Summary
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.
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.
Unfold all
/
Fold all
More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/674107 |
| Start date: | 01-04-2015 |
| End date: | 30-09-2015 |
| Total budget - Public funding: | 71 429,00 Euro - 50 000,00 Euro |
Cordis data
Original description
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.
Status
CLOSEDCall topic
NMP-25-2014-1Update Date
27-10-2022
Images
No images available.
Geographical location(s)
Structured mapping
Unfold all
/
Fold all
H2020-EU.2.1.2. INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies
