Success Story: Piramal’s Route Scouting Strategy is a Speedy Solution for Customers in the Early Phase Development of APIs.
The route scouting team at PDS supplied 100g of API for early phase clinical trials to a customer. Some of the noteworthy features were the medicinal chemistry route was non-scalable, unsafe and used Palladium cross coupling reaction at the last stage contributing to a high manufacturing cost apart from a potential stability issue of the final molecule.
The PDS route scouting team designed a shorter, safer route that was robust and scalable which bypassed the use of Palladium and in the process ensured the stability of the final molecule.
The new route was shorter by two steps and had an overall yield improvement by 6X with an improved purity of 99.5 %
Comparison of Med Chem Procedure vs Current Process.
| No. | Comparison points | Med Chem. Procedure | Route Scouting Process |
| 1. | No of Chemical steps | 8 | 6 |
| 2. | No of Column chromatography | 6 | 0 |
| 3. | Overall yield | 2.9 % | 18.9 % |
| 4. | Metals catalysis | Yes | No |
| 5. | Process | Complex | Simple and scalable |
To achieve this exceptional success the route scouting team ensure the following:
- Speedy literature search and proposed 3 new synthetic routes.
- Parallel optimization of the selected route to ensure delivery of the API with high purity.
Basis of the route scouting delivery the client has since requested for multi kg scale up quantities (GMP and non-GMP) from Piramal API services which would be scaled up at Ennore (India) and Torcan (Canada).
Customer feedback: “It is a great accomplishment and very impressive”.