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 presentation 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.
- Evaluation of the PCR method as an alternative to the traditional growth-based mycoplasma testing
- Laboratory set-up and instrument, software requirements
- Method development to ensure assay sensitivity required by regulators
- Validation study and regulatory submission
(Original Webcast: May 23, 2018 at 11 am ET, 8 am PT, 5 pm CET)
About the presenter
Kent Persson, PhD
Project Manager, Octapharma AB
Stockholm, Sweden
Kent Persson received his PhD at Umeå University in Sweden. During part of this time, he was also a guest scientist at University of South Carolina, Columbia, SC, USA. After completing his PhD, Kent did his postdoc at UCSF in San Francisco, CA. From there he was recruited as a Senior Scientist to the Gene expression Division at Bio-Rad Laboratories Hercules, Ca, USA. After 7 years in the USA, Kent moved back to Sweden and started working as a Senior Scientist at Biopharmaceuticals R&D for Octapharma AB in Stockholm. Kent is currently in the PCR Department, working as the project manager for the Mycoplasma project.
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