We support your expansion to commercial-scale manufacturing in multiple ways: You can choose your preferred manufacturing partner, select from our certified contract manufacturing organization (CMO) network to ensure a smooth technology transfer, or, alternatively, our experienced consultants can help you to internalize your own production capabilities based on our CliniMACS Cell Factory® ballroom concept. Along with technology transfer we offer dedicated training, instrument service, and technical support. In all cases, our service includes regulatory support for a safe, effective, and consistent cell and gene therapy (CGT) product.
Technology transfer is one of the core competencies of our service offering. Our Manufacturing Sciences & Technology (MSAT) group manages all outbound technology and assay transfer services. As such, we have established risk-mitigating approaches in accordance with Quality-by-Design (QbD) and regulatory guidelines and tools to enable rapid transfer into GMP. Thanks to our excellent partnerships and training programs with leading CMOs worldwide, we can offer our customers a seamless transfer to highly qualified and experienced partners on our Miltenyi Biotec platforms.
We offer powerful services and training. Our service includes global technical support as well as instrument and operational qualification services. Furthermore, Miltenyi Biotec’s training services are tailored to meet your specific needs, ranging from a “Instrument Introduction” and “Essential Training” to tailored “High-Compliance Training” that concludes with a training assessment and certificates that can be used in the validation process with your regulatory body. Learn with the High-Compliance Training to enable the transfer of your protocols from process development to cell manufacturing, including IPC/QC protocols, and contact us today.
Multiple CliniMACS Cell Factory sites are already operational, all based on the same concept of room layout and line clearance, equipment fitting, processes, raw material supply, training programs, and services. The scope is to enable bioprocess excellence and to optimize the use of costly cleanroom space. The core of the facility design is the CliniMACS Prodigy® Platform and MACSQuant Analyzer Platform for easy scale-out of production and supply of ancillary material. We can help you develop facility layouts and define space requirements, as well as staffing and equipment needs to meet specific processing and manufacturing challenges.
Meeting Chemistry, Manufacturing and Controls (CMC) regulatory requirements is key for a successful regulatory filing. We provide cross-reference letters to our Biologics Master Files (BMF) and have established Regulatory Support Files (RSFs) to support all process components required for CMC.