Bio-CELL 6.0 is applicable to the clinical pilot and large-scale production stages of Cell and Gene Therapy enterprises. Its product traceability function is combined with Bio-CELL production (MES), inspection (LIMS), QA and other functions, and integrates data such as "R&D, production, experiment, and quality control" in all aspects to ensure the product safety, compliance, controllability, and traceability, realizing the goal of no dead corner management in the whole life cycle of Cell and Gene Therapy.
The unique code of cell preparation runs through the whole cell life cycle. From the entry of the application form, it goes through the steps of sample transportation, sample reception, production reception, production planning, production, frozen storage, recovery, passage, and outsourcing. After the release of finished products, it finally completes the cell transfusion, forming a two-way traceability Chain of Custody (COC) and Identity Chain (COI).