RMM Conference Programme

Rapid Microbiological Methods Conference

10-11 December 2014, Heidelberg, Germany

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Objectives
This two day conference offers you a unique possibility to evaluate the new developments in RMM systems to extend the experiences in validation as well as implementation of these systems in pharmaceutical industry. Furthermore you will learn more about the expectations of authorities and developments in regulatory requirements. Experts will give an insight view in the routine use of RMM and furthermore, an after conference workshop will provide you practical examples and information about the use of the microbiological data.

Background
Microbial contamination poses enormous risks to pharmaceuticals and their consumers. To minimize the quality and financial risk, pharmaceutical and biopharmaceutical manufacturers collect thousands of samples for bioburden or sterility testing a year. The classic culture methods are often laborious and require long incubation times. In the field of some biopharmaceuticals, Advanced Therapy Medicinal Products and other modern products, it is often not possible to wait 7 or more days for a result. RMMs provide the ability to reduce time and costs for microbial detection and increase the safety level of the products.

In the meantime several new systems for the detection of microbial contaminants and new identification systems are available at the market or in validation. The regulatory authorities like FDA, EDQM or MHRA assist the implementation of RMMs e.g. with the revision of the related guidelines or pharmacopoeias.

Target Audience
This conference is of interest to professionals in Quality, Microbiology and Validation from

  • Pharmaceutical and Biopharmaceutical Companies
  • Contract Service and Research Laboratories
  • Government Agencies
  • Cell Culture Collections

Programme
Rapid Microbiological Methods in Pharmaceutical Manufacturing – Perspectives from the FDA
Dr Erika Pfeiler, FDA

  • FDA’s policy on the use of rapid microbiological testing methods
  • Suggested approaches to validating your rapid microbiological testing method
  • Regulatory pathways to approval of rapid microbiological testing methods
  • Case studies from FDA review of rapid microbiological testing methods
FDA Microbial Safety of Advanced Therapy Medicinal Products – The Impact of Rapid Methods
Jan-Oliver Karo, Paul Ehrlich Institut
  • Regulatory framework for ATMPs
  • Microbiological challenges and characteristics of ATMPs
  • The role of rapid microbiological methods: What do we need for ATMPs?
  • Case studies from the microbiological assessment of ATMP applications
Qualitative Detection of Microbial Contamination in cell-therapeutic processes based on real-time PCR
Kerstin Kleinschmidt, Novartis
  • Need of RMMs for microbiological quality control of cell-therapeutic processes
  • Real-time PCR as a possible alternative
  • Detection of low-level contamination possible
  • Validation concept designed
ROADMAP to PCR-Based Adventitious Agents Testing
Sven M. Deutschmann, Roche
  • Problem Statement "Current Cell-Based or Culture-Based Methods"
  • Intended Replacements
  • Long Range Implementation Plan
Validation of Milliflex Quantum for bioburden analysis and global implementation strategy
Len van Lin, MSD and Edwin van den Heuvel, Eindhofen University of Technology

dblast for rRNA Gene Sequence Analysis
Dr Wolfgang Eder, Roche
  • Identification concept of microorganisms at Roche
  • New dblast database for identification of bacteria and fungi
  • Validation of the dblast database
Identification of Single Bacteria by Micro-Raman Spectroscopy”
Dr Andrew Bartko, Battelle Institute Columbus and Joerg Dressler, PMT GmbH
  • Technical background - Raman Spectroscopy
  • Raman Spectroscopy in the micrometer scale
  • Identification of particles in the micrometer scale
  • Identification of bacteria, the spectroscopic concept
  • Technical setup for a Raman spectrometer focussing on the needs of the pharmaceutical industry
  • Discussion of field data
NGS preliminary data on Biosafety Quality Control
Emiliano Toso, Merck Serono
  • Application Strategy
  • Sensitivity and Specificity checks
  • Future perpsectives
Rapid identification of environmental bacteria by MALDI-TOF Mass Spectrometry
Dr Arnaud Carlotti, Eurofins IDmyk, France
  • 302 isolates representing 50 genera and 138 species found most frequently in routine in pharmaceutical environments were analyzed on the VITEK MS Plus system.
  • Identifications obtained were compared in each case to almost full gene16S rRNA gene sequencing data and for some cases to multilocus comparative sequencing data.
  • All results include isolates in concordance with the reference identification (Genus+species), presence or absence of the target species in the closed database, and the intra-species variability.

Short Presentation: BioTrak Applications
The Evolution to Acceptance in the Pharmaceutical Manufacturing Environment
Rocco Petrizzo, M.Sc, TSI

Biotrak – Evaluation of a Real Time System
Benoit Ramond, Sanofi Aventis

  • Biotrak a laser induced fluorescence system (LIF) capable to detect viable particles
  • What about the discrimination between viable & non-viable particles?
  • What is the scope of applications in the environmental monitoring?
  • Real time monitoring dream or reality?
  • Supportive data on the potential of Biotrak in Grades A, B, C and D from feasibility studies made within Sanofi.

Rapid Microbial Method Feasibility Studies and Implementation of the Rapid Micro Biosystems Growth Direct system for Biologics Production Process Monitoring
Dr Dominique Olyslaegers, Janssen Pharmaceuticals

  • Application of critical-to-quality(CTQ) forced ranking tool to select top three rapid microbial methods (RMM)
  • System evaluation based on vendor-supported feasibility studies and selection of favorite RMM for biologics production process monitoring
  • Approach for the Growth Direct implementation at multiple production sites for environmental monitoring, water testing and in-process bioburden testing

An Initial Evaluation of a Novel Rapid Micro Detection System
Kevin Luongo, Shire, USA

  • Assessment of Quantitative Specificity and Limit of Detection
  • Assessment of Qualitative Limit of Detection
  • Operational Observations (Ease of Use)
  • Potential Applications in the Biopharmaceutical Industry

Efficient Mycoplasma and Leptospira concentration techniques for increasing Real-time PCR sensitivity in large sample volumes
Dr Alexandra Scholz, Sartorius

  • Standard NAT methods process relatively low sample volumes which results in a lack in sensitivity
  • Devices and methods are presented for concentrating up to 70 mL of liquid samples prior PCR testing
  • Even low cell concentrations in large volumes can be detected
  • Data of samples with and without pre-concentration step are compared showing the efficiency of this method

Rapid Methods for the Microbial Safety of Blood Products - Requirements, Development and Installation in the Blood Centers Routine Setting
Dr Melanie Störmer, University of Cologne

  • Overview of current rapid methods for microbiological control of cellular products (pros and cons)
  • Authorities requirements
  • Development of rapid methods and validation
  • Challanges for the routine setting

Detection of Microbial Growth in Vials with a Gas Headspace Analyzer
Dr David Roesti, Novartis

  • Oxygen and Carbon Dioxide measurements
  • Large variety of stressed microorganisms tested
  • What happens with damaged vials?
  • Is the method advantageous in terms of time to results?