Molecular design and downstream processing of turoctocog alfa (NovoEight), a B-domain truncated factor VIII molecule

Molecular design and downstream processing of turoctocog alfa (NovoEight), a B-domain truncated factor VIII molecule

Turoctocog alfa (NovoEight) is a third-generation recombinant factor VIII (rFVIII) with a truncated B-domain that is manufactured in Chinese hamster ovary cells. No human or animal-derived materials are used in the process. The aim of this study is to describe the molecular design and purification process for turoctocog alfa. A five-step purification process is applied to turoctocog alfa: prote...

Turoctocog alfa (NovoEight®) – from design to clinical proof of concept

Turoctocog alfa (NovoEight®) is a recombinant factor VIII (rFVIII) with a truncated B-domain made from the sequence coding for 10 amino acids from the N-terminus and 11 amino acids from the C-terminus of the naturally occurring B-domain. Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human- or animal-derived materials. During secretion, some rFVIII mole...

Expression of Biologically Active Recombinant B-Domain-Deleted Human Factor VIII in Mammalian Cells

A new recombinant factor VIII: from genetics to clinical use

Advances in recombinant technology and knowledge about coagulation factor VIII (FVIII) are building a platform for new therapeutic options in patients with hemophilia A. The development of turoctocog alfa, a novel, high-purity, third-generation, B-domain truncated recombinant FVIII, has been produced and formulated without the use of animal-derived or human serum-derived components, in the wake...

Turoctocog alfa: an evidence-based review of its potential in the treatment of hemophilia A

Turoctocog alfa is the first B-domain-truncated third generation recombinant coagulation factor VIII (FVIII) product. Nonclinical in vitro and animal model studies have demonstrated that turoctocog alfa has similar functional potency and hemostatic efficacy as comparator FVIII products. With respect to discrepancies in the level of FVIII concentrate in plasma of current FVIII products on compar...