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. 2023 Jan 26;21(5):441–451. doi: 10.2450/2023.0235-22

Table I.

Recombinant factor VIII concentrates available in Italy*

A. Standard half-life
Product brand (company) Recombinant protein Cell line Fractionation Viral inactivation Specific activity (IU/mg of total proteins) Comments
Recombinate (Takeda, Tokyo, Japan) Octocog alfa (full-length) CHO

  • mAb affinity chromatography

  • ion exchange chromatography

  • None

 >4,000 Albumin + VWF traces
Advate (Takeda) Octocog alfa (full-length) CHO

  • mAb affinity chromatography

  • ion exchange chromatography

  • Solvent/detergent (TNBP/Triton X-100/Polysorbate 80)

4,000–10,000 Protein free
ReFacto AF ReFactoAF fuseNGO (Pfizer, New York, NY, USA) Moroctocog alfa (B-domain deleted) CHO

  • Ion exchange chromatography

  • hydrophobic interaction chromatography

  • size exclusion chromatography affinity

  • chromatography (synthetic peptide, 27 amino acids)

  • Solvent/detergent (TNBP/Triton X-100)

  • nanofiltration (35 nm pore size filter)

 7,600–13,800 Protein free
NovoEight (Novo Nordisk, Bagsværd, Denmark) Turoctog alfa (B-domain truncated) CHO

  • mAb affinity chromatography

  • ion exchange chromatography

  • size exclusion chromatography

  • Detergent (Triton X 100)

  • nanofiltration (20 nm pore size filter)

 8,300 Protein free
Nuwiq (Octapharma, Lachen, Switzerland) Simoctocog alfa (B-domain deleted) HEK

  • Ion exchange chromatography

  • affinity chromatography

  • size exclusion chromatography

  • Solvent/detergent (TNBP/Triton X-100)

  • nanofiltration (20 nm pore size filter)

 9,500 Protein free
Kovaltry (Bayer, Leverkusen, Germany) Octocog alfa (full-length) BHK

  • Ion exchange chromatography

  • mAb affinity chromatography

  • metal chelate affinity chromatography

  • Detergent (Triton X 100)

  • nanofiltration (20 nm pore size filter)

 4,000 HSP70 gene Protein free
Afstyla (CSL Behring, King of Prussia, PA, USA) Lonoctocog alfa (single-chain) CHO

  • mAb affinity chromatography

  • ion exchange chromatography (4 steps)

  • size exclusion chromatography

  • Solvent/detergent (TNBP/Polysorbate 80)

  • nanofiltration (19 nm pore size filter)

 16,000 Protein free
B. Extended half-life
Product brand (company) Recombinant protein Cell line Fractionation Viral inactivation Specific activity (IU/mg of total proteins) Comments
Elocta (Sobi, Stockholm, Sweden) Efmoroctocg alfa (B-domain deleted) HEK

  • Centrifugation

  • ion exchange chromatography

  • hydrophobic interaction chromatography

  • size exclusion chromatography

  • Detergent (Triton X-100)

  • nanofiltration (15 nm pore size filter)

 4,000–10,000 IGg1 Fc-fusion protein
Adynovi (Takeda) Ruricotocog alfa pegol (full-length) CHO

  • mAb affinity chromatography

  • ion exchange chromatography

  • Solvent/detergent (TNBP/Triton X-100/Polysorbate 80)

 4,000–6,500 Random PEGylation 20 kDa
Jivi (Bayer) Damoctocog alfa pegol (B-domain deleted) BHK

  • Anion exchange chromatography

  • mAb affinity chromatography cationic exchange chromatography

  • size exclusion chromatography

  • Detergent (Triton X 100)

  • nanofiltration (20 nm pore size filter)

 10,000 Site-specific PEGylation 60 kDa, branched
Esperoct (Novo Nordisk) Turoctocog alfa pegol (B-domain truncated) CHO

  • mAb affinity chromatography

  • anion exchange chromatography

  • size exclusion chromatography

  • Detergent (Triton X 100)

  • nanofiltration (20 nm pore size filter)

 9,500 Site-specific glycoPEGylation 40 kDa, branched

Recombinant factor VIII products are listed in order of time of approval and market availability. BHK: baby hamster kidney; CHO; chinese hamster ovary; HEK: human embryonic kidney; HSP70: human shock protein 70; IgG1Fc: crystallizable fragment of immunoglobulins G1; mAb: monoclonal antibodies; TNBP: tri-n-butyl-phosphate; VWF: von Willebrand factor.