Cell and gene therapy process development

Dedicated process development is at the heart of our work, and underlies the foundation for robust, standardized, and scalable cell and gene therapy (CGT) manufacturing solutions. Using our proven cell manufacturing platform, we have designed cell manufacturing processes used to process thousands of immune- and HSC-based gene therapy products. Take advantage of our extensive experience and let’s tailor your processes into lasting and robust solutions.

CGT process development with the CliniMACS Prodigy® Platform

At any stage of your journey and at any level of experience, we can help you develop optimized CGT process workflows. Parallelized process design and development on the automated and closed CliniMACS Prodigy Platform and MACSQuant® Analyzer help to achieve a cost-efficient and scalable procedure that can serve as a common platform from research to clinical development and on to commercialization. An iterative process of optimization, material generation, and characterization culminate in a refined manufacturing process to meet the requirements for IND filing. 

We generate the necessary documents and reports for seamless industrialization:

  • Creation of Manufacturing Production Records (MPRs), Standard Operating Procedures (SOPs), work instructions, and forms executed via experimental protocol and documented in technical reports intended for regulatory submission
  • Identify, build, and optimize bill of materials (BoM), leveraging Mitenyi’s robust clinical product catalog, supported by our qualified vendors where needed

 

From standard processes to the most unique – we take it in stride

We customize protocols to your specific needs that turn our equipment into true platform solutions for CGT products. We’ve already developed more than 300 customized applications that are now used in daily routines around the globe, and we welcome the opportunity to discuss yours. We have mastered the complexities of cell processing and have a long track record to prove it. As a result, we build efficient and scalable processes at every stage of product development – from research use only to GMP supportive and CE-certified protocols.

  • Complement standard applications
  • Tailored to your specific needs
  • Enable new applications and processes
  • Available from Research (PD/RUO) to GMP supportive CAPs

 

Let’s talk about how we can help you