Consulting

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.

 

Our consultants have decades of experience and can assist by performing short term tasks or becoming an embedded member of your project team.  

 

  • 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 

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