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 ...

Lyophilization, or freeze-drying, is essential in biopharmaceutical production but presents significant challenges, such as long timelines, high prices, and ...

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

Single-use technologies (SUT) are well-suited for modular production environments and represent a valuable solution in today’s ever-evolving biologics development landscape. Though SUTs have been ...