Project description
New tool could revolutionise the development of medicine
Ensuring a consistent supply of high-quality active pharmaceutical ingredients (APIs) is the cornerstone of the pharmaceutical industry. High-quality APIs require consistent physical and chemical properties from batch to batch. These properties directly influence both the quality and safety of the final drug product and are therefore critical to efficacious patient therapy. Around 80 % of the world's APIs are dependent on crystallisation, which is a complex process that requires continuous monitoring to reach optimal quality with minimal waste. To address these challenges, the EU-funded SmartCrys project is supporting Innopharma Labs Limited in developing a fully vertically integrated manufacturing intelligence platform for crystallisation unit operations. The SmartCrys analyser suite is integrated with data storage and analytics capabilities to enable real-time remote monitoring and process automation control.
Objective
The project aims to address key challenges of the pharmaceutical industry related to the consistent supply of active pharmaceutical ingredients (APIs) which are formed through crystallisation processes. Over 80% of the worlds API’s have crystallisation steps. The current method of determining process performance is a combination of off-line analysis of the quality attributes of the API crystals after the crystallisation process is complete. This methodology does not control the manufacturing process and leads to a variable quality product, variable yields and a large proportion of rework batches, costing the API industry in excess of €10B/year. SmartCrys is an integrated solution for API processing issues of (1) in-line PAT Analysers to measure the critical quality attributes of the crystals, (2) Manufacturing Intelligence to interpret the data and decide whether process adjustments are required, (3) Process Automation which enable the automatic adjustment of the process to take place and (4) Data Analytics which enable visibility of all process data in real-time. SmartCrys enables rapid process development and subsequently self-adjustment of crystallization processes in real time, targeting an addressable market for SmartCrys of €20B. Through engagement with its customer base (8 of the top 10 Pharma companies worldwide) and the regulators, Innopharma have identified a technological gap in in-line process control among API manufacturers. SmartCrys will consolidate Innopharma’s position as one of the world’s leaders in Advanced Analytical Technologies within the pharmaceutical sector, and provide an opportunity to increase company turnover from €8M to €23M over the next 5 years and to grow staff from 45 to 65. It will also contribute to the continued competitiveness of the European API crystallization sector and help retain thousands of high-tech API manufacturing jobs within Europe.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- engineering and technology mechanical engineering manufacturing engineering
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- natural sciences earth and related environmental sciences geology mineralogy crystallography
- social sciences sociology industrial relations automation
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
MAIN PROGRAMME
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H2020-EU.3. - PRIORITY 'Societal challenges
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H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
SME-2 - SME instrument phase 2
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) H2020-EIC-SMEInst-2018-2020
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
Y14 REDCROSS
Ireland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.