Successful IND submissions require an intense coordinated effort to meet strict requirements while balancing speed to file. The processes involved in API development must continuously adapt to changes in regulations along with the unique traits of each API to achieve successful manufacturing strategies and IND approval. Even during beginning stages of API synthesis, the most successful design incorporates adjustments based on thorough analysis of each reaction step.
The starting point is often derived through medicinal chemistry and it may not be readily scalable, safe or meet regulatory standards for purity. Designing the best synthesis route for later success with IND submission must account for all impurities while aiming to reduce steps that are impractical for scale-up in terms of timing and cost.
Here, we follow this compound through a full cycle of IND development at Cambrex, from modifications to the synthetic route to formulation development and API manufacturing. Ultimately, more than 10 batches of drug substance (DS) and drug product (DP) including clinical trial material were released with 9 ICH stability studies set, all under one roof.
Across the organization, our teams meet challenges like those presented here with expert analysis and rapid problem solving to ensure your submission has the highest yield with a phase appropriate purity. Through our expert design process, we ensure quality that meets or exceeds requirements for IND submission.