Flow-inova: Innovation in manufacturing medicines

Lead Participant: Arc Trinova Limited

Abstract

The nature of small molecule drug substance manufacturing demand is changing in response to the development of new and more targeted pharmaceutical treatments. Small molecule drug substances are becoming generally more complex in nature, more potent, and as a consequence the drug substance requirements for a candidate drug, both through the clinical development phase, and at commercial launch, has reduced significantly. The future emphasis for drug substance manufacture will be on new manufacturing technologies which can be can be introduced to handle increasing complex chemistries, where manufacturing inventories need to be kept low, where product purity needs to be maximized, where manufacturing throughput and efficiency are maintained at high level, where the technology can be aligned with the ethical and economic desire to minimize reagent, catalyst, and solvent usage as part of a GREEN and where the manufacturing technologies can be rapidly switched over to cope with low batch numbers, but increasing numbers of discreet manufacturing stages. There is therefore a clear, and as yet unmet need, for the implementation of a flexible modular manufacturing technology platform which can facilitate the above. Our vision for this project is the development of a continuous, modular manufacturing technology platform which will enable ARCINOVA to be a leading player in the development, scaleup and manufacture of new small molecule drugs. The project will focus on the development of new innovative continuous manufacturing technologies which can be rapidly transferred from proof of concept to a commercial scale asset. Initially a number of key technology areas will be chosen for development. These areas will be chosen on the basis of expected technical need from ARCINOVA, and on the basis of demonstrated expertise from the academic partner (University of Nottingham). The project outcome will enable the consortium to demonstrate operating feasibility of world first innovative continuous production tools, and will establish ARCINOVA as a world leader in defining continuous modular manufacturing technology for the support of new chemical entities (NCEs) development, scale up and manufacture

Lead Participant

Project Cost

Grant Offer

Arc Trinova Limited, Alnwick £1,233,330 £ 739,998
 

Participant

University of Nottingham £699,931 £ 699,931

Publications

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