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The Asia‐Pacific Plasma Leaders' Network (APPLN) plays a crucial role in addressing the regional shortage of plasma‐derived medicinal products (PDMPs), particularly in low‐ and middle‐income countries (LMICs). It provides a platform for experts to share their expertise and drive multi‐stakeholder collaborations. While several PDMPs are acknowledged by the World Health Organization (WHO) as life‐saving therapeutics on the Model List of Essential Medicine for treating various chronic and acute life‐threatening diseases, there are still many inadequacies in the availability and affordability of PDMPs. These challenges arise from insufficient domestic supplies of plasma suitable for fractionation, as well as a lack of technical and financial capabilities to implement contract or domestic plasma fractionation programmes. At two separate dialogue forums organized by the APPLN in 2023, experts discussed the unmet needs of PDMPs for individuals living with haemophilia and immunodeficiencies in the region. They also highlighted the limited access to early diagnosis and patient‐centred care in several LMICs. To address these issues, there is an urgent need to increase the availability of high‐quality domestic plasma for fractionation. Adopting a stepwise approach to utilize unused recovered plasma and establishing contract fractionation programmes could be viable strategies to potentially enhance PDMP availability in LMICs. However, achieving this goal requires improving existing domestic infrastructures for blood collection, implementing adequate policy reforms and fostering competent local leadership. Ultimately, there is no 'one‐size‐fits‐all' strategy for securing safe plasma proteins for all patients in need. Collaborative efforts are essential for achieving progressive self‐sufficiency in PDMPs. [ABSTRACT FROM AUTHOR]

Plasma‐derived medicinal products (PDMPs) are recognized internationally as essential medicines required to treat various acute and chronic conditions including congenital deficiencies of plasma proteins in haemophilia and primary immune deficiency. Global provision of these medicines is dominated by a small number of commercial companies, influencing the price and availability of the products. Achieving a level of strategic independence from this dominance is now seen as a public health priority in many countries. During the Regional Congress of the International Society for Blood Transfusion (ISBT) in Cape Town, South Africa, in November 2023, around 50 delegates from 24 countries participated in a workshop (WS) organized jointly by the International Plasma and Fractionation Association (IPFA) and the ISBT Working Party on Global Blood Safety on pathways towards provision of PDMPs from domestic plasma independent of commercial purchase in the open market. The WS was structured around three themes, each addressed by a separate group:Quality/safety requirements for plasma for fractionation (PfF)Stepwise access for safe plasma proteinsApproaching contract fractionation A synthesis of conclusions from these groups included the following:The need to acquire support from government authorities for a national plasma policy, recognizing the difficulties posed by unstable political and bureaucratic environments.The value of embedding plasma and PDMPs within a patient blood management (PBM) paradigm to promote optimal clinical use of PDMPs.Training of blood/plasma collection personnel in the relevant principles of Good Manufacturing Practice (GMP), coupled with regulatory oversight of plasma product production in the engaged jurisdictions.Appreciation that limited access to contract fractionation may necessitate a stepwise approach, which may include small‐scale preparation of versions of essential plasma proteins as an intermediate phase towards the manufacture of industrial‐scale PDMPs from domestic plasma. [ABSTRACT FROM AUTHOR]

Industrial plasma fractionation, a complex and highly regulated technology, remains largely inaccessible to many low‐ and middle‐income countries (LMICs). This, combined with the limited availability and high cost of plasma‐derived medicinal products (PDMPs), creates deficiency of access to adequate treatment for patients in resource‐limited countries, and leads to their suffering. Meanwhile, an increasing number of LMICs produce surplus plasma, as a by‐product of red blood cell preparation from whole blood, that is discarded because of the lack of suitability for fractionation. This article reviews pragmatic technological options for processing plasma collected from LMICs into therapies and supports a realistic stepwise approach aligned with recent World Health Organization guidance and initiatives launched by the Working Party for Global Blood Safety of the International Society of Blood Transfusion. When industrial options based on contract or toll plasma fractionation programme and, even more, domestic fractionation facilities require larger volumes of quality plasma than is produced, alternative methods should be considered. In‐bag minipool or small‐scale production procedures implementable in blood establishments or national service centres are the only realistic options available to gradually reduce plasma wastage, provide safer treatments for patients currently treated with non‐pathogen‐reduced blood products and concurrently improve Good Manufacturing Practice (GMP) levels with minimum capital investment. As a next step, when the available volume of quality‐assured plasma reaches the necessary thresholds, LMICs could consider engaging with an established fractionator in a fractionation agreement or a contract in support of a domestic fractionation facility to improve the domestic PDMP supply and patients' treatment. [ABSTRACT FROM AUTHOR]

The article responds to comments from the International Patient Organization for Primary Immunodeficiencies (IPOPI) regarding the preparation of therapeutic plasma proteins in low- and middle-income countries (LMICs). The authors disagree with IPOPI's view that local, small-scale preparation of immune globulins should not be part of the approach, arguing that single-step virally inactivated products prepared from plasma mini-pools are reasonably safe and effective. They acknowledge the need for further study of immunoglobulin G (IgG) preparations in patients with primary immunodeficiency (PID) and emphasize the importance of viral safety and manufacturing validation. The authors believe that the stepwise approach, including local, small-pool preparation, is a pragmatic pathway for LMICs to improve access to plasma protein therapies while working towards availability and affordability of plasma-derived medicinal products (PDMPs). [Extracted from the article]

Plasma-derived protein therapeutics include coagulation factors and immunoglobulins, which are on the WHO Model List of Essential Medicines [1]. If qualified, this currently wasted plasma could be used to manufacture safe and effective products to save or improve the quality of life of patients with haemophilia, primary immune deficiency, and many other congenital or acquired diseases associated with a treatable plasma protein deficiency [4]. [Extracted from the article]

Presents an overview of hemovigilance initiatives around the world, designed to reduce errors in blood transfusion. Establishment of a centralized national reporting system for adverse reactions to transfusion in Australia; Involvement of the Red Cross in the development of reporting systems in Japan, Thailand, the United States and other countries.

Prostate cancer is one of the most common cancers among men and has long been recognized to occur in familial clusters. Identification of genetic susceptibility loci for prostate cancer has however been extremely difficult, and only in 1996 was the first prostate cancer susceptibility locus HPC1 mapped to chromosome 1q24-25. Since, several additional putative loci have been identified by genetic linkage analysis on chromosome 1, 17, 20 and X (reviewed in). For three of these loci, family-based studies have identified three genes associated with inherited prostate cancer: the 3' processing endoribonuclease ELAC2/HPC2 gene, the macrophage scavenger receptor 1 gene (MSR1), and the endoribonuclease RNase L gene (RNAse L/HPC1). Here we will focus our review on the RNAse L gene and its involvement in prostate cancer and other diseases.