Why do US source plasma donors stop donating?

See article on page 2941–2957, in this issue

Plasma-derived medicinal products (PDMPs) are pharmaceuticals prepared using proteins in plasma, a liquid component of blood. Regarding the use of human blood as a raw material in PDMP manufacturing, it has unique characteristics unlike other pharmaceuticals (for example, limitations of scientific identification, finiteness of blood, and risk of infection through disease pathogens, such as the human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in the blood). The safety management policy of PDMPs in Korea started with the enactment of the Blood Management Act in 1970. After that, the current safety management system was established through product approval management according to the Pharmaceutical Affairs Act in 2006, higher standards of safety management for imported source plasma in 2009, and expansion of management standards for source plasma in 2012. The safety management of PDMPs involves several important policies. Public management has been carried out by the Korean Red Cross and national government, and domestic plasma should be used first, while imported plasma may be used only if there is not enough. Additionally, to ensure blood products safety, plasma testing, inventory hold, and plasma master file reporting obligations are being implemented. In addition, it is managed as a subject of national lot release, which should also be quality-confirmed by the country. Because the supply of domestic source plasma, which is the raw material of PDMPs, has shown a decreasing trend in recent years, continuous monitoring and preparation is required. In this study, we describe the history of safety management policies, including the definition and classification of PDMPs, product status, usage status of source plasma, and the related policy guidelines and characteristics.

Background and Objective: In order to meet the safety challenges arising from the contamination events of the 1970s and 1980s, a multi-layer safety approach was established to reduce and prevent the risk of pathogen transmission via plasma-derived medicinal products (PDMPs). This safety framework, often referred to as the safety tripod, integrates three complementary pillars: donor screening, testing, and pathogen reduction during manufacturing. Over the years, each pillar has evolved in light of changing scientific knowledge. Donor selection and increasingly sensitive testing methods have reduced the risk of potentially contaminated plasma entering the manufacture pools, while the use of validated pathogen reduction steps during manufacturing provide protection against both the known and emerging pathogens. Considering the challenges posed by the recent outbreaks, a review of safety strategies used for various PDMPs and the latest evidence on the effectiveness of safety strategies is needed for future considerations. The objective of this review was to provide an overview of the historical development and current state of the safety measures used in PDMP manufacturing. Methods: A literature search was conducted using PubMed and Google Scholar for English-language publications from 1990 to September 2025. For the construction of the historical timeline of events, publications were initially identified by author T.S. through his professional expertise in the PDMP industry and were further supplemented with a separate search of literature from 1940 to 1995. Key Content and Findings: In light of the continued evolution of each pillar, pharmacovigilance data and published literature point towards continued safety of PDMPs against known and emerging pathogens. Conclusions: While the theoretical risk of infection remains, continuous surveillance of emerging pathogens, innovation, and periodic evaluation of each element of the safety tripod based on new scientific evidence remain essential in maintaining and advancing PDMP safety.

In recent years, the national usage of Plasma Derived Medicinal Products (PDMPs), particularly albumin and immunoglobulin, has expanded due to a rise in disease prevalence, as well as enhanced patient management practices and broader assurance coverage. Now, Indonesia is a country that imports all of its PDMPs, resulting in high pricing and market reliance; nevertheless, barely a third of recovered plasma gets transfused to patients. The plasma that has not been used should be discarded, at a cost. The government intended to begin meeting the needs of the PDMP by implementing the plasma fractionation program. The decision was taken to use contract fractionation for three years, after which a national fractionation manufacturer was anticipated. The potential utility of recovered plasma and the prospective requirement for plasmapheresis collection have been assessed. The Minister of Health has enacted legislation concerning plasma fractionation, including the potential of establishing plasmapheresis centers to facilitate plasma collections. The Food and Drug Administration of Indonesia has also initiated a certification scheme for blood establishments (BEs), and only certified BEs can provide plasma for fractionation. After the epidemic, the government restarted the fractionation program by modifying existing laws to allow private manufacturers to participate. The difficulty was obtaining plasma from uncompensated donors, recruiting plasma donors, increasing the number of qualified biological examiners, of which only 19 out of 469 have been certified, and increasing technology and personnel capacities. Other significant obstacles were the harmonization or consolidation of existing biological entities (BEs) and the expense of paying for recovered and source plasma. The government and other parties involved had to make substantial efforts and collaborate to overcome these problems.

Insights into voluntary plasma donation: A study of motivators and obstacles.

Therapeutic Plasma Exchange: Core Curriculum 2008

Plasma-derived products and Creutzfeldt-Jakob disease: Comparison of legislation around the world

Trends in Plasma Exchange Use in Optic Neuritis Hospitalizations in the United States

Plasma exchange and COVID 19

BackgroundHuman parvovirus B19 (B19V) is a frequent contaminant of blood and plasma-derived medicinal products. To ensure the quality and safety of plasma-derived products, European regulations, Plasma Protein Therapeutics Association (PPTA) standard and FDA guidelines require testing of manufacturing plasma for parvovirus B19 DNA to limit the load of this virus. In China, however, there have been no related documentation and technical guiding principles for monitoring B19V, moreover, an adequate level of information on the prevalence of B19V in Chinese plasma donations is not available.FindingsBy using an in-house quantitative polymerase chain reaction (qPCR) assay adapted for all three genotypes of B19V, 235 source plasma pools from three regional different Chinese manufacturers of blood products were screened and quantified. Results showed that 71.91 % (169/235) of plasma pools were contaminated by B19V, with the concentrations of 5.18 × 102–1.05 × 109 IU/mL. Approximately 31.95 % of the DNA-positive plasma pools were only moderately contaminated (<104 IU/mL), while 68.05 % contained >104 IU/mL.ConclusionsThe high level of B19V in plasma pools could present a great risk in plasma derivatives. Therefore, the implementation of B19V NAT (Nucleic Acid Testing) assays capable of detecting all B19V genotypes and discard donations with high titer B19V DNA for Chinese blood products manufacturers seems to be necessary.

