Pathogen Safety

Plasma donors, collection centers, and donated plasma are held to high standards to assure safety

  • All units of human plasma used in fibryga manufacturing are provided by FDA-licensed blood establishments, and are tested by FDA-cleared serological tests for:1
    • Hepatitis B surface antigen (HBsAg)
    • Antibodies to Hepatitis C Virus (HCV)
    • Antibodies to Human Immunodeficiency Virus (HIV)-1/2
  • As an additional safety measure, plasma is tested with Nucleic Acid Tests (NATs) for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), HCV and HIV-1 and found to be non-reactive (negative).1  Plasma is also screened for Human Parvovirus (B19V) by NAT.The limit for B19V DNA in the mini-pool is set not to exceed 103 IU/mL
  • Only plasma that passed virus screening is used for production1

Multi-stage virus inactivation process is applied before releasing finished products for use in patients1

The fibryga manufacturing process includes a solvent/detergent (S/D) step for virus inactivation, and a nanofiltration step (Planova 20N nanofilter or Pegasus SV4 nanofilter) for virus removal.1
The mean cumulative virus reduction factors of these steps are summarized in the table.1

Cumulative Virus Reduction Factors (Log10) During fibryga Manufacture1
Production Step Virus Reduction Factor (Log10)
Enveloped Viruses Non-Enveloped Viruses
HIV-1 PRV BVDV HAV PPV
S/D treatment ≥ 5.2 6.6 ≥ 5.8 n.a. n.a.
Nanofiltration (Planova 20N)* ≥ 4.2 ≥ 6.6 ≥ 4.9 ≥ 5.2 5.3
Cumulative Virus
Reduction Factor (Log10)
≥ 9.4 ≥ 13.2 ≥ 10.7 ≥ 5.2 5.3

PRV = Pseudorabies Virus, model for large enveloped DNA viruses; BVDV = Bovine Virus Diarrhea Virus, model for HCV;
PPV = Porcine Parvovirus, model for B19V
n.a. = not applicable
* When the nanofiltration step was performed using a Pegasus SV4 nanofilter, virus reduction factors for HIV-1, PRV,
BVDV, HAV, and PPV were ≥3.9, ≥6.3, ≥5.0, ≥5.2, and 4.5, respectively. Cumulative virus reduction factors
(S/D treatment + Pegasus SV4 nanofiltration) were ≥9.0, ≥12.9, ≥10.8, ≥5.2, and 4.5, respectively.

Call-out_ICON

Octapharma was the first company to apply S/D virus inactivation in routine production. The S/D process, in conjunction with other critical steps in broader viral inactivation, has delivered a proven record of no known viral transmissions for 3 decades.2

References:
  1. Fibryga full Prescribing Information. Hoboken, NJ: Octapharma USA, Inc.; rev 2017.
  2. Data on file. Octapharma USA, Inc.