Case Study: Delivering technical solutions to complex chemistries
Customer need
- Development of complex API with 4 stereogenic centers for clinical trials and filing
- Subsequent supply of commercial quantities
What we did?
- Conducted 10+ chemical steps with non-selective chemistry which yielded 1:1 diastereomeric mixture. All intermediates were oily
- Conducted 20+ chromatographies to generate 20 g lab sample
- Successfully developed 2 different selective routes to produce API without chromatography and manufactured multiple batches in kilo lab for clinical supplies
- Selected preferred route for validation based on economics, process robustness and product quality
- Streamlined the process to 4 isolation steps
Value to the customer
- Multiple routes developed for complex API development - range of options to select optimal process
- Support from clinical batches production to filing to commercial production
Case Study: Delivering cost value proposition
Customer need
- API Manufacturing required at Torcan
- Cost saving through sourcing of starting material from off-shore vendors, particularly China
What we did?
- Audited Chinese suppliers for starting material - discovered inconsistencies in quality with respect to audited China suppliers
- Initiated and completed parallel development of the starting material at the Indian site (Ennore) for ensuring that API development was not affected
- Certified Ennore as a qualified supplier after audit
- Delivered cost competitive API with quality assurance through in-sourcing
Value to the customer
- Cost saving delivered along with quality assurance through in-sourcing
- Timely delivery of API through ownership of process from the sourcing stage
Case Study: Ensuring supply
Customer need
- Timely delivery of GMP API for clinical studies with stringent deadlines
- Reliable supply of API for scale-up and commercial scale with quality assurance and additional cost benefits
What we did?
- Developed process and delivered 1kg API from our GMP location at Torcan
- Leveraged India site (Ennore) for in-sourcing non-GMP requirements at scale-up and further stages
- Ensured technology transfer through coordinated efforts for in-sourcing, logistics and quality assurance
Value to the customer
- GMP API supplied in time to meet clinical requirements
- Consistent reliable supply of API with assurance of quality and cost saving for scale-up and commercial quantities