For many years, our company is dedicated to the development of a highly efficient and effective process for the large-scale production of active pharmaceutical ingredients (APIs) in kilogram-scale laboratories. With a team of highly skilled and experienced experts in API pilot testing, we offer comprehensive solutions to help our customers design an accurate API pilot scale-up process, enabling them to smoothly transition into industrial-scale production. If you are in need of enlarging the production volume of your API, please contact us.
Our Services
In the API production process, although the nature of chemical synthesis reactions does not change due to different production scales, the optimal process parameters for each step of the chemical reaction may change due to different external conditions such as experimental scale, operation process, and production equipment. This may lead to an increase in impurities, which can affect the yield and quality of the API.
At our company, our experienced scientists follow experimental design (DoE) to thoroughly evaluate the safety, efficiency, purity, cost, ease of scale-up, and safety of the raw material supply of the laboratory-scale synthesis process. We can determine the optimal process parameters, material quantities, and consumption for pilot-scale production processes. This can help you shorten the development cycle, reduce development costs, and achieve industrial production of APIs.
What We Can Do?
| Verify if the small-scale process is reasonable and the intermediate and final product synthesis processes are close to production requirements. |
| Verify if there are any special requirements for the process route (such as reaction conditions and post-processing operations) provided by the laboratory when scaling up to pilot production and if it is suitable for industrial production. |
| Determine the specifications or standards for the starting materials, reagents, or organic solvents used. The specifications of the materials and reagents used in the pilot production should be consistent with those used in industrial production. |
| Select the materials and models of the production equipment involved in the process. |
| Determine the type and requirements of the stirrer and stirring speed in the reaction vessel. |
| Determine the type and requirements of the heating/cooling carrier (such as steam, hot water, or brine). |
| Determine the heat transfer and mass transfer requirements for each step reaction, as well as the impact of feeding methods and feeding rates on the reaction. |
| Determine the optimal process parameters for each unit reaction under pilot equipment conditions, as well as the side reactions in each unit reaction. |
| Further investigate and improve the process parameters for each step to ensure stable data for each reaction and unit operation, and establish material balance and standard operating procedures. |
| Establish a waste treatment plan. |
Advantages
- Following DOE, we can gain a better understanding of the process in a shorter time and shorten the development cycle of API production.
- We have professional pilot-scale experimental equipment and are able to produce APIs ranging from 1 to 20 kilograms.
- Experienced professionals in the project can optimize the pilot process route to the greatest extent and can identify potential safety risks in the process.
Delivery
| Complete pilot route and process parameters | Chemical and physical properties of raw materials and intermediates |
| Chemical and physical properties of impurities | Yield and purity of API |
| Programs for the treatment of wastes | Other experimental data |
Please kindly note that our services are for research use only.
