NUWIQ is different from rFVIII products made from hamster cell lines
FVIII Innovation at Octapharma
How NUWIQ is made
No Hamster Cell Lines, No Animal- or Human-Proteins, and No Human Albumin Used to Make NUWIQ1
NUWIQ Production
Initial steps using recombinant DNA technology to create NUWIQ production cells
1. Isolate the human DNA (gene) for Factor VIII
The first step in the production of NUWIQ, is isolating the human gene—the part of the DNA that encodes for the production of human FVIII.
2. Insert the Factor VIII gene into the nucleus of human production cell line
This gene is then inserted into a special production cell line. For NUWIQ, the production cell line is human-derived.
3. Examine, test, freeze, and store the cell line
The cell line is carefully examined, tested, frozen, and stored. It is now ready to produce NUWIQ.
NUWIQ Purification
Ongoing steps to produce NUWIQ
1. Thaw the recombinant Factor VIII production cell line
To prepare for production, the recombinant Factor VIII cell line is thawed
2. Move the production cell line into a bioreactor where they grow, multiply,
and make Factor VIII
and make Factor VIII
To begin production, the cell line is placed into specially made containers called bioreactors where they grow, multiply, and produce the FVIII protein in large quantities.
3. Separate the Factor VIII from the production cell line and then purify
Once the Factor VIII is separated from the production cell line, the FVIII is purified through centrifugation (spinning), 2 filtration steps, and 5 chromatography (separation) steps
4. Add a solvent/detergent step and a nanofiltration step to inactivate enveloped viruses and remove cell fragments.
The FVIII is then extracted and purified using 2 specialized steps to inactivate and remove any viruses that may be present:
- A solvent/detergent process to inactivate enveloped viruses (viruses that have an outer coating on them).2,3
- Nanofiltration – an advanced filtering process that can remove extremely small particles.
After purification, the recombinant Factor VIII is formulated and freeze-dried as NUWIQ
References
- Cafuir LA, Christine L. Kempton CL. Ther Adv Hematol. 2017;8(10):303–313.
- Sandberg H, et al. Thromb Res.2012;130:808-817.
- Casademunt E, et al. Eur J Haematol. 2012;89:165-176.
- Kannicht C, et al. Thromb Res. 2013;131:78-88.