Supplementary quality controls of plasma fractions for manufactures and consumers
Schneider, W.
Folia Haematologica 107(2): 291-298
1980
ISSN/ISBN: 0323-4347 PMID: 6159270 Document Number: 162019
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 3 main groups: clotting factors, Ig and plasma protein solutions. Frequency of component-induced side-effects are inversely proportional to those components' quality. Pharmacopeia 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 and the molecular condition of the proteins. Immunoelectrophoresis, ultracentrifugation and gel filtration are used as additional quality control tests. Immunoelectrophoresis and gel filtration are tests easily available to the clinician for detecting and selecting the best product.