- Overview
- Key Stages
- Our Services
- Choose Us
Overview
Active pharmaceutical ingredient (API) process R&D is crucial for the pharmaceutical industry as it directly impacts the quality, cost, and regulatory compliance of drug products. Our company has been deeply involved in the pharmaceutical industry for more than 20 years, and is adept at establishing commercial production processes through scientifically sound methods to consistently produce high-quality APIs. We are committed to providing comprehensive services to meet the diverse needs of our customers.
Key Stages
The process of API R&D encompasses several key stages:
Route Selection: Researchers evaluate various synthetic routes to determine the most feasible and efficient method for producing the target API. Factors such as cost, safety, environmental impact, scalability, and intellectual property considerations are taken into account during route selection.
Process Optimization: Once a synthetic route is chosen, the focus shifts to optimizing the chemical reactions, purification techniques, and operating conditions to maximize yield, minimize impurities, and enhance process robustness. Advanced techniques such as Design of Experiments (DoE), high-throughput experimentation, and computational modeling often accelerate optimization efforts.
Scale-Up and Technology Transfer: Successful laboratory-scale processes must be scaled up to commercial production levels while maintaining product quality and regulatory compliance. This involves transferring the technology from R&D laboratories to manufacturing facilities, addressing scale-up challenges, and conducting process validation studies.
Process Validation: Process validation involves demonstrating that the manufacturing process consistently produces API of the desired quality, meeting predetermined specifications and regulatory standards. This stage typically includes three phases: (a) process design, (b) process qualification, and (c) continued process verification.
Our Services
Choose Us
Our API process development strategy is constantly evolving to adapt to the changing business and regulatory environment. Regardless of the stage of your project, we will customize a process development solution that will allow you to move your project faster throughout the product development cycle.