Supplementary quality controls of plasma fractions for manufactures and consumers

As a consequence of the increasing use of plasma fractions, there is an ever-growing abundance of such preparations. These preparations may be divided into three main groups: clotting factors, immunoglobulins, and plasma protein solutions. Frequency of component-induced side-effects are inversely proportional to those components' quality. Pharmacopoeas presently require only the following quality criteria for most plasma preparations: declaration of sort and concentration of the active component and stabilizers, sterility, and the absence of pyrogens. Of great importance is the origin of the raw material and the methods used to harvest the plasma, as well as the molecular condition of the proteins. While we can assume that presently-available preparations meet minimum requirements, it can be demonstrated that similar preparations can in no case be considered equivalent when immunoelectrophoresis, ultracentrifugation and gel filtration are used as additional quality control tests. Especially immunoelectrophoresis and gel filtration are tests easily available to the clinician to help him detect and thus select the optical product.