Manufacturing & Pathogen Safety

Cutaquig manufacturing and purification process1-3


Pathogen safety explanation chart

Cutaquig contains all 4 subclasses of IgG, with a percentage distribution equivalent to the one found in normal plasma.

  • Cutaquig is made from large pools of donated plasma which go through a rigorous purification process for the inactivation and removal of viruses
  • Other precautions against viral transmission include: selection of plasma donors, screening of donations and plasma pool, as well as final product testing for viruses
  • Cutaquig is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with a Solvent/Detergent (S/D), and incubation at low pH.

Viral removal and inactivation1

Cutaquig manufacturing process shows significant viral reduction within in vitro studies.

Production StepIn vitro reduction factor [log10]
Enveloped VirusesNon-Enveloped Viruses
HIV-1PRVSBVMEVPPV
Cold ethanol fractionation≥ 4.81≥ 6.28≥ 7.13≥ 7.13≥ 6.53
S/D treatment≥ 4.935.23≥ 6.77n.a.n.a.
pH 4 treatment≥ 4.33≥ 6.716.715.07< 1*
Global reduction factor≥ 14.07≥ 18.22≥ 20.61≥ 12.20≥ 6.53

*Not calculated for global LRF.
HIV-1: Human Immunodeficiency Virus – 1; PRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV); SBV: Sindbis Virus model virus for Hepatitis C Virus (HCV); MEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19; PPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV).

Review the clinical efficacy and safety of cutaquig here.

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References:
  1. Cutaquig® (Immune Globulin Subcutaneous (Human) – hipp), 16.5% solution. Full Prescribing Information. Octapharma USA, December 2019.
  2. Octapharma, Data on File.
  3. Buchacher A, Kaar W. Intravenous immunoglobulin G from human plasma– purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley & Sons, Inc; 2013.