MACI is manufactured in accordance with quality GMP standards

Assay testing

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

manufacturing safety

MACI MANUFACTURING: RIGOROUS SAFETY PROTOCOLS

  • MACI is aseptically manufactured from a patient’s autologous cells in an FDA licensed facility using only sterile materials.
  • Manufacturing clean rooms maintain the highest cleanliness standards through automated environmental controls and monitoring.
  • Each phase of manufacturing is monitored and tested for microbial contamination.
  • Our scientists and engineers are protected by pre-sterilized gowning materials, ensuring the safe production of MACI.

How exactly does the MACI procedure work? Find out here