Current status and new developments in the production of plasma derivatives

Abstract

Plasma fractionation is a unique biotechnology and bioengineering industry characterized by its capacity to extract a diverse range of protein therapeutics that are often the only options for treating life‐threatening pathological conditions of patients suffering from bleeding, immunological disorders, infections or trauma. Current plasma products include several coagulation factors, polyvalent and hyperimmune immunoglobulins (Igs), albumin, protease inhibitors and anticoagulants. In many pathological situations, these products are used for long‐term replacement therapy to compensate for a congenital or acquired protein deficiency. Most products are obtained by plasma fractionation technologies that derive from the cold ethanol fractionation process developed in the mid‐/late 1940s by Cohn and collaborators. Still, in the last 20 years, this core technology has undergone substantial evolutions illustrated by the integration of several viral reduction steps for all products and by the introduction of chromatographic purification steps to extract labile proteins from cryoprecipitate‐poor plasma. The most recent technological changes, intended mostly to improve recoveries and remove trace protein contaminants, concern the production process of intravenous Igs through implementing chromatographic steps and caprylic acid treatment in early stages of the ethanol fractionation process. A number of new fractionation technologies are currently under development and have not been licensed at least for the time being by major regulatory authorities. One target of these technologies is to improve the recovery of the most important plasma protein products, under conditions facilitating large‐scale implementation in emerging countries.

Blood and Blood Components: From Similarities to Differences

“…Consistent efforts have been made by large bodies such as EDQM, the American Blood Bank Association or the International Society for Blood Transfusion ISBT to define safety and quality parameters that should apply to each issued LBC; however, this is still a range above and beyond which the LBC should not conform to standards; if testing is individual for most infectious markers (and even some are tested in pools), hematological markers are frequently tested by sampling to define quality ( 4 ). This is the reason why we call attention here on the false homogeneity of LBCs despite they go by the noun of “standard.” This is in sharp contrast to the actual standardization of plasma derivatives obtained from 100 of 1000s of collections and subjected to an industrial processing ( 47 ).…”

Optimizing Blood Transfusion Service Delivery across the West African Sub-Region

“…Fractionation of plasma can generate a range of purified, virally inactivated, protein therapeutics that can potentially reduce some adverse effects (fevers, chills, transfusion-transmitted infections like CMV, HTLV-1 and 2 as well as prevent volume overload) while providing a better treatment for people suffering from haemophilia or immunodeficiency and other diseases that requires plasma derived proteins for the management. The plasma derived from blood component can be fractionated to produce various Plasma-derived Medicinal Products (PDMPs) of significant economic and therapeutic value [32,33]. The effective implementation of BCT across the West African Thalassemia Syndromes -New Insights and Transfusion Modalities region is a huge but surmountable technological challenge hindered in many cases by the lack of a fit for purpose and structured national blood transfusion service, suboptimal number of qualified and skilled health workers, uninterrupted power supply challenges and challenge associated with cold-chain management of blood components.…”