ABSTRACT
Background: Hematopoietic stem cell preparations are pharmaceuticals that are typically transfused as fresh products. Due to the travel restrictions caused by the Covid-19 pandemic since March 2020, the supply of fresh stem cell preparations to patients became significantly challenging. To maintain global patient supply, a GMP-compliant manufacturing process for cryopreservation of allogeneic stem cell donations was established and validated. Method(s): The donor leukapheresis is transported from the collection center to the manufacturing site at 2-6degreeC using qualified containers. In class D clean rooms, this material is further processed in a completely closed process. If necessary, volume reduction is performed by centrifugation. The suspension is mixed with the cryoprotectant Cryostore CS10 to achieve a final DMSO concentration of 5%. The formulated product is filled into cryobags and cryopreserved under controlled freezing conditions. The frozen products are stored and transported at <= 140 degreeC. The cell counter NC-200 is used to determine the cell count and viability of the product. 97 products in 2020 and 127 products in 2021 were successfully cryopreserved and transported worldwide. Result(s): The mean values of viability of 215 products are 99.3 % (+/- 1.1 % SD) for fresh apheresis products and 93.1 % (+/- 6.2 % SD) for the corresponding cryopreserved final product after thawing. For a good recovery after thawing, the age of the apheresis as well as the DMSO contact time are generally considered to be critical factors. The analysis of the viability of 222 cryopreserved end products after thawing shows a correlation in relation to the age of the apheresis (Fig. 1). As the age of the apheresis increases, the viability decreases. Therefore, care should be taken about the age of the apheresis. A correlation between the DMSO contact time and the viability of the end products after thawing was not observed (Fig. 2). Conclusion(s): GMP-compliant closed system manufacturing of cryopreserved allogeneic stem cell products provides safe and high quality drugs that can be used for transplantation. We have shown that with our manufacturing process, DMSO, which is potentially toxic to cells, has no effect on cell recovery after thawing. Cryopreservation is therefore a suitable and safe method to provide patients with essential therapy worldwide. (Figure Presented).
ABSTRACT
SESSION TITLE: Studies on COVID-19 Infections Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/18/2022 01:30 pm - 02:30 pm PURPOSE: Beyond conventional risk factors, studies suggest acute viral infections, including influenza, are a potential risk factor for development of acute cardiovascular (CV) related events such as acute coronary syndrome (ACS) and stroke. On Mar 31st, 2020, the Texas state governor instated a shelter-in-place or quarantine order. With social distancing and masking the exposure respiratory viral illnesses dropped. This study seeks to evaluate the impact of reduced viral infections on CV related events. METHODS: A retrospective chart review of patients admitted to 18 affiliated Baylor Scott & White Texas hospitals in north and central Texas from January 20th, 2020 to Jun 1st, 2020 and between January 20th, 2019 to Jun 1st, 2019. We defined the pre-quarantine period as January 20, 2020 – March 31, 2020. The quarantine period was defined as April 1, 2020 – Jun 1st, 2020. We investigated ACS and stroke risk associated with lab-confirmed respiratory virus panel- PCR (RVP) positivity using a self-controlled case series. RVP positivity was reviewed to determine the presence or absence of increased risk interval. Risk intervals were identified as 7 days after respiratory specimen collection and associated control intervals were one year before and one year after the risk intervals. RESULTS: There were 3,782 patients who had ACS or stroke from January 20th, 2020 to June 1st, 2020. Average monthly rate of positive viral infection was significantly lower during the state mandate social distancing period than before social distancing mandate (5.5 ± 4.6 vs 19.7 ± 4.2, p<0.0001). During the prequarantine period, for stroke, there was a significant difference in positive RVP between the prequarantine and quarantine period (10.8% vs 0%, P=0.009). For ACS, there was a significant difference in positive RVP between the prequarantine and quarantine period (16.2% vs 1%, P<0.001). Rhinovirus infections accounted for 67% of patients of stroke prequarantine. Influenza accounted for 40% of infections in patients with ACS. Admissions for CV related events were higher in the pre-quarantine period compared to the quarantine period (893 vs 695 strokes;1,227 vs 967 ACS). Patients in the pre-quarantine and quarantine were similar in age and gender. For stroke, there was no significant difference in the type of stroke between the two time periods with ischemic stroke occurring in 67% of patients. For ACS, there was no significant difference in type with non ST-elevation MI occurring in 44% of patients. There was no statistical difference of survival to discharge or readmission at 30 days between the two periods. CONCLUSIONS: In our multicenter study, we note significant decline in cardiovascular events due to viral illness. This study strengthens the association between viral infections and cardiovascular events. CLINICAL IMPLICATIONS: This study reveals implications of cardiovascular events following viral illness. DISCLOSURES: No relevant relationships by Tayler Acton no disclosure on file for Alex Arroliga;No relevant relationships by Jason Ettlinger No relevant relationships by Shekhar Ghamande No relevant relationships by Mufaddal Mamawala No relevant relationships by Abirami Subramanian No relevant relationships by Heath White