Ensure 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
ParametersOctaplas
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

Quote-icon_white-background

Every lot conforms to performance and safety standards established in conjunction with the FDA. Among all FFP products, only Octaplas undergoes the FDA's lot release testing.

FDA product release specifications

ParametersOctaplas/Ph.Eur. (1646)
pH value7.0 -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

ParametersPh.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
6700591e11342f870526481251347ee6 Created with Sketch.

Octaplas is an FDA approved, solvent/detergent treated, pooled human plasma approved for multiple indications.

Read More
References:
  1. Heger A, Romisch J. Quality of OctaplasLG® based on variant plasma sources. Presented at: International Society for Blood Transfusion. 2012. [Abstract p.315).
  2. 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.
  3. Octapharma. Data on file; 2013.