Post by Lonza

Complex biologics like bispecifics, ADCs, and fusion proteins are reshaping treatment pipelines, raising the bar for what’s possible. But greater molecular complexity also means greater development risk, especially when manufacturability or immunogenicity challenges surface too late.   For small and emerging biotechs, the pressure is real: move fast and stay investor-ready without compromising IND readiness, or derailing the program entirely.   In this BIO-Europe Spring Supplement, Megan Mason and Alice Harrison outline the key areas where early decisions make the most significant difference:    - Spotting sequence and developability risks before committing to the wrong path  - Designing formulation strategies that reflect the reality for more complex molecule formats  - Generating tox material early enough to stay on track  - Building a strategic CMC plan that supports IND readiness from day one   Done right, these early choices shape everything that follows.   Read the article to see how we approach it.   #Biologics #BiologicsDevelopment #CMC #INDReadiness #Biotech #CDMO #DrugDevelopment