How do I facilitate a rapid response to a public health emergency requiring plasma collection with a public-private partnership?

In March 2020, there were no treatment options for COVID-19. Passive immune therapy including anti-SARS-CoV-2 hyperimmune globulin (hIVIG) was a logical candidate for COVID-19 therapeutic trials, given past success treating emerging pathogens with endogenous neutralizing antibodies. We established a plasma collection protocol for persons recovered from COVID-19. To speed recruitment in the first U.S. hotspot, Seattle, Washington, federal and state public health agencies collaborated with Bloodworks Northwest to collect convalescent plasma (CP) for manufacturing hIVIG. During March-December 2020, we identified and recruited prospective CP donors via letters to persons recovered from COVID-19 with laboratory-confirmed SARS-CoV-2 infection. Prospective donors were pre-screened and administered a medical history survey. Anti-SARS-CoV-2 neutralizing antibody (NAb) titers were classified as qualifying (≥1:80) or non-qualifying (<1:80) for enrollment based on a live virus neutralization assay. Generalized estimating equations were used to identify characteristics of donors associated with qualifying versus nonqualifying NAb titers. Overall, 21,359 letters resulted in 3207 inquiries, 2159 prescreenings with laboratory-confirmed SARS-CoV-2 infection, and 573 donors (27% of all pre-screenings with confirmed infection) who provided a screening plasma donation. Of 573 donors screened, 254 (44%) provided plasma with qualifying NAb titers, resulting in 1284 units for hIVIG manufacture. In a multivariable model, after adjusting for other factors, time (60 days) from COVID-19 symptom onset to screening was associated with lower odds of qualifying NAb (adjusted odds ratio = 0.67, 95% CI: 0.48-0.94). The collaboration facilitated a rapid response to develop and provide hIVIG for clinical trials and CP for transfusion. Only 1 in 12 donor inquiries resulted in a qualifying plasma donation. Challenges included recruitment and the relatively low percentage of persons with high NAb titers and limited screening capacity. This resource-intensive collaboration may not be scalable but informs preparedness and response strategies for plasma collection in future epidemics. Operational readiness plans with templates for screening, consent, and data collection forms are recommended.

Effect of high nucleated cell concentration on product viability and hematopoietic recovery in autologous transplantation.

BACKGROUND: Administering lower total product volumes with high nucleated cell (NC) concentrations may have the potential benefit of decreasing volume- and dimethyl sulfoxide (DMSO)-related patient complications, while maximizing the laboratory's freezer storage capacity. Our study is a retrospective investigation of the effect of HPC(A) products with cell concentrations greater than 3 × 108 NC/mL on clinical and product outcomes in patients undergoing autologous peripheral blood stem cell (PBSC) transplantation. STUDY DESIGN AND METHODS: A total of 113 consecutive patients with hematological malignancies who underwent autologous PBSC transplantation were included in this retrospective analysis. The primary outcomes were days to initial absolute neutrophil count (ANC) recovery and initial platelet recovery. The secondary outcomes included the storage duration, segment thaw viability, and dose of viable CD34+ cells/kg administered. RESULTS: Of 92 patients and 176 apheresis procedures, 81 patients received HPC(A) products with high NC concentration (4.1 × 108 NC/mL), and 11 patients received low NC concentration products (2.4 × 108 NC/mL). There were no observed differences in clinical outcomes with respect to ANC recovery (14 vs. 14 vs. 12 days) and platelet recovery (16 vs. 16 vs. 15 days) when very high NC (5.2 × 108 NC/mL) and high NC (4.1 × 108 NC/mL) groups were compared to the low NC group (2.4 × 108 NC/mL). CONCLUSION: Our retrospective investigation provides further supporting evidence that HPC(A) products with cell concentration greater than 3 × 108 NC/mL did not show detrimental effects on the clinical outcomes in patients undergoing autologous PBSC transplantation.