2nd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Workshop
Im Auftrag der ECA Academy

2nd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Workshop Im Auftrag der ECA Academy

Düsseldorf/Neuss

Seminar Nr. 17483


Kosten

11. November 2019: EUR 440,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Hintergrund

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.

Zielgruppe

The satellite symposium is directed to responsible personnel involved in Quality Control testing of biopharmaceuticals and biologics, e.g.:
- QC Director, Manager, Scientists, Microbiologists, and Process Microbiologists
- Analytical Experts
- Biosafety and Pathogen Safety departments
- Bioassay Developer
- Regulatory departments

It is also useful for service providers, such as contract research organisations and contract manufacturers.

Programm

Pitfalls and Issues on Mycoplasma Testing according to Pharmacopoeial Requirements -
A Regulator´s View on ATMPs
Jan-Oliver Karo, Paul-Ehrlich Institut (PEI)

MycoTOOL – Method Development and Generic Validation Strategy
Dr Christiana Schnitzler, Boehringer Ingelheim

Automatization of Mycoplasma detection using a new fast and easy to use molecular method
Dr Félix A. Montero Julian, bioMerieux

Comparability Study of a Real-time PCR-based Mycoplasma detection kit with the culture method according to EP 2.6.7
Diana Patzelt, Sartorius Stedim Biotech

Mycoplasma detection system and its verification
Andrej Steyer, University of Ljubljana

Summary
Dr Peter Steinhardt, Roche

Zurück

GMP Seminare nach Thema

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