White paper: Making the Switch to In-House Mycoplasma Testing

Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines state that recombinant bulk harvest must be tested for mycoplasma prior to further processing. This presentation will give an overview of Octapharma’s journey on replacing an out-sourced mycoplasma test with an in-house mycoplasma qPCR assay. Octapharma received regulatory approval for the assay in October 2019 and plan to run in-house mycoplasma testing for lot release, hence saving lead time for their recombinant production.

The white paper will share Octapharma’s evaluation of the PCR method, as an alternative to the traditional growth-based mycoplasma testing and the process of laboratory set-up and instrument qualifications and software requirements. Finally, a summary of the method development, validation, ensuring assay sensitivity met regulatory requirements, and regulatory submission process will be presented.

Download the Document

    Please fill out the information below to request information on the products you selected. If you are already registered, or have requested a quote before, and this information will be filled out for you.

  • Please enter your first and last name.

  • Please enter the name of the company or institution you work at.

  • Please enter your mailing address.

  • Please enter the e-mail address you would like to be contacted at.

  • Please enter the phone number you would like to be contacted at.

  • The MycoSEQ Detection Assay is a fully integrated solution for real-time PCR-based mycoplasma detection that enables you to comply with regulatory lot-release requirements. Would you like a Thermo Fisher technical expert to contact you (by email or telephone) to learn more about the MycoSEQ System?


  • By submitting my personal data, to CompareNetworks, I acknowledge it will be shared with the Thermo Fisher Scientific group for processing in accordance with the Thermo Fisher Scientific Privacy Policy.

    Yes, I agree for the Thermo Fisher Scientific group to contact me by e-mail and telephone to inform me of events, products, services and promotions offered in connection which they believe may be of interest to me. I can withdraw my consent and unsubscribe at any time by e-mailing [email protected].

  • By submitting this form, you consent to American Pharmaceutical Review storing your email address and contact information, transmitting your contact information to selected trusted partners, and customizing your experience based on the data you enter. You can also stay up-to-date on the latest news, new technologies, and more delivered to your email inbox by selecting your subscription preferences on the next page.