Moving towards commercial scale in cell and gene therapy

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.

We enable technology transfer to your preferred manufacturing site

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.

  • Minimize the time and cost to achieve commercial manufacturing
  • Technology and assay transfer to your preferred CMO or internal manufacturing team
  • Our cell therapy CMO/CDMO sites include trained and audited member organizations for streamlined process transfer

 

Our global service and training programs

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.

  • We are there for you – wherever, whenever
  • Profit from our global 24/7 Technical Support and Instrument Services
  • We train your operators on CliniMACS® and MACSQuant® Instruments for the implementation of your specific SOPs

We support your capacity expansion from plant layout to material supply

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. 

  • Gain full control by setting up your own manufacturing space
  • We help you right-size your footprint with modular manufacturing suitable for adapting capacity to demand
  • Capitalize on established room layouts, equipment, processes, materials, training, and services in compliance with your local regulatory requirements

Our CMC regulatory support for a safe, effective, and consistent cell product

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.

  • The CliniMACS Prodigy Instrument is accepted by more than 50 authorities worldwide
  • We provide Product Information Files (PIFs) for ancillary material such as MACS® GMP Cytokines to support your clinical trial application
  • We supply documentation to support regulatory filings, including process mapping, process description, and theoretical calculations for washout efficiency of impurities, and other parameters.
  • We offer full protocols and reports for engineering, process qualification, assay qualification, aseptic processing qualification, storage and in-use stability, and process monitoring

Let’s talk about how we can help you