In the past, product characterization was simple and standardized. Developers of small molecule pharmaceuticals performed a battery of tests around Phase II or III clinical trials, fulfilled the ...

Microbial systems offer distinct advantages in protein expression, saving costs and time, and offering well-characterized host genetics and ease of scale-up. 2 However, challenges remain in process ...

Process validation, including process characterization, is a critical step in the successful commercialization of a new biopharmaceutical on its path to commercialization. As the program approaches ...

As biologics programs progress toward commercialization, late-stage development introduces distinct challenges—from scaling processes efficiently to ensuring regulatory readiness and maintaining cost ...