PLUS™ HPL Cryobag, GMP

PLUS™ human platelet lysate is made from large pools of transfusion grade human platelets sourced from FDA-registered/AABB accredited blood centers, negative for infectious diseases. ​PLUS™ supports the culture of many human cell types, including mesenchymal stromal cells (MSCs) derived from multiple tissue sources (bone marrow, adipose, umbilical), dendritic cells, dermal fibroblasts, epidermal keratinocytes, T cells, NK cells, and endothelial cells. 

Features:

- Fibrinogen-depleted and xeno-free
- Large batch sizes with flexibility for customization
- Manufactured under cGMP compliance 
- A Drug Master File (DMF) is available with the US FDA
- Used in clinical trials worldwide

GMP-grade PLUS™ hPL has been used in numerous Phase 1 to Phase 3 clinical trials in North America and Asia. Autologous and allogeneic cells cultured in GMP PLUS™ have been administered to patients as part of IND approved clinical trials for various indications such as cystic fibrosis, rheumatoid arthritis, osteoarthritis, and hematological malignancies.

Standard quality testing includes donor material for infectious diseases as well as final product testing for biochemical properties, bacterial and fungal contamination, mycoplasma and endotoxin levels, and MSC growth.

Keywords: hPL; cell culture media; human platelet lysate; GMP grade hPL; GMP grade human platelet lysate; PLUS hPL; stem cell culture media; cryobag hPL; cryobag human platelet lysate, MSCs, rapid cell growth