Releasing your Biopharmaceutical Product with MycoTOOL PCR Mycoplasma Detection Kits

Sponsored by: Roche Diagnostics GmbH

Focused on:

  • Biopharmaceuticals
  • Mycoplasma
  • Quality Control

Date: 3 July


Time: 3PM London/10AM New York

BioPharma Quality Control is a balancing act. The challenge lies in maintaining the consistent and safe production of a high-quality product while at the same time meeting increasing pressure for faster output at reduced cost. Ensuring safety through accurate and sensitive testing is a critical aspect of Quality Control, and health authorities require proof that manufacturing processes and end product are free of contamination, such as Mycoplasma.

Testing for Mycoplasma contamination in fermentation steps or for product release can be a lengthy process. The Roche CustomBiotech MycoTOOL PCR Kits eliminate this potential cause of process disruption with a test turnaround time of one day, compared to the 28 days commonly needed for compendial methods, including direct culture and indicator cell cultures.

Based on the amplification of nucleic acids, MycoTOOL PCR kits allow you to detect over 140 Mollicute species with a sensitivity of less than 1 CFU/ml (for all validated species). Easy to use and compliant with regulatory requirements defined in E.P.2.6.7., MycoTOOL PCR kits deliver fast and reliable information to help increase your operational safety.

Join us for this webinar to learn how the Roche CustomBiotech MycoTOOL PCR Kits work and see the advantages they bring to optimize your Quality Control measures and support fast and confident safety decisions.

Presented by

Christina Krause,

International Product Manager

Christina joined Roche in 1991. She worked in different environments and therefore has experience in production of enzymes, research and software development of the Roche PCR systems, as well as in training & support with Roche Genome Sequencer. Since 2010 she is an Internal Product Manager in the Roche CustomBiotech team and is responsible for the Pharma QC and the enzyme portfolios.

Key Learning Objectives

  • General overview of the challenges in BioPharma QC and why mycoplasma testing is so important
  • Who is CustomBiotech and how do we support the Pharma environment
  • Understanding the MycoTOOL PCR Kits and their advantages of reliability, accuracy and speed
  • Where to find valuable information from CustomBiotech


  • TBA