While fully autonomous bioprocessing is within reach, adoption remains gradual as manufacturers navigate challenges around data maturity, regulatory expectations, and operational readiness. As companies modernize, the focus is shifting toward building the digital and organizational foundations needed to enable more intelligent, scalable process control, particularly through c...

Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what ...

Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of Off Script, w...

Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, the...