann, Sartorius Lab Instruments GmbH, Germany
Junior Product Manager Microbiology.

Dr Sunhee Hong, Charles River Microbial Solutions, USA
Senior Staff Scientist.