Immunoglobulin Supply and Safety

It is important that primary immunodeficiencies are recognised as a public health issue so that there is greater awareness of the causes of the presenting symptoms and thereby diagnosis of the underlying conditions rather than the simple treatment of the symptoms themselves. Precocious treatment (there is no prevention of the disease up to now!! ) of primary immunodeficiencies  will – in the long run – save huge costs for the society.

Several therapies are available for the treatment of primary immunodeficiencies. The vast majority of diagnosed conditions are treatable with blood products – especially immunoglobulins or C1-INH. It should be noted that those therapies neither cure the conditions nor do they reverse all the damage brought about by late diagnosis.

The blood product market place has been fraught with problems in the past. For example transmission of hepatitis C in some batches of immunglobulin ans HIV in blood products for haemophiliacs – but there has been no recent history of such problems due to the exhaustive viral control measures implemented during the manufacturing process of plasma derivatives.

The efficient removal of prions (responsible for vCJD) during the manufacturing processes of plasma derivatives has been well documented and measures have been taken to avoid using plasma from donors in areas of high risk.

This elimination of pathogens in immunglobulins is based on three principles:

1. Fractionation,
2. Inactivation, and
3. Elimination based on size (nanofiltration)

The market is vulnerable, however, and the need to achieve a balanced supply of product to meet growing demand can lead to acute product shortages and at times this can be a risk for primary immunodeficient patients.

It has to be appreciated that the costs involved in meeting the high standards in plasma collection and manufacturing, to ensure safe end products, are high but in the interests of the public health. Standards are demanded by regulatory authorities as well as industry itself.

It is also salutary to note that the blood product industry is the only industry that relies on the human body for its source product – i.e. human plasma – as opposed to raw non-human chemical materials.