API Drug Substance Development

Active pharmaceutical ingredients (APIs) are the core active component in a pharmaceutical product. Without APIs, there is no small molecule drug. API development occurs early in the drug development process, through steps that include discovery, synthesis, characterization, and scaling-up of chemical substances. Establishing an efficient and reliable process at this stage is critical, as APIs will remain central to the pharmaceutical manufacturing process for the full lifecycle of the drug.

Continuous flow processing is a more environmentally friendly, highly efficient, and cost-effective alternative to traditional batch processing. In addition to these advantages, it can achieve low-temperature reactions, hazardous reactions (e.g., azide reactions, hydrogen peroxide, etc.), high pressure (300 ATM), high temperature (600° C), and catalytic reactions.

New partnerships always begin with technology transfer. We’ve done this many, many times before. Our teams are adept at transferring, validating, and registering methods and processes. Next comes process development, which includes many important steps for the design, optimization, and validation of your small molecule. We’ll also be sourcing your raw materials and establishing a robust supply chain. As your program progresses, we can begin CGMP small-scale manufacturing, increasing batch volumes and the sophistication of our analytical offerings as your program advances towards commercialization.

We understand speed and efficiency are crucial in the competitive (and expensive) world of pharmaceutical development. This must be achieved without compromising safety or long-term viability. For us, the solution is two-fold. The first is our investment in innovative technologies and techniques that allow us to handle high-complexity projects and optimize API manufacturing at every production scale. The second is our commitment to collaboration and partnership. Our integrated team works cohesively with each other and with you to continually align with your project needs.