Manufacturing and Safety

Octagam® is manufactured to preserve the integrity of IgG and has a distribution of IgG subclasses like in a normal healthy population.3,4,8,9

Providing pathogen safety for octagam®

The regulatory approved standard operating procedures for screening of donors and plasma, combined with multiple validated virus inactivation steps during the manufacturing process, provide confidence against pathogen transmission.3,4,8,9

The processes used in manufacturing octagam® have also been shown to inactivate the Zika virus.10  

There has never been a documented case of virus transmission by any octagam® infusion.

References

3. octagam®5%. Summary of Product Characteristics. May 2021.

4. octagam®10%. Summary of Product Characteristics. May 2021.

8. European Medicines Agency. Guideline on plasma-dervied medicinal products. EMA/CHMP/BWP/706271/2010. 2011.

9. European Medicines Agency. Plasma Master File, EMEA/H/PMF/000008/05/AU/002.

10. Kuhnel D, et al. Inactivation of Zika virus by solvent/detergent treatment of human plasma and other plasma-derived products and pasteurization of human serum albumin.Transfusion. 2017;57(3pt2):802-810.

11. Bichuetti-Silva DC, et al. Immediate infusion-related adverse reactions to intravenous immunoglobulin in a prospective cohort of 1765 infusions.Int Immunopharmacol. 2014;23(2):442–446.

This is an international website for octagam® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

IMPORTANT: The information on this website is based on the European Summary of Product Characteristics (EU SmPC).

If you wish to contact Octapharma please use the contact form on our corporate website.