Our technology transfer services ensure smooth scale-up of chemical processes
Our team of process engineers work alongside process development chemists to evaluate and prepare processes for scale-up. Full-fledged process safety evaluations ensure the operators are not put at risk and the product can be produced in-spec.
Why choose Sai?
- Team of process engineers closely working with the chemists during development
- Team of tech absorption engineers at the site to understand the process needs and retrofit plant in parallel
- Full-fledged process safety evaluation capability
- Scale-up facility at the R&D centre to mimic plant conditions
- Detailed checklists and SOP for tech transfer
How does it work?
The success of the Sai Life Sciences Tech transfer group lies in the strength of the collaboration and implementation of best practices. Our process development & analytical chemists are paired with our process and absorption engineers. The process engineers are involved with route selection choices, providing insight on the scalability of each unit operation.
Once the route is finalized, optimization is carried out keeping in mind the scalability and robustness of the process. Speed, scalability and safety are the focus for early phase projects. As a program graduates to later clinical phases, the teams then revisit the process to build in robustness and optimize efficiency.
Our tech package consists of process chemistry, analytical and HSE sections when ready for initial scale-up. Chemistry is first scaled in our GMP kilo-labs or Process Engineering block at the Research & Technology centre with results incorporated into the tech package.
An in-depth discussion takes place between all the stake holders, facilitated by the project management team to capture all risks and mitigate them. A Pre start up review is done at the execution site with all concerned to ensure the suitability of the setup.
Process engineers, chemists and analysts team up with the tech absorption team to provide 24-hour coverage for the first campaign of a newly scaled process. Process engineers remain to demonstrate 4-5 successful batches, then the tech absorption team takes product ownership until a process is validated.
A report is generated following each campaign incorporating risks, challenges and recommended improvements for investigation.