The Future of Plasma Derivatives

Abstract

This two-day meeting was organised by Life Sciences Division of IBC Global Conferences Limited. It was attended by an international, multidisciplinary group of experts with differing expertise and perspectives on the provision of therapeutic products derived from human plasma. The delegates ranged from those involved with the collection of plasma donations, the scientists dedicated to improving the screening tests for virus markers, quality assurance personnel, clinicians, marketing and business managers, members of regulatory agencies in Europe and the Food and Drug Administration (FDA), providers of services to the industry and last, but not least, patient groups were represented. Fifteen to twenty countries were represented by the delegates and speakers. Although it might seem that the background and expertise of the audience was so wide that the lectures would have to be superficial, this was not the case. The whole process from plasma (or blood) collection to injection of a product into a patient was already well-known to senior members of the various organisations present and there is a tremendous amount of inter-dependence which enhances the necessary level of understanding. Nevertheless, the speakers were able to expand the knowledge of the delegates by their lucid and detailed presentations. The issues associated with development and implementation of new technologies, such as new NAT tests and different virus inactivation processes, were fully described. The spotlight also fell on the effects that changing patterns of demand for individual therapeutic proteins are having and will continue to have on the economics of the industry and on patient groups. Unlike other manufactured products, the raw material is the same for all plasma-derived products. Demand for all these products is limited by the availability of the donated plasma. Ideal demand for economic reasons is a balance of the extractable proteins in the donation. The implementation of European regulations was reviewed from the industry and from the regulators. Flexibility shown by the FDA in responding to the shortages of iv. immunoglobulins (Ig) was described, particularly with regard to clinical evaluation. Finally, the rationale for the need to revise the CPMP guidelines for clinical evaluation of certain plasma products was described as were the difficulties to be expected with implementation.

• albumin
• clinical trials
• coagulation factors
• harmonisation
• immunoglobulin
• PCR