MACI is manufactured in accordance with quality GMP standards
RIGOROUS ASSAY TESTING PERFORMED PRIOR TO PRODUCT RELEASE
Viability Verifies a sufficient amount of viable chondrocytes for implantation is available
Identity Uses genetic markers to identify chondrocyte cells
pOTENCY Validating the ability to form a durable repair tissue
endotoxin Rapid macromolecule testing
mycoplasma The real-time PCR test approved worldwide
Growth, morphology, and sterility Prior to release, cells are assessed on these additional measures
ULU® Uniform loading ensures consistent cell delivery across the membrane.
Lot segregation Helps prevent cross-contamination between cell lots
Rapid sterility testing Used throughout the process to detect most organisms within 48 hours
How exactly does the MACI procedure work? Find out here