ATRS InstrumentProject reference: 674107
Funded under :
H2020-EU.2.3.1. - Mainstreaming SME support, especially through a dedicated instrument
Real time analysis of tablet and capsule dosage during pharmaceutical manufacturing
Total cost:EUR 71 429
EU contribution:EUR 50 000
Coordinated in:United Kingdom
Topic(s):NMP-25-2014-1 - Accelerating the uptake of nanotechnologies, advanced materials or advanced manufacturing and processing technologies by SMEs
Call for proposal:H2020-SMEINST-1-2014See other projects for this call
Funding scheme: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 contribution: EUR 50 000
BROOK DRIVE 174 MILTON PARK
OX14 4SD ABINGDON OXFORDSHIRE