Preserving Immunoglobulin Integrity

Octagam 10% is manufactured using well-controlled processing steps designed to be gentle and to preserve the structural and functional integrity of its immunoglobulin G (IgG)1,2

Octagam Manufacturing lab worker

Formulated to help mitigate tolerability issues in patients with ITP1,3,4

ParameterDetails

Maltose (mg/mL) – (no preservatives or sucrose)

90 (=90 mg per mg lgG)

Sodium (mmol/L)

≤30

pH

4.5-5.0

Osmolality (mosmol/kg)

310-380

Click here to access our maltose fact sheet.

Biochemical profile that resembles native IgG3

  • All 4 IgG subclasses are fully represented
  • Physiologic Fc function of IgG is maintained intact

Review the manufacturing and purification process for octagam 10%.

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References:
  1. Octapharma, Data on File. 2014.
  2. Buchacher A, Kaar W. Intravenous immunoglobulin G from human plasma– purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Hoboken, NJ: John Wiley & Sons, Inc; 2013.
  3. Octagam 10% Full Prescribing Information. Hoboken, NJ: Octapharma USA Inc; rev May 2018.
  4. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (Octagam 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359.
  5. Stein MR. The new generation of liquid intravenous immunoglobulin formulations in patient care: a comparison of intravenous immunoglobulins. Postgrad Med. 2010;122(5):176-84.