Stepwise options for preparing therapeutic plasma proteins from domestic plasma in low- and middle-income countries

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

Stepwise access to safe plasma proteins in resource‐constrained countries:Local production and pathways to fractionation—Report of an International Society of Blood Transfusion Workshop

Background and Objectives Actions are needed to improve access to safe plasma-derived medicinal products (PDMPs) in low- and middle-income countries (LMICs). Materials and Methods The International Society of Blood Transfusion (ISBT) Working Party for Global Blood Safety organized an on-line workshop during 21–23 September 2021 to advance access to safe plasma proteins in resource-constrained countries, consistent with recent World Health Organization (WHO) guidance documents. Results The meeting drew attention to the considerable unmet needs for access to essential PDMPs in LMICs, in particular coagulation factors and immunoglobulins, and stepwise actions to address these deficits. First, improved access to safe plasma protein therapies requires blood component separation with prevention of wastage of recovered plasma. Quality and safety of collected blood and plasma must be assured so that plasma in excess of transfusion needs can be processed into safe plasma proteins. Second, local production of safe plasma proteins can be implemented using available technologies to locally obtain pathogen-reduced plasma and prepare pathogen-reduced cryoprecipitate and immunoglobulins from small plasma pools. Third, when a sufficient, stable volume of quality-assured plasma is available (approximately 50,000 L/year), contract or toll fractionation by a foreign plasma fractionator can expand the supply of PDMPs. Fourth, when the national infrastructure supports high-technology industrial production and stable volumes of quality plasma reach at least 200,000 L/year, technology transfer for domestic fractionation can be considered. Conclusion Action is needed including commitments of the organizations that made the workshop possible (WHO, ISBT, World Federation of Haemophilia [WFH], Plasma Protein Therapeutics Association [PPTA], International Plasma Fractionation Association [IPFA], International Patient Organization of Primary Immunodeficiencies [IPOPI] and International Federation of Blood Donor Organizations [FIODS])

International forum. an investigation of iron status in blood donors

No abstract availabl

Inclusion of cryoprecipitate, pathogen-reduced, in the who model lists of essential medicines for adults and children:a call for action

This is a commentary on the recent listing of cryoprecipitate pathogen-reduced on the WHO Model List of Essential Medicine

Inclusion of cryoprecipitate, pathogen-reduced, in the who model lists of essential medicines for adults and children:a call for action

This is a commentary on the recent listing of cryoprecipitate pathogen-reduced on the WHO Model List of Essential Medicine

Inclusion of cryoprecipitate, pathogen-reduced, in the who model lists of essential medicines for adults and children:a call for action

This is a commentary on the recent listing of cryoprecipitate pathogen-reduced on the WHO Model List of Essential Medicine

Inclusion of cryoprecipitate, pathogen-reduced, in the who model lists of essential medicines for adults and children:a call for action

This is a commentary on the recent listing of cryoprecipitate pathogen-reduced on the WHO Model List of Essential Medicine

Inclusion of cryoprecipitate, pathogen-reduced, in the who model lists of essential medicines for adults and children:a call for action

This is a commentary on the recent listing of cryoprecipitate pathogen-reduced on the WHO Model List of Essential Medicine

The evolving role of information technology in haemovigilance systems

This work provides an overview and appraisal of the general evolution of IS/IT in haemovigilance, from which lessons can be learned for its future strategic management. An electronic survey was conducted among the members of the International Haemovigilance Network to compile information on the mechanisms implemented to gather, process, validate, and store these data, to monitor haemovigilance activity, and to produce analytical reports. Survey responses were analysed by means of descriptive statistics, and comments/observations were considered in the final discussion. The answers received from 23 haemovigilance organizations show a direct relationship between the number of collected notifications (i.e., communication of adverse effects and events) and the technical specifications of the haemovigilance system in use. Notably, IT is used in the notification reception of 17 of these systems, out of which 8 systems are exclusively based on Web solutions. Most assessments of the evolution of IS/IT tend to focus on the scalability and flexibility of data gathering and reporting, considering the ever-changing requirements of haemovigilance. Data validation is poorly implemented, and data reporting has not reached its full potential. Web-based solutions are seen as the most intuitive and flexible for a system-user interaction.This work would not be possible without the precious collaboration of the IHN and the generous participation of the survey respondents. The SING group thanks CITI (Centro de Investigación, Transferencia e Innovación) from UniversityofVigoforhostingitsITinfrastructure.Thiswork was partially funded by the European Union’s Seventh Framework Programme FP7/REGPOT-2012-2013.1 (Grant Agreement no. 316265, BIOCAPS), the Fundação para a Ciência eaTecnologia (FCT) under thescopeofthestrategic funding of the UID/BIO/04469/2013 unit, and COMPETE 2020 (POCI-01-0145-FEDER-006684).info:eu-repo/semantics/publishedVersio