Product Overview
Leukopaks are highly-enriched leukapheresis-derived products obtained from an IRB-approved collection facility. Leukopaks contain higher concentrations of mononuclear cells, B cells, T cells, stem/progenitor cells, dendritic cells, and other cell types as compared to standard venipuncture collection methods or buffy coat products. Healthy, consented donors undergo a medical screening evaluation and are administered 5 doses of 10ug/kg TBW of Neupogen (filgrastim) on each of 5 days per IRB approved protocols prior to Leukapheresis. Leukapheresis is performed on the 5th and 6th day using the Spectra Optia® Apheresis System following IRB-approved protocols. MNC rich cells are continuously collected from 2-2.5 donor blood volumes into a sterile bag using ACD-A as an anticoagulant. Approximately 120mL of autologous plasma is automatically collected directly into the cell pool following leukapheresis. After a sample is withdrawn for quality testing, a nominal volume of 290mL is transferred into a sterile transfer bag prior to shipping. The total nucleated cell count is determined using AO/PI from the collection and provided as information. Cell counts and CD34 quantities will vary based on the donor’s response to mobilization. The total nucleated cell count is determined using AO/PI from the combined pool and provided as information. Fresh mobilized leukapheresis products typically contain up to 1% CD34+ cells, 40% granulocytes, and 5% hematocrit. Exact percentages will vary from donor to donor. Manufactured by AllCells® Additional shipping charges apply for fresh, human origin products
Leukopaks 是从 IRB 批准的收集设施获得的高度富集的白细胞分离衍生产品。与标准静脉穿刺采集方法或血沉棕黄层产品相比，Leukopaks 含有更高浓度的单核细胞、B 细胞、T 细胞、干细胞/祖细胞、树突细胞和其他细胞类型。健康、同意的捐赠者接受医学筛查评估，并在白细胞分离术前按照 IRB 批准的方案每 5 天给予 5 剂 10ug/kg TBW 的 Neupogen（非格司亭）。在第 5 天和第 6 天使用 Spectra Optia® 单采系统按照 IRB 批准的方案进行白细胞单采。使用 ACD-A 作为抗凝剂，从 2-2.5 个供体血液体积中将富含 MNC 的细胞连续收集到无菌袋中。在白细胞分离后，大约 120 mL 的自体血浆被自动收集到细胞池中。在抽取样品进行质量测试后，在运输前将标称体积为 290 mL 的样品转移到无菌转移袋中。使用集合中的 AO/PI 确定总有核细胞计数并作为信息提供。细胞计数和 CD34 数量将根据捐赠者对动员的反应而有所不同。使用组合池中的 AO/PI 确定总有核细胞计数并作为信息提供。新鲜动员的白细胞分离产品通常含有高达 1% 的 CD34+ 细胞、40% 的粒细胞和 5% 的血细胞比容。确切的百分比因捐赠者而异。由 AllCells® 制造 新鲜的人源产品需支付额外运费
Content & Storage
Content
1 bag