Process Development

Process Development
Product Description

BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts.
Services Areas:


Route Design & Evaluation

  • Design & evaluate potential synthetic routes
  • Material & production cost analysis of each route
Process Optimization
  • Condition screenings
  • Modification work-up & isolation process
  • Short-path distillation, column purification
Process Characterization
  • Impurity profile controls (purge/fate)
  • Characterize of Critical parameters (IND enabling)
  • Safety assessment, PGI impurity controls
Scale-Up Demonstration
  • Demonstrate the process on kilo scale
Reaction Engineering
  • Isolation and crystallization studies such as solvent screening and selection and solubility study
  • Impurity profile controlling such as impurity structure elucidation and impurity purge/fate
Enabling Technologies
Flow Chemistry
  • Special knowledge
  • Diverse reaction types
Carbohydrate Chemistry
  • Complex structure & sensitive molecules
  • Mono-saccharide synthesis experience
  • Isolation & purification techniques
Peptide Chemistry
  • Unnatural amino acids synthesis
  • Assembling strategy for cost & quality controls
  • Kilo scale synthesis up to 5-6 amino acid

BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service

BioDuro-Sundia

  • US
  • 2018
    On CPHI since
  • 2
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service

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