Overcoming Commercialization Challenges: Development Strategies

By Dr. Matthias Lucke, Group Leader Business Development

Successfully bringing a biopharmaceutical product to market requires overcoming a range of late‑stage development challenges. As drug candidates progress from early to advanced development, their value increases significantly, and generic platform approaches are no longer sufficient. Instead, activities must be adapted to the specific molecule. These essential tasks include final formulation adjustments, robustness testing, and validating scaled‑down models that support reliable process performance. Critical operations—such as pumping, filtration, mixing, filling, thawing, and freezing—must be thoroughly characterized to ensure they translate effectively to commercial scale.

Late‑stage programs also demand careful selection of primary and secondary packaging, detailed stability studies, forced‑degradation testing, and simulations of transportation and distribution conditions to confirm product resilience. Updating clinical‑use testing procedures, including how the product is prepared for administration, is equally important. Smaller or emerging companies often face barriers due to limited expertise and the high level of coordination required, prompting some to license their assets rather than manage commercialization internally.