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3rd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Event
21 November 2022
Background & Objectives
Mycoplasma contamination of biopharmaceutical products (also known as biologics or large molecules) resulting from cell culture contamination in the manufacturing process poses a potential health risk to patients. Mycoplasmas can affect virtually every cell culture parameter with often only minor visible effects, creating an uncontrollable environment that is undesirable in the pharmaceutical industry. Therefore, regulatory agencies require manufacturers to test their biopharmaceutical products and to ensure the absence of mycoplasmas in released products. Most regulatory agencies have issued guidelines that provide protocols for mycoplasma testing, and some give recommendations for the validation of rapid NAT (nucleic acid amplification techniques) testing methods. This satellite symposium will give you a scientifically sound introduction into the field of Rapid Mycoplasma testing with a specific focus on NAT and more specifically on qPCR methods. It includes talks, case studies as well as interactive round table discussions from users to users.
The Pre-Conference Workshop is directed to responsible personnel involved in Quality Control testing of biopharmaceuticals and biologics, e.g.:
- QC Managers
- Microbiologists and Process Microbiologists
- Analytical Experts
- Biosafety and Pathogen Safety SME’s
- Responsible Authority Employers
It is also useful for service providers, such as contract research organisations and contract manufacturers.
Pitfalls and Issues on Mycoplasma Testing According to Pharmacopoeial Requirements -
A Regulator´s View on ATMPs
Jan Oliver Karo, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines
dPCR quantified Mycoplasma Standards – a New Level of Confidence
Dr Miriam Dormeyer, Sartorius
Challenges during the Validation of an Alternative Mycoplasma Detection Method
Christiana Schnitzler, Boehringer Ingelheim
Mycoplasma Testing for ATMPs: Rapid Methods and Validation Strategies
Dr Stefanie Bayer, Labor LS
Mycoplasma Detection in Complex ATMP Matrices
Dr Jonathan Hanley, Nissui Pharma Solutions
Validation of DNA Extraction Robots - The Balance between GMP Annex 11 v. Actual Best Performance
Jo Milne, Mycoplasma Experience
Recent revision proposal of Ph. Eur.-Chapter 2.6.7 "Mycoplasmas": What is proposed to be changed and why?
Dr Sven M. Deutschmann, Roche, Member of the EP Expert Group
Alternative Adventitious Agents Detection Methods in Biopharmaceuticals: A Proposal for a Structured Best Practice Approach for their Evaluation, Validation and Implementation
Dr Sven M. Deutschmann, Chair of the Phamaceutical Microbiology Working Group
Haidy Wafy, Roche
Dr Stefanie Bayer, Labor LS, Germany. Director Molecular Development.
Dr Sven M. Deutschmann, Roche, Germany. Member of the EP Expert Group & Chair of the Phamaceutical Microbiology Working Group.
Dr Miriam Dormeyer, Sartorius, Germany. Application Scientist.
Dr Jonathan Hanley, Nissui Pharma Solutions, France. General Manager.
Jan Oliver Karo, Paul-Ehrlich Institut, German Federal Agency for Vaccines and Biomedicines.
Jo Milne, Mycoplasma Experience, UK.
Christiana Schnitzler, Boehringer Ingelheim, Germany. Senior Associate Director/Head of Laboratory Mycoplasma.
Haidy Wafy, Roche, Germany. Product and Marketing Manager.