Cell Freeze Media |
CryoStor®產品為一系列最優化的細胞凍存液,專為在超低溫度的環境下 (-80 到 -196ºC) 保存細胞所設計。CryoStor®內含不同濃度DMSO,於 冷凍保存的過程中透過調節分子生物反應,為細胞和組織在凍結、存儲和 解凍過程中提供一個安全與保護的環境。CryoStor®在不含血清、蛋白質 和其餘高含量細胞毒性藥物下增強細胞活力和功能。所有原料皆為美國藥 典 (USP) 等級,在符合cGMP規範下製造生產。為無血清、無蛋白質、無 動物來源成分的細胞凍存液 ⦿ 已申請通過美國FDA DMF原料藥主檔案 。 |
Product | Cat. No. | Size | |
---|---|---|---|
CryoStor® CS2 | Pre-formulated with 2% DMSO | 202102 | 100 mL bottle |
CryoStor® CS5 | Pre-formulated with 5% DMSO | 205102 | 100 mL bottle |
CryoStor® CS5 | Pre-formulated with 5% DMSO | 205373 | 10 mL vial |
CryoStor® CS10 | Pre-formulated with 10% DMSO | 210102 | 100 mL bottle |
CryoStor® CS10 | Pre-formulated with 10% DMSO | 210373 | 10 mL vial |
CryoStor® CS10 | Pre-formulated with 10% DMSO | 210374 | 16 mL vial |
CryoStor® CS10 | Pre-formulated with 10% DMSO | 210210 | 1 L bag |
CryoStor® CS10 | Pre-formulated with 10% DMSO | 210473 | 10 mL syringe |
TEST | METHOD | LIMITS |
---|---|---|
Visual Inspection | Visual Inspection | Clear to slightly yellow solution with no visible particulates |
pH | SOP 3006 | 7.5 to 7.7 |
Metabolic Activity Assay | SOP 5103 | Cell viability following preservation is ≧ 75% of cells preserved in the internal standard at Day 1 recovery following preservation |
Endotoxin | Kinetic Chromogenic USP <85> | ≦ 1 EU/mL |
Sterility | Membrane Filtration USP <71> | Sterile |
Product | Cat. No. | Size |
---|---|---|
BloodStor® 100 100% DMSO | 410301 | 50 ml bottle |
BloodStor® 100 100% DMSO | 410302 | 100 ml bottle |
BloodStor® 55-5 50% DMSO 5% Dextran 40 | 355371 | 5.6 mL vial |
BloodStor® 55-5 50% DMSO 5% Dextran 40 | 355372 | 7.2 mL vial |
BloodStor® 55-5 為符合cGMP標準的凍存液(Generic Product),內含55%(w/v) DMSO和5%(w/v)Dextran 40,專用於冷凍保存從臍帶血、周邊血、骨髓、與其他 生物製劑中分離出來的幹細胞和其他細胞。所有BloodStor產品皆使用美國藥典(USP) 等級原料和注射用等級水(WFI)。為無血清、無蛋白質、無動物來源成分的細胞凍存液。 55% (w/v) DMSO 5% (w/v) Dextran 40 USP/Highest Quality Components cGMP Manufactured Sterility, Endotoxin, and Cell-Based Release Testing |
Product | Cat. No. | Size |
---|---|---|
BloodStor® 55-5 50% DMSO 5% Dextran 40 | 355371 | 5.6 mL vial |
BloodStor® 55-5 50% DMSO 5% Dextran 40 | 355372 | 7.2 mL vial |