See how BioDlink’s digital-intelligence platform is driving three major improvements in lyophilization workflows.

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 ...

Globally Harmonized Regulatory Approach Is Needed to Move Forward Expeditiously The concept of well-characterized biologicals originated with the FDA Center for Biologics Evaluation and Research (CBER ...

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 ...