Development of a Non-Standard Protein Therapeutic
At Curia, we know no two development projects look the same. Preparing a biologic to advance from pre-clinical research to GMP manufacturing requires a flexible and hands-on CDMO.
Curia recently helped a client with a therapeutic protein development project, one of many success stories at the Hopkinton, MA facility. Molecule X was an engineered native protein containing a specific domain to improve its efficacy. Developed for an endocrine disease, it was administered through the intramuscular route. Curia’s helped address multiple challenges with this non-standard protein. First, the client needed to generate material for early PK work quickly. That also required a solution around regulatory challenges with using a His-tag. A proof of concept with an affinity tagless protein would need to be confirmed. Finally, Curia needed to generate a CHO stable cell line and have a scalable purification process to proceed with clinical work.
Read the full case study to learn more about Curia’s approach to custom development and how it prepared this molecule for early-stage clinical trials.