As biologics grow more complex, early identification and the mitigation of manufacturability, stability and immunogenicity risks have become the critical factor separating programmes that reach IND on time from those that do not.
In this article, Yvette Stallwood, Head of Early Development Services at Lonza, explains why early de-risking is now a strategic imperative for biotech companies developing increasingly complex biologics, particularly advanced formats such as bispecifics, antibody-drug conjugates and fusion proteins. The article outlines how proactive developability assessment, in silico screening, expression system selection, construct optimization and integrated CDMO collaboration can support smarter candidate selection, help optimize lead molecules and identify potential barriers before they disrupt development timelines.
For biotech companies working under pressure from funding milestones, investor expectations and partnership timelines, the article highlights the value of early de-risking in helping reduce costly rework, supporting regulatory readiness, protecting program momentum and strengthening confidence in a clear, credible path to IND submission.
This article was originally published in Manufacturing Chemist, June Issue 2026, and is reproduced with permission.
