The CliniMACS Cell Factory® for parallel cell and gene therapy manufacturing

Our network of cell development and manufacturing facilities is based on Miltenyi Biotec’s well-established CliniMACS Cell Factory concept. By leveraging our own cell manufacturing technologies, automated workflows, ancillary GMP materials, and services, Miltenyi Bioindustry provides consistently high-quality cell products, wherever you work. 

The CliniMACS Cell Factory – a standardized, yet fully configurable facility design

Flexible enough to be tailored to your specific production needs, the CliniMACS Cell Factory drastically reduces the challenges of process up- and out-scaling. With the CliniMACS Prodigy® Platform and the MACSQuant® Analyzer at the core, all our cell manufacturing locations worldwide are built and equipped on this same principle for consistent manufacturing and analytical processes. Harmonization among all instruments allows for an easy technology and assay transfer around the globe. Moreover, because we rely on Miltenyi Biotec’s high quality ancillary materials, we can reduce external supply chains and product variability. For you, this means working with us will help lower regulatory hurdles, accelerate process development, and meet all manufacturing requirements.

Regardless of your expertise, product maturity, or whether you are planning centralized, point-of-care, or decentralized manufacturing, you use the CliniMACS Cell Factory Blueprint that supports your development of a scalable and rapidly deployable facility concept.

  • Capitalize on automated and integrated instrument platforms
  • Closed systems minimize cleanroom requirements to Grade C or ISO 7/8
  • Parallel manufacturing at any scale
Dr. Iris Bürger, Senior Director CliniMACS Cell Factory, Miltenyi Biotec

Insights from our CliniMACS Cell Factory Senior Director

“The world’s first CliniMACS Cell Factory was piloting our unique concept of a highly sophisticated and integrated pharmaceutical manufacturing concept for cellular therapeutics. We standardized parallel manufacturing of multiple cell products in one clean room with our fully automated CliniMACS Prodigy platform.

“We thereby supported and accelerated clinical development of innovative therapies against cancer. By rolling out this concept in more and more instances and enabling other ready-to-use-facilities, we demonstrated that automated manufacturing is easily transferable, robust, and successful in gaining approval for different regulatory competencies throughout the world. Continuous development and further improvements for industrialization of manufacturing processes and safety of cellular products aim to efficiently provide promising therapies to patients by ourselves, our adacemic partners, and our industrial partners.”

Cell processing and analytics

Turning a working process into a commercially viable one

The gap between ‘working in theory’ and ‘producing at scale’ is one that presents a challenge to the commercial viability of many innovative CGT approaches. In combination with well-established instruments, the CliniMACS Cell Factory concept optimizes your CGT workflow to save you time and money and enables parallel manufacturing of different clinical cell products in one room. And the earlier in process development your equipment configuration is clear, the faster and easier your transition to the commercial phase will be. This should also include analytics for process control and product quality, as well as critical material supply and servicing. We can help you in the transformation.

  • We transfer your manual process to clinically-proven technologies
  • Increase process robustness through instrument automation and integration
  • Meet bioprocess excellence

 

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The CliniMACS Cell Factory – Clinical-scale manufacturing of cell and gene therapy products

The CliniMACS Cell Factory brings clinical-scale cell manufacturing to the next level. Our scalable, automated, and closed-system cell processing platform reduces cleanroom requirements and enables parallel manufacturing of patient material on multiple instruments – in one room.