Enabling global access to high-quality biopharmaceuticals

•Economic models for drug development do not support transformative biomanufacturing.•Cost of goods for biologics are too high for promoting global access.•Increasing yields for fixed volumes and quality would lower costs of biologics.•Innovations in upstream and downstream processing, and analytics are needed.

Biologic drugs are an important class of therapeutics in the biopharmaceutical industry today. Manufacturing of these drugs is highly optimized to match the economic models in place for drug development in the developed world. To improve the accessibility of these therapies in low-resource to middle-resource countries, however, innovations in both the overall yields and quality/potency of drug product are needed. Advances in hosts used for expression, purification by non-conventional means, like crystallization, and new on-line analytics for process monitoring could help address these challenges. Ultimately, cost of goods should be reduced for biologics to a range where established global delivery mechanisms (e.g. public–private partnerships for vaccines) can become attractive alternatives.