Consulting

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Pluristyx provides contract consulting services in the cell therapy and advanced biologics field with expertise in process & analytical development, GMP manufacturing, process transfer & scale-up, facility design & operations, regulatory support, IND/BLA submissions.  Our passion is helping to translate bold ideas into revolutionary products.



 

  • CDMO selection and management

  • Process transfer

  • Process design and development

  • Analytical method development

  • CMC project management

  • Raw material supply chain and quality 

  • Manufacturing facility design & operations

  • Risk analysis and failure investigations

  • Technology evaluation and due diligence

  • Automation

  • Experimental design and data analysis

  • Financial modeling and cost of goods analysis

  • IND/BLA content

  • Training and education

  • Manufacturing Strategy

  • Company start-up