OCTAPLAS Solution for infusion Ref.[27452] Active ingredients: Human plasma protein fraction

Octaplas is a sterile, pyrogen free, frozen solution of solvent/detergent (S/D) treated pooled human plasma.

The active ingredient comprises plasma proteins such as albumin, immunoglobulins, other globulins, coagulation factors, complement proteins and protease inhibitors. The content and distribution of plasma proteins in Octaplas are comparable to reference ranges for healthy blood donors, except for Protein S and alpha 2-antiplasmin. Within a mean total protein content of 57 mg/mL, albumin comprises ~50% and immunoglobulin classes G, A, and M comprise ~12%, ~3% and ~1%, respectively. Protein S and alpha 2-antiplasmin, which are labile to S/D treatment, are controlled to ensure levels in the final product of ≥0.4 International Units (IU) per mL. Plasma lipids and lipoproteins are reduced due to S/D treatment and subsequent oil and solid phase extraction.

Composition of Octaplas:

Octaplas is manufactured from human plasma collected in US licensed plasma donation centers. All plasma donations are tested for viral markers in compliance with US regulation. In addition, the manufacturing plasma pool may not contain a titer of human Parvovirus B19 DNA exceeding 10.0 IU per microliter and must have a negative result in a test for human Hepatitis E Virus (HEV) RNA by NAT PCR with a sensitivity of ≤2.5 log₁₀ IU/mL.

Each lot of Octaplas is manufactured from pooled plasma of a single ABO blood group (A, B, AB, or O). The manufacturing plasma pool is limited to 390 kg comprising 630-1,520 individual donors. Frozen plasma units are thawed and pooled. Sodium dihydrogen phosphate dihydrate is added as a buffer against increase in pH due to loss of CO₂. After filtration through a 1 µm pore size membrane, the plasma pool is treated with S/D reagents [1% tri(n-butyl) phosphate (TNBP) and 1% Octoxynol for 1-1.5 hours at +30°C (86°F)] to inactivate enveloped viruses. The S/D reagents are removed by sequential oil and solid phase extraction procedures. Glycine is added to adjust the osmolality. Plasma with glycine is applied to a column filled with affinity ligand resin intended for selective binding of prion protein (PrP^Sc). The effectiveness of this step in removal of prion infectivity from the product has not been established. After sterile filtration, the product is filled into sterile polyvinyl chloride blood bags, labeled, deep-frozen and stored at a temperature of ≤ -18°C (-0.4°F). The finished product is tested for coagulation factors II, V, VII, VIII, IX, X and XI, Protein C, Protein S, alpha 2-antiplasmin, fibrinogen and ADAMTS13.

The S/D treatment step has been validated to effectively inactivate relevant pathogenic and model enveloped viruses as summarized in Table 1.

Table 1. Virus Reduction During Octaplas Manufacture:

HIV-1: Human Immunodeficiency Virus – 1
PRV: Pseudorabies Virus
SBV: Sindbis Virus
BVDV: Bovine Viral Diarrhea Virus