Development Of A Non-Standard Protein Therapeutic

At Curia, we understand that no two development programs are alike. Advancing a biologic from pre-clinical research to GMP manufacturing demands a CDMO partner with flexibility and hands-on expertise.

Recently, our Hopkinton, MA facility supported a client developing a therapeutic protein for an endocrine disease. The molecule—an engineered native protein with a unique domain designed to enhance efficacy — was administered intramuscularly. This non-standard protein presented several challenges. The client needed rapid material generation for early PK studies, while also navigating regulatory concerns related to the use of a His-tag. A proof of concept with an affinity tag–free protein had to be established. In addition, Curia was tasked with developing a stable CHO cell line and implementing a scalable purification process to enable clinical advancement.

This project is just one example of Curia’s customized approach to biologics development. Read the full case study to see how we helped prepare this molecule for early-stage clinical trials.