Do you want to upgrade your IPC/QC and increase product safety for ATMP production? Our new clinical flow cytometry software comes with advanced user management and data traceability. Bring your cell analysis on the next level and in compliance with ALCOA+ principles.
Data integrity is a challenge to the pharma industry, as the cell and gene therapeutics manufacturing equipment has been computerized. The duty to assure data integrity results from 21 CFR Part 11 and Eudralex GMP Annex 11 regulations, that apply to computerized systems used in GMP areas. Here, at Miltenyi Biotec, the combination of the new closed operating system called MBCore, together with the data acquisition software MACSQuantifyTM, delivers all necessary onboard tools and features to simplify meeting these compliance requirements by instrument design.
Miltenyi Biotec is a global provider of products and services that empower biomedical discovery and advance cellular therapy Our innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Our technologies enable solutions for cellular research, cell therapy, cell manufacturing, and imaging. Our 30 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer, and clinical research areas like hematology, graft engineering, and apheresis. In our commitment to the scientific community, we also offer comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec more than 3,000 employees in 28 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.
