Opportunities include the rising demand for innovative biologics and the increased need for diverse cell lines, including ...

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 ...

Over the last 20 years, automated capillary electrophoresis (CE) has become an industry-preferred technique for quantitative purity and heterogeneity characterization of a variety of biotherapeutics, ...

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 ...