09.13.25 -- Outsourced Pharma Best Of August

Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.

Decades of experience in cell and gene therapy outsourcing have taught Donna Rill, Chief Technology Officer, Triumvira Immunologics, that the key to success is ensuring CDMOs and sponsors understand the need to continuously align SOWs with the variances as projects move forward.

Recent shifts within the U.S. FDA reflect an increase in tension between scientific rigor and building political and economic pressures. Here are the newest developments and emerging focal points.

Novel technologies and therapies are helping drug developers to overcome challenges associated with the development of injectable and oral peptide formulations.

Emerging biotechs are behind many of the pharma industry’s latest therapeutic innovations. And while CDMOs are eager to work with them, they must learn to accommodate their unique needs.

Explore advanced approaches to designing robust amorphous formulations and optimizing spray drying processes tailored specifically to difficult-to-formulate compounds.