Ensure Octaplas Bag-to-Bag Consistency
Minimize bag-to-bag variance
- Consistent concentrations of plasma proteins1,2
- Coagulation factor and inhibitor content consistent
with normal plasma1,2
| Product Composition1,2 | ||
|---|---|---|
| Parameters | Octaplas Mean Value (range) [N=33] |
Single-donor FFP Mean Value (range) [N=12] |
| Fibrinogen (mg/mL) | 2.7 (2.5-3.1) | 2.6 (1.9-3.6) |
| Factor II (IU/mL) | 0.92 (0.79-1.08) | 0.88 (0.77-1.18) |
| Factor V (IU/mL) | 0.81 (0.70-1.00) | 0.90 (0.73-1.50) |
| Factor VII (IU/mL) | 1.03 (0.70-1.20) | 0.95 (0.67-1.38) |
| Factor VIII (IU/mL) | 0.85 (0.60 – 1.30) | 0.76 (0.52 – 1.13) |
| Factor IX (IU/mL) | 0.94 (0.74 – 1.30) | 1.02 (0.82 – 1.28) |
| Factor X (IU/mL) | 0.93 (0.85 – 1.04) | 0.79 (0.62 – 0.99) |
| Factor XI (IU/mL) | 0.88 (0.80 – 1.00) | 1.13 (0.96 – 1.80) |
| Factor XII (IU/mL) | 1.00 (0.81 – 1.35) | 0.82 (0.45 – 1.12) |
| Factor XIII (IU/mL) | 1.01 (0.85 – 1.20) | 1.06 (0.68 – 1.69) |
| VWF:RCo (IU/mL) | 0.88 (0.72 – 1.01) | 0.89 (0.77 – 0.98) |
| ADAMTS13 (IU/mL) | 0.91 (0.75 – 1.30) | 1.24 (1.07 – 1.44) |
| Plasminogen (IU/mL) | 0.91 (0.75 – 1.03) | 0.98 (0.82 – 1.39) |
| Antithrombin (IU/mL) | 0.92 (0.74 – 1.00) | 1.06 (0.77 – 1.23) |
| Protein C activity (IU/mL) | 0.97 (0.79 – 1.10) | 0.89 (0.79 – 1.05) |
| Protein S activity (IU/mL) | 0.61 (0.50 – 0.72) | 1.03 (0.71 – 1.39) |
| Plasmin inhibitor (IU/mL) | 0.52 (0.30 – 0.64) | 1.04 (0.95 – 1.18) |
| α1-antitrypsin (mg/mL) | 1.29 (0.88 – 1.76) | 1.57 (0.98 -2.22) |
Different test methods were used for ADAMTS13, eg, commercial ELISA kit from Technaclone for octaplas and in-house FRETS for FFP. Chromogenic assay determined the α1-antitrypsin activity levels for octaplas and kinetic nephelometry quantified the antigen levels for FFP.
Standardized concentrations of coagulation factors and inhibitors3
Every lot conforms to quality and safety standards established in conjunction with the FDA. Among plasma products for transfusion, only octaplas undergoes lot release testing for factor content.
FDA product release specifications
| Parameters | Octaplas/Ph.Eur. (1646) |
|---|---|
| pH value | 7.0 -7.6 |
| Osmolality [mosmol/kg] | 320-420 |
| Sodium [mmol/L] | ≤200 |
| Potassium [mmol/L] | ≤5.0 |
| Calcium [mmol/L] | ≤5.0 |
| Citrate [mmol/L] | 15-25 |
| Phosphate [mmol/L] | 2.0-7.5 |
| Glycine [mg/mL] | 4.0-6.0 |
| TnBP [μg/mL] | <2 |
| Octoxynol [μg/mL] | <5 |
| Anti-HAV lgG [IU/mL] | ≥0.6 |
| Anti-B19 lgG [IU/mL] | ≥11 |
FDA product release specifications
| Parameters | Ph.Eur. (1646) |
|---|---|
| Factor II [IU/mL] | ≥0.7 |
| Factor V [IU/mL] | ≥0.6 |
| Factor VII [IU/mL] | ≥0.6 |
| Factor VIII [IU/mL] | ≥0.5 |
| Factor X [IU/mL] | ≥0.8 |
| Factor XI [IU/mL] | ≥0.7 |
| Factor IX [IU/mL] | ≥0.6 |
| Fibrinogen [mg/mL] | 2.0-4.0 |
| Protein C [IU/mL] | ≥0.7 |
| Protein S [IU/mL] | ≥0.4 |
| alpha 2-antiplasmin [IU/mL] | ≥0.4 |
| ADAMTS13 [IU/mL] | ≥0.7 |
References:
- Heger A, Romisch J. Quality of OctaplasLG® based on variant plasma sources. Presented at: International Society for Blood Transfusion. 2012. [Abstract p.315).
- Beeck H, Hellstern P. ln vitro characterization of solvent/detergent-treated human plasma and of quarantine fresh frozen plasma. Vox Sang. 1998;74(suppl 1):219-223.
- Octapharma. Data on file; 2013.