Setting Up a Rapid Mycoplasma Assay to Support Recombinant Protein Production

Octapharma AB (OAB) in Stockholm, Sweden, is the site for Nuwiq human recombinant factor VIII (FVIII), production. The drug is produced in a human cell line cultured in a perfusion bioreactor using a closed system (to minimize contamination)
and proprietary serum-free medium without animal-derived components.

In accordance with regulatory guidelines, cell banks and cell cultures used for production of biological products must be free of mycoplasma. Traditional mycoplasma testing is a growth-based method that represents a significant bottleneck in quality control (QC) testing, and it is expensive and cumbersome. Consequently, many companies outsource this testing, which can add to the turnaround time.

In 2014, the mycoplasma project was established at OAB’s plasma quality department. The mycoplasma project team investigated alternatives to growth-based mycoplasma testing for bulk-harvest material. The department performs polymerase chain reaction (PCR) testing of donor plasma on two million samples annually and holds extensive experience and knowledge with PCR method development. To meet those sample processing demands, a new laboratory
space was established requiring new equipment and qualified instruments.

The project team evaluated whether to use a commercially available mycoplasma assay or to develop an in-house assay.