When the pressure to manufacture your cell and gene therapy (CGT) product for clinical trial initiation is at its greatest, you can count on us. We support you with our expertise and technology to manufacture, analyze, and release your CGT product. Our equipment, material, reagents, and protocols have been widely used for clinical and partially for commercial manufacturing around the globe.
We use automated manufacturing technologies and analytical assays proven in numerous different clinical trials. This reduces the risk and time required to reach your critical project milestones. We work with each customer to determine if existing workflows can be implemented or to develop a manufacturing process tailored to your needs as appropriate, leveraging our decades of expertise to streamline production. This can even include the integration of third-party materials and equipment to support the successful manufacturing of your CGT product.
The automated and closed CliniMACS Prodigy® processing platform and MACSQuant® Analyzer Platform – in combination with GMP materials, reagents, and protocols – are designed to meet your needs for a cost-effective and scalable process. As a result, our solution can be used from process development to clinical trial material production and supports commercial manufacturing. The closed nature of the platforms enables true parallel cell manufacturing in a cost-effective ballroom concept in cleanroom Grade C or ISO7/8 conditions. To support your goals, this manufacturing model is also reflected in the CliniMACS Cell Factory® concept for commercial manufacturing. Reach out to us and we will be happy to support your efforts by expanding your manufacturing capabilities.