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 needs to be tested for mycoplasma prior to further processing. This article will give an overview of Octapharma’s journey on replacing an out-sourced mycoplasma test with Thermo Fisher’s MycoSEQ qPCR assay. Octapharma in Stockholm sought regulatory approval for the assay that will be run in-house and hence save lead time for recombinant production. Actual resources, conditions and premises will vary between users and this will impact the process to implement the assay..
