GMP grade PLUS™ is manufactured under cGMP compliance to ensure proper design, monitoring and control of the manufacturing processes, facilities, and the final product.
GMP PLUS™ is available in bags or bottles. GMP PLUS™ in bottles is a lower cost, flexible product format for incorporation into manufacturing protocols, and GMP PLUS™ in bags is considered a preferred option for use in clinical protocols that have been automated or use bioreactors for large scale manufacturing.
Product Testing and Release Criteria - In addition to the standard testing of donor material for infectious diseases; every Lot of final product is tested for biochemical properties, bacterial and fungal contamination, mycoplasma and endotoxin levels, and MSC growth.
Drug Master File - A Drug Master File (DMF) for GMP PLUS™ hPL is on record with the US FDA to support our US customer’s regulatory submissions to the FDA. PLUS™ customers may make a request to Compass Biomedical to reference the DMF in their submission.
GMP PLUS™ hPL in Clinical Trials - GMP 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.
If you would like to have a more detailed technical discussion about adopting GMP PLUS™ into your cell therapy protocol, please contact [email protected]. We are happy to work with you and provide the documentation needed to advance your research and development efforts.
GMP PLUS™ is available in bags or bottles. GMP PLUS™ in bottles is a lower cost, flexible product format for incorporation into manufacturing protocols, and GMP PLUS™ in bags is considered a preferred option for use in clinical protocols that have been automated or use bioreactors for large scale manufacturing.
Product Testing and Release Criteria - In addition to the standard testing of donor material for infectious diseases; every Lot of final product is tested for biochemical properties, bacterial and fungal contamination, mycoplasma and endotoxin levels, and MSC growth.
Drug Master File - A Drug Master File (DMF) for GMP PLUS™ hPL is on record with the US FDA to support our US customer’s regulatory submissions to the FDA. PLUS™ customers may make a request to Compass Biomedical to reference the DMF in their submission.
GMP PLUS™ hPL in Clinical Trials - GMP 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.
If you would like to have a more detailed technical discussion about adopting GMP PLUS™ into your cell therapy protocol, please contact [email protected]. We are happy to work with you and provide the documentation needed to advance your research and development efforts.
Bottled Human Platelet Lysate Options
PLSGB 25 mL |
PLSGB-0100 100 mL |
PLSGB-0250 250 mL |
PLSGB-0500 500 mL |
PLSGB-1000 1000 mL |
Cryobag Human Platelet Lysate Options
PLS5 100 mL |
PLS6 250 mL |
