Octapharma News August 13th, 2004

August 13th, 2004

IVIG: How Safe is Your Product?

Wednesday 23rd July, Montreal, Canada
Over 100 clinical immunologists from more than 10 countries attended Octapharma's satellite symposium during the recent FOCIS meeting in Montreal, where leading European virologist Professor Tino F Schwarz addressed the thought provoking topic,
IVIG: How Safe is Your Product?

Rejecting the commonly held belief that all IVIG products are equal in terms of safety, efficacy and tolerability, Professor Schwarz eloquently discussed the risks of pathogen transmission, the different viral safety requirements of the US and European regulatory authorities as well as the safety differences between the various different commercial preparations.

In his review of the various virus inactivation / removal procedures used by plasma fractionators, Prof. Schwarz urged the audience to be critical when interpreting the data provided to them by the manufacturer. Total log reductions can be misleading, he cautioned, and unless they can be reviewed alongside the inactivation kinetics, it is not possible to assess the rapidity or robustness of the inactivation step or the consequent safety margin of the product.


Prof. Dr Tino F Schwarz

Prof. Schwarz MD, Head of the Virology Laboratory at Foundation Juliusspital, Würzburg; Germany, went on to explain that the virucidal steps used by manufacturers have the potential to negatively affect the efficacy and /or tolerability of the IVIG preparation.
Some methods may damage the Fc portion of the IgG molecule, limiting effectiveness of products thus treated, particularly in the treatment of bacterial infection and immune modulation; whereas solvent detergent, whilst providing extremely rapid inactivationof enveloped viruses has virtually no effect on plasma proteins such as IgG.

Prof. Schwarz also stressed the importance of understanding the mode of action of the chosen pathogen inactivation method in order to be able to predict its effectiveness against newly emerging or so-called "unknown" viruses. To further ensure safety, all plasma products should incorporate at least two separate and distrinct inactivation / removal steps in their manufacture, as mandated by the European and German regulatory authorities. He then cited Octagam as product that fulfills the strictest of the viral safety guidelines and provided examples of its extensive virus and pathogen validation data.


Dr Adina Knight receives her prize from Octapharma's Michelle Dolan

Following the symposium, attendess answered a series of questions based upon the lecture. Correct answers were entered into a prize draw. The lucky and skillful winner was Dr Adina Knight an Immunology Fellow from Mt. Sinai Hospital, New York.

Please click here for a pdf copy of Prof Schwarz lecture.

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