ATLASbio : Analytical Technologies for the Lyophilization of Biopharmaceuticals

The AtlasBio project (Feb 2017 to Jan 2020) is an Innovate UK funded RD project that will strengthen the UK knowledge base in science and engineering in the areas of freeze-drying product and process development, and influence the future directions and strategy in biopharmaceutical product and freeze-drying process development. The need is for new measurement technology for concurrent product and process design and the development of more efficient continuous processes, moving away from batch and increasing process efficiency and reducing waste. The project aims to develop and demonstrate scalable PAT to support freeze drying of biologics in order to support (i) scale up of batch freeze-drying (from high-throughput formulation screening to process development and scale-up), (ii) development of freeze drying processes for next generation biopharma products, by designing more robust, scalable processes via the in situ evaluation of interactions between critical material attributes and critical process parameters, thereby enabling (a) drying efficiencies (drying rate), and (b) the development and implementation of continuous freeze-drying methods. Partners are GEA Process Engineering, the National Institute for Biological Standards and Control, Blue Frog Design Ltd, IS Instruments Ltd, Ocean Optics UK, OncoLytika Ltd, Nottingham University, and De Montfort University.



BioStaRT : Biopharmaceutical Stability at Room Temperature

An Innovate UK funded collaborative R&D project (2014-2017) aimed at developing new analytical technologies to assist in the development of room temperature stable freeze-dried biopharmaceuticals. Partners include GEA Process Engineering, National Institute for Biological Standards and Control, Sanofi Ireland, Blue Frog Design and De Montfort University.