ATRS InstrumentProject ID: 674107
H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing
Gesamtkosten:EUR 71 429
EU-Beitrag:EUR 50 000
Koordiniert in:United Kingdom
Thema(en):NMP-25-2014-1 - Accelerating the uptake of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs
Aufruf zur Vorschlagseinreichung:H2020-SMEINST-1-2014See other projects for this call
Finanzierungsprogramm:SME-1 - SME instrument phase 1
The objective of the overall innovation project is to develop a novel instrument to measure and control pharmaceutical drug potency during manufacture at sub-second analysis speeds. This will significantly reduce the cost of quality testing, reduce the dosage variability that a patient receives, reduce production waste and solvent disposal and address challenging new regulatory testing guidelines.
Pharmaceutical companies, in response to regulators (such as the US FDA) setting direction and guidance, need to better understand and control their processes. Real-time release testing (RTRT) and Quality by Design (QbD) are promoted by regulators as their vision of where quality must go; pharmacopeia guidance supports that vision.
Cobalt has developed a successful, patented, high speed quantitative analysis technology called transmission Raman spectroscopy (TRS), which measures drug potency of intact tablets and capsules. When used during production (“on-line”) in combination with an automated physical tablet testing system, TRS will enable immediate release of drug product without “off-line” analysis in a quality control (QC) laboratory.
EU-Beitrag: EUR 50 000
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