Sartorius, 1017-1000, CellGenix® rh TPO (GMP Grade)

Top Features for Recombinant Human Thrombopoietin: Optimal use of expansion of HSC's ADCF Level 2 High purity to ensure the safety of your process Available in two different grades (Preclinical and GMP grade) Preclinical grade: CellGenix® Recombinant Human Thrombopoietin (TPO) is an animal-derived component-free product. It is produced in a dedicated animal-free GMP facility. TPO is used in the cell and gene therapy space for the ex vivo expansion and differentiation of hematopoietic stem cells (HSCs). GMP grade: CellGenix® Recombinant Human TPO is produced following applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043>, Ph. Eur. General Chapter 5.2.12 and ISO 20399:2022. CellGenix® GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts. Expiry: ≥ 6 months from date of shipping. We have submitted Drug Master Files (DMFs) to US Health Authorities to support our customers’ regulatory activities. These Master Files can be cross-referenced through Letters of Authorization (LOAs) in Marketing Authorizations, IND, BLA, NDA, ANDA or other DMF applications. Please submit your Authorization Request via the form above. Preclinical grade: Designed to meet the demands of translational research, CellGenix® Preclinical cytokines are ideal to bridge the gap between the lower quality of research grade and the higher costs of GMP grade materials. Expiry: 3 years from date of shipping For the exact expiry date and the batch specific activity, please refer to the Certificate of Analysis on the My Sartorius Portal. Safety Data Sheets (SDSs) are available on request. Specifications Applications: Application Area: Cell & gene therapy; Thrombopoiesis Cell Type: HSC; NK Cells; ESC/iPSC Intended Use: For further manufacturing use Biological Information: Activity: 10 – 40 x 106 U/mg Compliance Information: GMP Compliance: This product was manufactured in accordance with applicable Good Manufacturing Practice (GMP) guidelines. Origin: Animal-Component Free Quality Grade: GMP Features: Carrier-Protein Free: Yes Physicochemical Information: Endotoxin: ≤ 0.05 EU/µg Expression System: E. coli Formulation: Lyophilized from a 0.2 µm-filtered aqueous solution Product Information: Brand: CellGenix® Package Type: Vial Size: 1 mg Sterility/Purity: Delivery Condition: Sterile Purity: ≥ 97% Weight: Molecular Weight (kDa): 19.6 kDa