Manufacturing and Pathogen Safety

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Octapharma has pioneered a number of safety innovations that have set the standard for the protein products industry

Octagam 5% manufacturing and purification process1-3

pathogen safety graphic

 


octagam 5% contains all 4 subclasses of IgG, with a percentage distribution equivalent to the one found in normal plasma

  • Octagam 5% 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
  • Octagam 5% is manufactured by cold ethanol fractionation followed by ultrafiltration and chromatography. The manufacturing process includes treatment with a solvent/detergent, and incubation at low pH

Validated viral removal and inactivation process

The manufacturing process for octagam 5% has been validated for its capacity to remove and inactivate both enveloped and non-enveloped viruses1

All units of human plasma used in the manufacture of octagam 5% liquid are collected in US-based Octapharma Plasma centers that are licensed by the US Food and Drug Administration (FDA). Plasma is tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV, and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).

Production Step In vitro reduction factor [log10]
Enveloped Viruses Non-Enveloped Viruses
HIV-1 PRV SBV MEV PPV
Cold ethanol fractionation ≥ 4.81 ≥ 6.28 ≥ 7.13 ≥ 7.13 ≥6.53
S/D treatment ≥ 4.93 5.23 ≥ 6.77 n.a. n.a.
pH 4 treatment ≥ 4.33 ≥ 6.71 6.71 5.07 < 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 evidence supporting octagam 5% in the treatment of adults and children with primary immunodeficiency here.

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References:
  1. Octagam 5% Full Prescribing Information. Paramus, NJ: Octapharma; rev April 2022.
  2. Octapharma. Data on file.
  3. Buchacher A, Kaar W. Intravenous immunoglobin 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.