WHO/UCAB Collaboration

WHO/UCAB program is the collaboration between UCAB (Utrecht Centre for Affordable Biotherapeutics for Public Health) and WHO. UCAB is responsible for the identification of technologies that will qualify for development. It will conduct landscape analyses for potential products in close collaboration with WHO. It will take up the development of the cell lines producing therapeutic proteins, either in-house or in collaboration with external partners. With WHO’s supervision, UCAB will ensure that products will be developed according to the highest possible quality standards.

UCAB oversees all phases of the development of biosimilar products, from the development of high-yield cell lines and production process development to coordinating the preclinical and clinical development program. UCAB standardizes manufacturing central data collection and shares the information with partners. By making use of the same producing clone and organizing centralized quality control, local manufacturers can refer to the central database to eliminate the need of repeating costly clinical studies. This will ensure that local manufacturer will be able to produce biotherapeutics in a timely and cost-effective manner and use the centrally generated data for their local marketing authorization application.

By sharing the costs of development between multiple local manufacturers, UCAB facilitates the development and sustainable production of high quality and affordable biotherapeutics for patients in low and middle-income countries (LMICs).