Project description
Engineering design processes for more effective drugs
Crystallisation processes are essential in pharmaceutical technology and drug manufacturing. Good crystallisation is important to achieve the desired yield as well as the purity, polymorphism, chirality and also the particle size and shape that strongly impact a drug product’s performance. Today, the pharmaceutical industry must respond to unprecedented pressures and upgrade its technological processes. Unfortunately, the currently used pharmaceutical quality by design model requires an enormous amount of testing. To overcome this burden, the EU-funded PharmaCrystEng project will develop innovative rapid design methods for the separation of enantiomers by crystallisation. Process analytical technology-based feedback and feedforward control techniques will be applied, ensuring fast experimental design. Project-advanced multi-population balance models will also improve further upscaling and optimisation.
Objective
Pharmaceutical industries face continuous challenges in terms of process development for new drug substances and product. Considerable amount of time and resources, both human and material, are spent on the engineering research, including the process, scale-up and control development for the promising molecules synthesized often in micro-gram scale firstly. Crystallization is a particularly important in the pharmaceutical industry as it links the drug substance (active pharmaceutical ingredient) and drug product (e.g. tablets, injectables etc.) manufacturing. Good operation of crystallization is not only important to achieve the desired yield, but the purity, polymorphism, chirality and also the particle size and shape strongly impact the performance of the drug product, e.g. the bioavailability, dissolution rate and, not rarely, the toxicity. Crystallization processes are currently being designed in pure experimental fashion, relying on the pharmaceutical Quality by Design (QbD), which undoubtedly moved and moves the pharmaceutical industry forward, but it has tremendous experimental burden. The digital era paws the way for competitive and often complementary computer aided process design techniques. The goal of this project is the development of novel process systems engineering methods that are suitable for rapid and robust-optimal crystallization process design. For experimental and simulation demonstration, to keep the simplicity without loss of generality, a challenging but frequently occurring pharmaceutical crystallization process will be considered: the preferential crystallization of enantiomers. For rapid experimental design, process analytical technology based feedback and feedforward control techniques will be developed as a direct alternative for QbD strategies. Multi-population balance models will be developed and applied for optimizing digital design as well as for scale-up and potential batch-to-continuous process transition analyses.
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 materials engineering crystals
- medical and health sciences basic medicine pharmacology and pharmacy pharmaceutical drugs
- natural sciences earth and related environmental sciences geology mineralogy crystallography
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
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.1.3. - EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions
MAIN PROGRAMME
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H2020-EU.1.3.2. - Nurturing excellence by means of cross-border and cross-sector mobility
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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.
MSCA-IF - Marie Skłodowska-Curie Individual Fellowships (IF)
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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-MSCA-IF-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.
1111 BUDAPEST
Hungary
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.