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