Stemulate®

Rely on Stemulate

For optimal cell therapy manufacturing, you need a culture media supplement that provides rapid expansion of high efficacy cells while meeting quality and regulatory expectations. Stemulate is a human derived growth media supplement with proven success across multiple cell types.

Evaluate HPL

Performance

• Increased expansion of cells compared with supplements such as FBS and Chemically Defined media
• Maintains downstream MSC phenotypes.
• Highly consistent across lots allowing for reproducible manufacturing of cell product
• Performance in both 2D and 3D culture systems
• Ease of transition from Research to Clinical grade versions allow for incorporation at an early stage of clinical development without burdensome revalidations at later stages

Quality

• Manufactured under a certified ISO9001:2015 Quality Management System
• Certificate of Analysis Documenting testing for Sterility, Endotoxin, Mycoplasma
• BM-MSC growth verification assay for Clinical Grade product
• Certificates of Origin and Compliance available
• Sexton Biotechnologies supports regulatory filing and audits of the process or facility

Regulatory

• Manufactured from expired apheresis platelet units sourced from AABB-accredited and FDA-registered blood centres
• Raw materials meet FDA and AABB requirements for platelet transfusion
• Full donor traceability
• TSE Statements, COC and Non-animal component statements available