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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

  • Available technologies to incubate and detect microscopic colonies
  • How to reduce time consuming without degrading sensitivity
  • GPT – his importance and possible pitfalls

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

  • The 16S rRNA gene as the gold standard for DNA-based bacterial (and fungal) identification, in both the academic and the industrial field
  • Dependency of regulated environments on academic resources in microbial systematics
  • Challenge of preparing high-grade and up-to-date reference data sets in terms of DNA sequence quality, taxonomy, and nomenclature
  • Progress in DNA sequencing technology and impact on productive use in microbial quality control
  • Potential of better resolving alternative marker genes (such as gyrb) and increasing relevance of whole genome sequencing in microbial identification

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

  • Isothermal amplification and real-time detection Potential uses of this technology in varied e.g. viral contaminations or rapid sterility testing

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

  • Importance of a microbial release test for mPatiens safety
  • qPCR zo detect total bacterial contamination
  • Validation approach according to EP 5.1.6 and USP <1223>

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, Microbiology Consultants

  • A holistic review of the revised chapter 5.1.6
  • How it compares with USP 1223 and PDA Technical Report 33
  • Understanding of the similarities and differences between each of the guidance documents

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

  • The issue of small batch sizes and short shelf life
  • Possible ew strategies for sample preparation and release testing
  • How helpful are Ph. Eur. 2.6.27, Eur 5.1.6 USP 1223, and PDA TR 33 
  • Considerations from the harmonized compendial sterility test and the U.S. Code of Federal Regulations

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

  • Annex 1 draft - new concepts of environmental monitoring
  • The potential to revolutionize the viable testing approaches
  • New aspects of viable air testing to the concepts of risk management, scientific data generation and data integrity including RMM

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

  • History of the Burkholderia cepacia complex
  • Burkholderia capacia complex in pharmaceutical industries
  • The importance of species-level identification for members of the Bcc
  • Phylogenetic relationships between Bcc species based on 16S rRNA gene sequencing
  • Evaluation of recA gene sequences for species-level resolution in the Bcc

Pulse Light Decontamination - Robotic Tub Decontaminating System
Christophe Riedel, Clearanor/Mario Fusi, Steriline

  • Background and history
  • technical inbformations
  • Denaturation of macromolecules (DNA, prozeins and enzymes) and the increase by effects of UV light

Moderators

Dr. Sven 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.

Speakers

Mario Fusi, Steriline, Italy
Technical Director.

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

Dr Michael J. Miller, Microbiology Consultants, USA
Global expert in rapid methods, validation and pharmaceutical microbiology.

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

Dr Frank Panofen, Particle Measuring Systems, Germany
Product Line Manager Sterility Assurance & Microbiology.

Lucile Plourde Owobi, Sanofi Pasteur, France
Scientist - Microbiology Platform.

Dr Jörg Peplies, Ribicon, Germany
Microbial quality control, computer validation.

Christophe Riedel, Claranor, France
Business Management.

Samuel Zürcher, Certus Molecular Diagnostics, Switzerland
CEO und Co-Founder.