Mycoplasma Testing Programme

Mycoplasma Testing Conference
9 December 2014, Heidelberg, Germany

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Objectives
This conference will review the current knowledge about 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 for mycoplasma detection and control, 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 Mycoplasmology with particular focus on the current methodologies of mycoplasma detection, 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 mycoplasmas and its 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

Recent Advances and New Developments in Mycoplasma Control of Biologicals, Biopharmaceuticals and ATMPs
Renate Rosengarten, Mycoplasma Biosafety Services

  • PCR-based assays for mycoplasma detection: recent achievements, current trends and existing concerns
  • Current knowledge on cell culture-adapted highly fastidious cultivar strains and their detection
  • "Universal" mycoplasma culture media for rapid mycoplasma enrichment prior to PCR-based analysis
  • Pros and cons of rapid mycoplasma testing by combined culture and PCR hybrid approaches

New Data and Developments on Mycoplasma Detection
Freek Blanken, MicroSafe

NAT for Mycoplasma Detection in Release Testing according to Ph. Eur.
Holger Kühn, BioChem

  • Method Validation of in House Method
  • Real-Time vs Classical PCR approach
  • Pitfalls in Contract Testing 

Validation approach for the detection of mycoplasma by NAT method and comparability with compendial methods
Dr Renato Biiffi, Eurofins

  • Regulatory references
  • Culture and Indicator cell culture method
  • Validation approach of PCR method compared to Eur.Ph. requirements
  • Method's troubleshooting

Strategy for Designing a Multi-Primer Mycoplasma qPCR Assay for Release Testing
Henrik Salling, Novo Nordisk

  • Choosing PCR target and designing primers
  • Bioinformatic tools
  • Designing controls 
  • Assay performance

Validation approach for a rapid Mycoplasma qPCR detection method using statistical methods
Dr Pieta C. IJzerman-Boon

The Development of a Consensus Microbial Challenge Test with Acholeplasma laidlawwii to Rate Mycoplasma retentive Filters by Filter Manufacturers
Gerhard Haake, Sartorius, Stedim Biotech

Validation of a Fully-Automated PCR-Based Mycoplasma Detection Method
Dr Sven M. Deutschmann, Roche Diagnostics

  • Introduction
  • Method Validation 
  • Comparability Study

>> To the detailed programme of the RMM Conference