Step one

Donor Screening1

Donor antibody screening for hepatitis B, hepatitis C, and HIV infection. Plasma pools tested for HBsAg, HIV and NAT tested for HBV, HIV, HCV, HAV, HEV, and ParvoB19.

Step two

Pooling & Viral Immune Neutralization2

Immune neutralization of non-enveloped viruses and reduction of components linked to TRALI

Inactivation of non-enveloped viruses by pooling and immune neutralization
Standardized levels of neutralizing antibodies in the plasma pool minimize the risk of transmitting non-enveloped viruses (e.g., HAV, parvovirus B19, HEV).1

  • Plasma pooling1: Dilution of any initial viral load.
  • Immune neutralization2: Antibodies neutralize viral particles.
  • Chromatography: (Prion Reduction)
  • NAT testing1: Viral levels below thresholds.

Log reduction factor of Octaplasma® (log10)5
Adapted from Octapharma data on file.

Step three

1 µm filtration

Removal of allergens and components linked to TRALI.

Filtration steps reduce allergens and cell debris.
Standardized levels of neutralizing antibodies in the plasma pool minimize the risk of transmitting non-enveloped viruses (e.g., HAV, parvovirus B19, HEV).1
Significant reduction of allergens
Elimination of TRALI

Step four

S/D pathogen Inactivation1

Inactivation of enveloped viruses.

Inactivation of enveloped viruses by S/D treatment
The World Federation of Hemophilia states:

“Solvent-detergent treatment is the current gold standard for safety from the highly infectious enveloped viruses, and should be seriously considered as the option of choice when assessing products.”3

Inactivation of enveloped viruses by S/D treatment

"Solvent-detergent treatment is the current gold standard for safety from the highly infectious enveloped viruses..."3

 

S/D Plasma Benefits

"Solvent/detergent treatment is gentle on plasma proteins while effective in eliminating enveloped viruses."2

Enveloped Viruses

Solvent/detergent reagents irreversibly disrupt the lipid membranes of all enveloped viruses (e.g., SARS-CoV-2, HIV, HBV, HCV, HGV, and CMV).4

Log reduction factor of Octaplasma® (log10) 5

Step five

Ligand Chromatography1

Remove potential prions

A ligand column has been included into the production process of Octaplasma® in order to specifically remove prions. This safety measure is considered effective for removing the infectious agent causing vCJD, if present in plasma

Octaplasma® also undergoes multiple size exclusion filtration steps resulting in complete leukocyte removal without activating the leukocytes. These measures have demonstrated a potential to clear prions using an animal model of the agent causing vCJD.

Step six

0.45 & 0.2 µm filtration1

Removal of bacterial and parasite pathogens.

Step seven

Sterile, standardized plasma units for transfusion

Standardization of Plasma Protein Levels in Octaplasma®

ADAMTS13 Levels in Octaplasma® are Comparable to FFP.9​

Significance of ADAMTS13:

ADAMTS13, a von Willebrand factor-cleaving protease, is important for regulating blood clot formation by sealing off damaged blood vessels and preventing further blood loss.

CMV: cytomegalovirus; DHBV: duck hepatitis B virus; FFP: fresh frozen plasma; HAV: hepatitis A virus; HBsAg: hepatitis B surface antigen (Australia antigen); HBV: hepatitis B virus; HCV: hepatitis C virus; HEV: hepatitis E virus; HIV: human immunodeficiency virus; HGV: hepatitis G virus; NAT: nucleic acid amplification testing; ParvoB19: parvovirus B19; SD: standard deviation; S/D: solvent detergent; TRALI: transfusion-related acute lung injury; VWF-MM: von Willebrand factor multimers; vWF:RiCo: von Willebrand factor – ristocetin cofactor; WNV: West Nile virus;

  1. OctaplasmaTM Product Monograph, October 31 2022
  2. Heger A, Kannicht C, Römisch J, Svae TE. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sang. 2007 Apr;92(3):206-12.
  3. Farrugia, Albert. Guide for the assessment of clotting factor concentrates for the treatment of hemophilia. Montreal: World Federation of Hemophilia 9 (2003).
  4. Biesert L, Suhartono H. Solvent/detergent treatment of human plasma–a very robust method for virus inactivation. Validated virus safety of OCTAPLAS. 1998;74 Suppl 1:207–212. doi: 10.1111/j.1423-0410.1998.tb05474.x.
  5. Data on file. Octapharma Canada Inc., 2021.
  6. Blood Products Advisory Committee. Issue Summary: 104th Meeting. September 20, 2021.
  7. Data on file. Octapharma Canada Inc., 2021.
  8. Heger A, Römisch J, aet al. A biochemical comparison of a pharmaceutically licensed coagulation active plasma (Octaplas) with a universally applicable development product (Uniplas) and single-donor FFPs subjected to methylene-blue dye and white-light treatment. Transfus Apher Sci. 2006;35(3):223-233.; Data on file, Octapharma Canada Inc.
  9. Lawrie AS, Green L, Canciani MT, et al. The effect of prion reduction in solvent/detergent-treated plasma on haemostatic variables. Vox Sang. 2010;99(3):232-238.
  10. Yarranton H, et al. Transfus Med. 2014;14(1):39–44.
  11. Heger A, Kannicht C, Römisch J, Svae TE. Normal levels of ADAMTS13 and factor H are present in the pharmaceutically licensed plasma for transfusion (Octaplas®) and in the universally applicable plasma (Uniplas) in development. Vox Sang. 2007 Apr;92(3):206-12.