Blood, tissue and cell establishments (BTCs) stand out in the management of donor selection, procurement and processing of all types of substances of human origin (SoHO). In the last decades, the framework created around BTCs, including hospitals and national health system networks, and their links to research, development and innovation organizations and agencies have spurred their involvement in the study of groundbreaking advanced therapy medicinal products (ATMP). To further improve strategic synergies in the development of ATMPs, it will be required to promote intra- and inter-European collaborations by creating an international network involving BTCs and major stakeholders (i.e., research organizations, hospitals, universities, patient associations, public agencies). This vision is already shared with the European Blood Alliance, the association of non-profit blood establishments, with 26 member states throughout the European Union and European Free Trade Association states. Herein we present and analyze the "BTC for ATMP Development And Manufacture" (BADAM) model, an ethically responsible business model based on the values and missions of BTCs and their commitment to health equity, patient access and education (based on voluntary donation of SoHO to address unmet clinical needs, while contributing to training professionals and scientific literacy of our Society).

In the United States and other high-income countries, blood donation primarily relies on anonymous, voluntary donors. However, directed blood donation-where people donate for a specific recipient-has resurged, particularly due to misinformation surrounding COVID-19 vaccination. Requests for "nonvaccinated" blood, driven by misconceptions about vaccine safety, have led to legislative attempts to mandate compliance. Historically, directed donation was used to mitigate the risk for transfusion-related infections before modern screening techniques rendered it largely unnecessary. Today, it presents important patient safety risks, including increased infectious disease transmission, immunologic complications, and logistic burdens. Directed donations also introduce inefficiencies, diverting resources from the community blood supply and exacerbating shortages. Moreover, directed donation for nonmedical indications lacks scientific justification. Blood safety is ensured through rigorous donor screening, pathogen testing, and processing measures. There is no evidence that blood from vaccinated donors poses risk. Requests for nonvaccinated blood, as well as other directed donation preferences based on personal beliefs, introduce biases that are not grounded in medical necessity. Accommodating such requests undermines public trust in blood safety protocols and legitimizes unfounded fears. Ethical concerns arise as non-medically justified requests reinforce discriminatory practices, such as selecting donors based on race or gender. Allowing such preferences risks politicizing blood donation, spreading misinformation, and straining health care systems. Although autonomy is a core ethical principle in medicine, it does not justify non-evidence-based interventions. Given the potential harm and societal impact, directed blood donations should be limited to rare, medically necessary cases. Ongoing legislative efforts to mandate these requests require unified opposition from the medical and scientific community to uphold ethical, evidence-based, blood allocation practices.

Background and Objectives: Room temperature‐stored platelets (RTPs) maximize platelet viability but limit shelf life. The aims of this study were to investigate the impact of donor variability on cold‐stored platelets (CSPs) and RTP, to determine whether RTP quality markers are appropriate for CSP.Materials and Methods: Double platelet donations (n = 10) were collected from consented regular male donors stored in 100% plasma. A full blood count, donor age, weight, height and body mass index (BMI) were collected at the time of donation. Platelet donations were split equally into two bags, and assigned to non‐agitated CSP or agitated RTP. The quality and function of platelets were assessed throughout the standard 7 days of storage and at expiry (day 8). Non‐parametric statistical analyses were used to analyse results given the small sample size.Results: As expected, there were significant differences between CSP and RTP throughout storage including a reduction in CSP concentration as well as a loss of swirling. Furthermore, a significant increase in CSP exhibiting activation and apoptotic markers was observed. Platelet concentrations were further impacted by donor BMI, and donors with the highest BMI (>29) had the lowest platelet concentration and activation response at the end of CSP storage.Conclusion: Platelet quality and functionality play a vital role in transfusion outcomes; however, blood components are inherently variable. This study demonstrated, for the first time, the specific impact of donor BMI on CSP quality and function and highlights the requirement for novel quality markers for assessing CSPs.