Blood derivative therapy

There are three main components manufactured from whole blood: red blood cells (RBCs), plasma, and platelets. Plasma contains a multitude of different proteins, peptides, and biologic substances. Approximately 53 million liters of plasma was collected in the United States in 2019. Following collection, plasma is frozen and manufactured into plasma-derived medicinal products (PDMPs). During the manufacture process, several thousand plasma units are pooled for Cohn fractionation, which is based upon cold ethanol precipitation of proteins. The PDMPs are further prepared using ion exchange or affinity chromatography and additional steps to inactivate and remove infectious diseases such as viruses. Almost 20 different therapeutic plasma proteins are purified from plasma via these multi-step manufacturing processes. Interestingly, the demand for pharmaceutical plasma products, particularly intravenous immunoglobulin (IVIG) products, has been increasing. The manufacture and therapeutic role of blood derivatives particularly immunoglobulin therapy, Rh immunoglobulin (RhIG), COVID-19 convalescent plasma (CCP) and hyperimmune globulins, albumin, clotting factors, fibrin sealants, and platelet rich plasma will be described.Copyright © 2022 AME Publishing Company. All Rights Reserved.

Understanding the experiences of plasma donors in Canada's new source plasma collection centres during COVID-19: A qualitative study.

BACKGROUND AND OBJECTIVES: To address a national concern over the sufficiency of plasma, Canadian Blood Services (CBS) initiated a proof-of-concept programme with three new source plasma collection centres, aiming to demonstrate a cost-effective template for future source plasma collection and to alleviate the concerns and risks associated with the dependence on the United States. This study uses social capital as a framework to assess the success of the proof-of-concept collection centres. MATERIALS AND METHODS: One-hundred and one qualitative interviews with source plasma donors in three new source plasma centres in Canada were carried out. RESULTS: CBS played a critical role in motivating whole-blood donors to switch to plasma donation by building on their identity as a donor and facilitating access. Community was central to ensuring that donors returned. The importance of the social network was apparent through relationships participants developed with staff and through the relationships that staff had with each other. Donors wanted to understand more about the uses of plasma so that they could promote donation through their social networks outside the centre. CONCLUSION: Campaigns to convert existing blood donors to plasma donors should build on their identity as a donor and structure the centre as a safe and welcoming place. To retain donors, blood collection agencies should emphasize community by facilitating staff ability to work well together and connect with the donor. Blood operators have the potential to expand existing social networks and foster trust through the dissemination of knowledge about plasma more broadly in more diverse communities.

Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram.

BACKGROUND: Source plasma is essential to support the growing demand for plasma-derived medicinal products. Supply is short, with donor availability further limited by the coronavirus disease 2019 (COVID-19) pandemic. This study examined whether a novel, personalized, technology-based nomogram was noninferior with regard to significant hypotensive adverse events (AEs) in healthy donors. STUDY DESIGN AND METHODS: IMPACT (IMproving PlasmA CollecTion) was a prospective, multicenter, double-blinded, randomized, controlled trial carried out between January 6 and March 26, 2020, in three U.S plasma collection centers. Donors were randomly assigned to the current simplified 1992 nomogram (control) or a novel percent plasma nomogram (PPN) with personalized target volume calculation (experimental). Primary endpoint was the rate of significant hypotensive AEs. Noninferiority (NI) was tested with a margin of 0.15%. Collected plasma volume was a secondary endpoint. RESULTS: A total of 3443 donors (mean [SD] BMI: 32 [7.74] kg/m2 ; 65% male) underwent 23,137 donations (median [range]: 6 [1-22] per subject). Ten significant hypotensive AEs were observed (six control; four experimental), with model-based AE incidence rate estimates (95% CI) of 0.051% (0.020%-0.114%) and 0.035% (0.010%-0.094%), respectively (p = .58). NI was met at an upper limit of 0.043% versus the predefined margin of 0.15%. There was no statistical difference between total AEs (all AE types: p = .32). Mean plasma volume collected was 777.8 ml (control) versus 841.7 ml (experimental); an increase of 63.9 ml per donation (8.2%; p < .0001). CONCLUSION: This trial showed that a novel personalized nomogram approach in healthy donors allowed approximately 8% more plasma per donation to be collected without impairing donor safety.