GMP Products are manufactured and tested under a quality management system (ISO 13485) and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials.
Every processing step from development to production and quality control (QC) testing is extensively documented and no animal-derived materials are used to manufacture these products.
- Lot-to-lot consistency
- Extensive stability studies
- Assured supply
- Vendor qualification of raw materials
MACS GMP Products support the transition from research to clinic and help make cell therapies a clinical reality.