Development and formulation centre for next generation biologics
|Coordinator||RISE Research Institutes of Sweden AB - Biovetenskap och material, STOCKHOLM|
|Funding from Vinnova||SEK 32 000 000|
|Project duration||January 2020 - December 2023|
|Venture||Centrum biologiska läkemedel|
Purpose and goal
The long term goal of NextBioForm is to create an internationally leading center for the development and formulation of biological drugs. The aim of the center is to build a platform to provide new formulations and new methodologies to improve patient and healthcare products, increase product stability of biological drugs, develop new excipients and formulation platforms, as well as develop quality-by-design (QbD) based drug development throughout the innovation chain.
Expected results and effects
NextBioForm will in the long-term lead to improvements for patients, industry and society through new methods, products and services. The center will establish a sustainable knowledge and competence base for formulation and development of biological drugs, and thus strengthen the Life Science sector in Sweden as well as internationally. During the 4-year period, new methods and knowledge regarding characterization, formulation, process opportunities will be generated that are made available to partners and actors inside and outside the center. A hub will set up for this purpose.
Planned approach and implementation
The project has 4 technical work packages with active participation by all partners. We develop knowledge and methodology for liquid and solid formulations, new formulation platforms, and use of large-scale infrastructures such as MAXIV. Other work packages support with QbD and regulatory expertise, communication, IP management and innovation development. A hub for the dissemination of knowledge and services is being developed. We internationalize the center through an advisory group with international participation from universities, industry, healthcare and patients.