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End-to-end Solutions to Enable Genomic Medicines
Precision NanoSystems provides a full stack of technologies and solutions with leading experience to accelerate the design, development and manufacturing of promising Genomic Medicines.
Precision NanoSystems Framework provides a roadmap for genomic medicine development. The specific Workflows for development of vaccines, gene therapy and cell therapy are designed to accelerate genomic medicine development by using the Framework together with components of the Genomic Medicine Toolkit to increase effectiveness and efficiency across the drug development process.
Precision NanoSystems Genomic Medicine Development Framework
Validate molecular target(s) in vitro/vivo
Screen sequence, base modifications and excipient library
Systematically test process and formulation parameters to physico-chemical properties and in vivo biological activity
Down-select lead formulations and optimize key process parameters
Additional animal studies in second species to assess efficacy and toxicity
Process and formulation parameters & analytical methods to ensure product quality and performance are developed and finalized
GMP equipment, manufacturing process, analytical methods and QMS transferred into Clean Room Facility and validated with engineering run.
Investigational New Drug (IND) application submitted
GMP batch production of Nanomedicine for clinical testing - Phase 1, 2 & 3
Instrument, process and analytical methods transferred to commercial production site
New Drug Application (NDA) submitted
Commercial production of Nanomedicine initiated