BioStaRT : Biopharmaceutical Stability at Room Temperature >>
Engineering and Physical Sciences Research Council (EPSRC) EHDA Network >>
EXTALcoat : External Tablet Lubrication Coating >>
Innovative Dynamic Medicines Development and Manufacturing Platform
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.
For more information contact Geoff Smith
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, Genzyme Ireland, Blue Frog Design and De Montfort University.For more information, please contact Geoff Smith.
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Engineering and Physical Sciences Research Council (EPSRC) EHDA Network
The EPSRC EHDA network brings together specialists from academia and industry to advance this technology platform through several means.
For more information see EHDA Network.
EXTALcoat : External Tablet Lubrication Coating
An Innovate UK funded collaborative R&D feasibility study (Feb 2018 to Jan 2019) with Micron Design, Merlin Powder Characterization, S3 Process, Nutrapharma Ltd and GEA Pharma Systems that will develop a novel process analytical technologies (PAT) for controlling the external lubrication coating of tablet tooling in the manufacture of pharmaceutical tablets. The advantages of external lubrication over conventional internal lubrication (lubricant blend inside the tablet formulation) are improved mechanical strength, reduction in defects (capping and sticking) and shorter disintegration times. However, poor coating control with external lubrication systems present validation issues and regulatory barriers. The project will demonstrate industrial feasibility for PAT controlled external lubrication coating in the manufacture of orally disintegrating tablets, i.e. those prepared by direct compression technology and intended to disintegrate in the mouth within 3 minutes, while enabling extended run times in continuous direct compression manufacturing technologies, increasing process efficiency of continuous direct compression tablet manufacturing, accelerating R&D and shortening time to market, and increasing the profitability of the sector.
For more information contact Geoff Smith.
De Montfort University has created a unique Centre for Rapid Medicines Development in a Quality by Design framework on an adaptive Continuous Manufacturing platform. The Centre offers unique, hands-on experience in areas such as formulation, process analytical technologies (PAT) and quality risk management.
For more information contact Walkiria Schlindwein
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