Pre-clinical and later Stage API technology Development

ADI ChemTech provides API (Active Pharmaceutical Ingredient) technology development services for the scale-up of complex small molecules for Pharmaceutical and Biotechnology companies.

Our core focus is process chemistry and analytical services for early stage development of pre-clinical and clinical candidates, where speed and quality are paramount.

As well, ADI ChemTech provides process chemistry expertise to later stage development programs where process economics, specifications, impurity profile characterization, regulatory strategies and supply chain management considerations are important. 

This focus provides ADI ChemTech’s Client's with a complete and comprehensive API technology platform to meet the developmental requirements from pre-clinical through phase III and for the successful technology transfer to manufacturing locations throughout the world.

.... providing the Right Development at the Right Time

ADI ChemTech’s talented chemists and staff provide phase appropriate solutions with the Client's immediate needs and milestones in mind, as well the long term commercial considerations.

Early Stage API Technology Development: Focus is on quality and speed

For early stage projects ADI ChemTech works closely with its clients to develop a development and manufacturing strategy for each compound, where speed and quality are paramount for business and regulatory reasons.

  • Pre-clinical – Phase I / II
  • Development Road Map
    • Short & Long-term Planning/Strategy
  • Phase Appropriate Development
    • Synthetic & Analytical chemistry
  • IND filing (CMC preparation)
    • Analytical & Specification Development
    • Product Characterization
    • Analytical Method Qualification/Validation
    • GMP and non-GMP Scale-up
    • ICH Stability
  • Early Stage Chromatography

Later Stage API Technology Development: Focus is Process Economics and commercialization

For projects that are proceeding into advanced clinical trials and towards commercialization, ADI chemtech provides transformative and comprehensive process chemistry development to ensure the client’s process will deliver a product that meets the appropriate process economic targets and regulatory requirements, upon full commercialization.

  • Phase II – Phase III / Commercial
  • Cost of Goods (COGS)
    • Route Selection
    • Process Development / Optimization
  • Analytical Development
  • Specification Development / Control
    • Characterization
    • Set and/or tighten specifications
    • Supply material for Bridging Toxicity Studies, if required
  • GMP and non-GMP Scale-up
  • Supply Chain Management
    • Regulatory Starting Material (RSM) Development & Manufacturing
  • Commercial Manufacturing
  • Technology Transfer

For large scale and commercial API manufacturing, ADI ChemTech also provides process chemistry and analytical development services for troubleshooting process issues.