Early phase scale-up
Phase-appropriate development & manufacturing services for pre-clinical and phase-I NCEs
We support innovator companies with quick and effective services in phase-appropriate development and manufacturing of pre-clinical and phase-I NCEs.
- Laboratory reactors: 2L to 10L
- Kilo lab suites: 64L to 250L at the Research & Technology facility
- Process engineering production block mimics larger scale equipment
- Reactor sizes of 64L to 3KL also available
- 250L and 1KL reactors to handle cryogenic conditions
- Hydrogenation capacity from 1L up to 1KL
- Cleanrooms and high potency suites
How does it work?
The team engages in quick familiarization and minimal optimization to meet the scale-up needs and fast-paced timelines of our clients. The early phase team bridges the medicinal chemistry team and later phase process development teams to ensure a quick progress through the development phases, which includes supporting IND submissions and technology transfer.
Sai Life Sciences incorporates process safety testing and utilizes equipment that closely mimics that of our larger commercial equipment. An additional facility dedicated to early phase projects will bolster our capacity when online in October 2020. The quality systems defined for the early phase manufacturing approach helps handle documentation, process deviations and investigations in a quicker, which in turn helps deliver product faster. The same phase appropriate development approach is adopted by the analytical research and development team in the method developments and stability studies. With 60+ early phase programs delivered in the past 10 years, our project teams provide clients with best practices to meet the requirements for pre-clinical and Phase 1 clinical programs.