For over 25 years, Miltenyi Biotec has played a central role within the cellular research and therapy community. We utilize our time-proven technology and resources to develop, optimize, and engineer robust GMP cell manufacturing processes that are specifically tailored to our customers’ cell therapy needs.
Our flexible infrastructure enables us to change and expand to accommodate the needs of our customers from small pre-clinical scale up to commercial scale. Alternatively, we can transfer our technical know-how to enable in-house manufacturing of your own therapy. Applying our expertise in customizing and automating cellular production to your cell manufacturing processes will accelerate your programs towards the clinic. Furthermore, with strategically located GMP cell manufacturing facilities in the US and Europe, we are well situated to support your needs in many regions.
• Process development and cellular product manufacturing using our scalable and automated CliniMACS-based technologies for clinical trials and commercial uses.
• US and European-based GMP manufacturing facilities enabling close logistical proximity to key markets and operational continuity.
• Quality control and quality assurance systems to certify the release of safe, consistent and potent cell therapy products.
• Segregated GMP Controlled Environment Room (CER), ISO 7 suites with separate air handlers and terminal HEPA filters.
• Registered with FDA for human cells and tissues product (HCT/P) processing and licensed by the state of California for investigational drug manufacturing.
• Global regulatory support.