Speed to commercial readiness in cell and gene therapy

Speed to commercial readiness in cell and gene therapy

We’re here for you when the pressure to strap down a process for manufacturing your cell and gene therapy (CGT) or lentiviral vector product is at its greatest. We deliver a seamless clinical and commercial experience with unparalleled access to Miltenyi Biotec's cutting-edge technologies. We can shorten development time and greatly reduce technical risk while developing and producing through a commercially viable manufacturing process. 

Thanks to our global presence in key markets, we are also there for you wherever you need us.

A viable path to commercial CGT manufacturing

Key to a successful and accelerated time-to-market is our fully integrated end-to-end service for developing a commercially ready manufacturing process. In order to deliver a tailored and transferable cell manufacturing process, we work alongside you in a co-development model. Relying on our own high-quality ancillary materials, we’re independent of external supply chains and product variations. This includes our proprietary lentiviral vector platform for accelerated vector design and production. 

With decades of experience in cell and gene therapy, we have established ourselves as a global manufacturer of GMP-compliant lentiviral vectors. Our vector platform process has been proven in the successful production of more than hundred GMP batches per year. Reserve your GMP manufacturing slots today and contact our regulatory support team to get your product into the clinic and the market at your desired pace.

Together, and across our facilities, we use the same standardized platform technologies. This minimizes process development while meeting commercial manufacturing requirements. Moreover, our centralized project management team will guide you on your path to filing a new drug application (IND) or clinical trial application (CTA) towards market authorization submission, and help reduce any burdens associated with technology transfer and capacity expansion.

Access to the latest manufacturing and analytical technologies

Technology-driven advances will eventually make CGT products available and affordable to all. We’ve taken on this challenge and developed our technology platforms over decades. 

Today, we provide the advanced and well-established solutions that meet manufacturing needs: The CliniMACS Prodigy® Platform and MACSQuant® Analyzer. Integrated and fully closed manufacturing and QC platforms provide a cost-effective and scalable solution, designed to rapidly translate your process to clinical scale and beyond.

Following our vision of commercial manufacture, we’ve developed the CliniMACS Cell Factory® Concept. It is a blueprint of the ideal large-scale manufacturing facility for streamlined and harmonized parallel cell processing, scalable CGT production, and automated analytics. Our global CliniMACS Cell Factory sites have been built around this concept to help you access key markets. We share our learnings and can assist you in setting up a similar production facility right at your site. 

Contact us today to realize your vision of tomorrow's commercialization.

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