Plasma-derived medicinal products (PDMPs) are essential medicines required for the treatment of congenital, rare, and acquired diseases. At present, the market dynamics of these products have led to high dependence on a few producing countries, causing shortages, stockouts, and problems related to access in general. To help solve this problem, this document proposes a value model for PDMPs from a public health perspective, and considers the prospects, visions, and challenges to implementation in Colombia, as a case study. These proposals seek to contribute to the development of strategic independence in plasma, while promoting equitable access to PDMPs in the Region of the Americas. They are the result of a series of discussions and semi-structured interviews with national and international stakeholders from different public and private sectors, and with leaders of the National University of Colombia and the International Plasma and Fractionation Association (IPFA). It is hoped that these proposals will serve as an example for other countries in the Region to include this issue in their public policy agenda.

Plasma-derived medicinal products (PDMPs) are life-saving and life-improving therapies, but the raw material is in short supply: Europe depends on importation from countries including the United States. Plasma from donors resident in the United Kingdom has not been fractionated since 1999 when a precautionary measure was introduced in response to the outbreak of variant Creutzfeldt-Jakob disease (vCJD). Cases of vCJD have been far fewer than originally predicted in the 1990s. Since the introduction of leucodepletion in 1999, and accounting for the incubation period, more than 40 million UK-derived blood components have been issued with no reports of TT vCJD. In February 2021, the UK Government authorized manufacture of immunoglobulin from UK plasma. Following separate reviews concluding no significant difference in the risk posed, the United States, Australia, Ireland and Hong Kong also lifted their deferrals of blood donors with a history of living in the United Kingdom. Other countries are actively reviewing their position. Demand is rising for PDMPs, and Europe faces a threat of supply shortages. Industry and patient groups are clear that using UK plasma would bring significant immediate benefits to patients and to the resilience of the European supply chain. From this scientific review, we conclude that UK plasma is safe for fractionation and urge blood regulators and operators to take account of this safety profile when considering fractionation of UK plasma, and to revise their guidelines on the deferral of donors who have lived in, or received a transfusion in, the United Kingdom.

A donor health questionnaire (DHQ) aims to ensure the safety of donors and recipients of transfusions or transplantations with blood components, plasma-derived medicinal products, tissues, haematopoietic stem cells and medically assisted reproduction (in short substances of human origin; SoHO). Currently, many different DHQs exist across countries and SoHO. TRANSPOSE (TRANSfusion and transplantation PrOtection and SElection of donors) developed and validated a standardized DHQ to use across countries and SoHO. We tested whether participants understand the questions and provide honest answers. For the validation of the standardized DHQ, two demographically representative online surveys were conducted in Germany (N=3329) and Austria (N=3432). We surveyed whether participants understood each DHQ question and would answer the questions truthfully. We used experimental settings to test whether there is a difference between mode of administration (print vs. online), the order of the questions (subject vs. chronological order), and the positioning of the general state of health question (beginning vs. end) in the DHQ. Using regression models, we tested the DHQ's impact on participant mood after completion and on socially desirable response behaviour. Participants understood the DHQ questions well and would answer them honestly. Nevertheless, the data show different levels of understanding and honesty when responding. Administration mode was the only characteristic that had a significant influence on mood, with the online version resulting in a more favourable mood in comparison to the printed version. The DHQ was well understood and had a low dishonest tendency. Our findings can serve as an impulse for further research on DHQ criteria across other SoHO and countries.

Encouraging existing plasma donors to donate more frequently is a key objective for blood donation services committed to expanding yield through voluntary non-remunerated plasmapheresis donation. This requires an understanding of donors' perspectives on their current donation practice and how this relates to their knowledge and beliefs about the need for plasma. To explore this, Australian plasma donors were interviewed about how they arrived at the frequency at which they donate. Semi-structured telephone interviews were conducted with 105 Australian plasmapheresis donors. Key themes identified were as follows: fitting donation into busy lives and how ideas about being an ongoing donor and the institutional context shaped their perspective on frequency; perceptions of the impact of donation on health; and wanting to make a greater contribution. Experienced plasma donors work to maintain a donation practice in the context of busy lives often by adopting a flexible approach to donation frequency. Their knowledge of the contribution their donations make is key to their continued donation, yet most identified constraints to donating more frequently. Health concerns were a particular concern for some, and more research is needed to understand donors' perspectives on the impact of donating on their health.

Plasma Exchange for ANCA-Associated Vasculitis: An International Survey of Patient Preferences