PRE-CLINICAL AND LATER STAGE API TECHNOLOGY DEVELOPMENT
ADI CHEMTECH Pharma 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 Pharma 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 Pharma’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 Pharma’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 Pharma 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 pharma 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
- 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 Pharma also provides process chemistry and analytical development services for troubleshooting process issues.