The early stages of formulation development and analytical testing can be some of the most exciting phases of drug development, fueled by the anticipation that follows the discovery of a promising new active pharmaceutical ingredient (API) or combination. So how can companies ensure success at this stage when working with contract development and manufacturing organizations (CDMO)?
Episode 1 – Formulation: Moving from molecule to clinic
In the first episode, Devin Corson, Senior Formulation Scientist at Sharp Clinical joins series host Steve Jacobs to share her learnings on small molecule formulation development, scale-up, and how best to collaborate with your CDMO to bring your new molecule out of the lab and into the clinic.
Listen to episode one below:
While the excitement to commence clinical trials often motivates tight deadlines in R&D, sufficient time is critical for understanding and optimizing an API’s bioavailability, stability, toxicology, and excipient compatibility. With many years of experience, Sharp’s scientists have overcome countless formulation-specific obstacles in both small and large molecule drugs.
“When we’re working with an active pharmaceutical ingredient, there’s so much that is unknown,” says Devin Corson, Senior Formulation Scientist at Sharp Clinical. “We really have no idea how it’s going to affect different parts of the body and how it’s going to interact with different excipients.”
This podcast is the first instalment in a series by Sharp, titled Our experience is your strength. Across the episodes, host Steve Jacobs is joined by seasoned experts in formulation, sterile manufacturing, clinical supplies, commercial packaging, and sustainability to explore a range of challenges across drug development and commercialization, with a focus on getting the best results through contract services. Each episode draws upon key learnings gathered across Sharp’s decades of experience as a CDMO, helping to set listeners up for success with their chosen vendor.
