Octapharma News November 16th, 2004

November 16th, 2004

WFH Joint Symposium Review – Natural Proteins in the Treatment of Blood Disorders: Return to Reason

Dr Bernard Horowitz (Key Biscayne, USA. Plasma-Derived and Recombinant AHF: Pathogen Safety by Design), co-inventor of the solvent-detergent method of virus inactivation, emphasised the numerous measures introduced by the plasma industry and the regulatory authorities to ensure product safety in the last two decades. Among others, these range from the concept of qualified donors and the increasingly sensitive NAT tests for viral pathogens, for source material, to double, or even multiple, virus inactivation and/or removal techniques in the manufacture of blood products, as well as plant and process validations.

Calculations made in the 1990s about potential viral load in coagulation products were examined in today’s light. The safety of modern pdFVIII concentrates ranges from more than 1 million patient-years for hepatitis A virus to more than 10¹¹ patient-years for any enveloped virus. Parvovirus B19 transmission has not been observed for doubly viral inactivated pdFVIII concentrates made from NAT tested plasma. The very low titre of infectious prion protein, if present at all in plasma, coupled with validated purification steps continues to render the transmission of prion disease hypothetical. These predictions have been borne out by years of incident-free clinical experience, both for pdFVIII and rFVIII preparations which, owing to their method of manufacture, must also demonstrate adequate pathogen clearance.

Dr Horowitz concluded that selection of a product should not depend on pathogen safety because both pdFVIII and rFVIII are safe today. This essentially mirrors the standpoint of the regulatory authorities.

In the discussion, Dr Horowitz pointed out that the efficacy and robustness of the measures introduced for the safety of pd preparations have already been successfully put to the test in the face of two, recent, novel virus infections, West Nile Virus and SARS Virus.

© Octapharma AG, 2004