How NUWIQ® FVIII Replacement Therapy Is Made

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NUWIQ manufacturing process

No Hamster Cells, No Animal Proteins, and No Human Albumin Used to Make NUWIQ

Nuwiq Production

NUWIQ Production

Initial steps using recombinant DNA technology to create NUWIQ production cells
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.
This gene is then inserted into special production cells. For NUWIQ, the production cells are human.
The cells are carefully examined using specific acceptance criteria.
The cells are now ready to produce NUWIQ.
Nuwiq Production

NUWIQ Purification

Ongoing steps to produce NUWIQ

To prepare for production, the recombinant Factor VIII cells are thawed
To begin production, the cells are placed into specially made containers called bioreactors where they grow, multiply, and produce the FVIII protein in large quantities.
Once the Factor VIII is separated from the production cells, the FVIII is purified through centrifugation (spinning), 2 filtration steps, and 5 chromatography (separation) steps
The FVIII is then extracted and purified using 2 specialized steps to inactivate and remove viruses that may be present:

  • A solvent/detergent process to inactivate enveloped viruses (viruses that have an outer coating on them).
  • Nanofiltration – an advanced filtering process that can remove extremely small particles and viruses.

After purification, the recombinant Factor VIII is formulated and freeze-dried as NUWIQ

NUWIQ — Proven Safe and Effective in Children and Adults with Hemophilia A.

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References
  1. Cafuir LA, Christine L. Kempton CL. Ther Adv Hematol. 2017;8(10):303–313.
  2. Sandberg H, et al. Thromb Res.2012;130:808-817.
  3. Casademunt E, et al. Eur J Haematol. 2012;89:165-176.
  4. Kannicht C, et al. Thromb Res. 2013;131:78-88.