2nd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Workshop

2nd International Mycoplasma qPCR Testing User Day - PharmaLab Pre-Conference Workshop

Düsseldorf/Neuss, Germany

Course No 17483


Costs

11 November 2019: EUR 440,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Background

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.

Target Group

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.

Programme

Pitfalls and Issues on Mycoplasma Testing according to Pharmacopoeial Requirements

Rapid Mycoplasma Detection – How Stochastics Can Help

Automatization of Mycoplasma detection using a new fast and easy to use molecular method

Comparability Study of a Real-time PCR-based Mycoplasma detection kit with the culture method according to EP 2.6.7

Mycoplasma detection system and its verification

Summary

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