Production & Manufacturing

Building a compelling Series B case in biopharma goes well beyond efficacy data and market size projections. Sophisticated investors are increasingly focused on CMC risk, licensing obligations, and the defensibility of your manufacturing timeline. This article breaks down what the financial model behind a strong Series B actually looks like and what quietly kills deals that should have worked.

Ask any experienced biopharma program manager what derails an IND filing most often, and the answer is rarely surprising: it is CMC. Not insufficient efficacy data, not toxicology surprises CMC. This article examines why Chemistry, Manufacturing, and Controls continues to be the most underestimated risk in early drug development, and what program leaders can do about it.

Choosing a gene expression system is one of the earliest and most consequential manufacturing decisions a biotech founder will make yet it is often made without fully understanding what is at stake. This article breaks down the key expression platforms used in biologic drug development, what differentiates them technically and commercially, and why the choice you make now will follow your program all the way to the clinic and beyond.

AbbVie has outlined plans to build a major new manufacturing facility in Durham, committing $1.4 billion to what will become its largest single-campus capital investment to date. The project, spread across 185 acres, is expected to generate more than...

AbbVie has entered into a global licensing agreement with China-based Haisco Pharmaceutical valued at up to $715 million, aiming to strengthen its presence in pain therapeutics. The Haisco deal grants AbbVie exclusive rights to develop, manufacture, and commercialize multiple...

Danish pharmaceutical major Novo Nordisk has entered into a strategic collaboration with OpenAI to embed artificial intelligence across its drug development operations, with the stated goal of accelerating the delivery of new treatments. Announced on Tuesday, the initiative is...

The deployment of intelligent sensing technology is fundamentally reshaping how pharmaceutical manufacturers manage complex production environments. By providing granular, real-time data at critical control points, these advanced instruments allow for instantaneous process adjustments, ensuring that every batch meets the most rigorous standards of quality and safety.