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 presentation 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.