- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Transmission Raman method gains regulatory approval for content uniformity batch release test
25 November 2014 • Author: Cobalt Light Systems
Cobalt Light Systems is pleased to announce that a major pharmaceutical company has gained regulatory approval to release products using Cobalt’s TRS100 instrument instead of by HPLC. This is a landmark achievement in reducing the industry’s dependence on the expensive and time-consuming “workhorse” technique of High Pressure Liquid Chromatography (HPLC). The content uniformity (CU) test assesses whether all of the tablets in a manufactured batch contain the right amount of active ingredient, so is a crucial regulated test for determining product safety.
HPLC is the industry’s “go-to” technique for CU testing, but it has significant disadvantages. As well as taking hours per test it requires a trained chemist, solvents and other consumables, a sample preparation step and is limited by the throughput of a quality control laboratory. Typically, only 10 tablets from a batch of perhaps millions of tablets are tested – for larger sample sizes the time taken would be prohibitive by HPLC. The TRS100 can test 100-200 tablets or capsules in one measurement run in 20-40 minutes – an HPLC equivalent might take several days to complete that many, at a significantly high cost. The TRS100 performs a complete CU test in a few minutes – less than 10 seconds per tablet or capsule – saving typically around $500 per batch test.
Transmission Raman spectroscopy has many advantages and is under evaluation at many pharmaceutical companies as a means to improve quality and reduce costs. The HPLC market for pharmaceutical companies is worth approximately $1.1Bn, of which 60% is the cost of consumables, such as solvents and columns. By removing the ongoing costs, skill requirements and operator variability of HPLC, transmission Raman can significantly increase the throughput and quality of a QC laboratory. Cobalt’s Business Development Director, Darren Andrews, said, “Transmission Raman is a fantastic fit for this application and gaining regulatory approval to use it as an alternative to HPLC removes a perceived barrier to the industry’s more wide-spread adoption. I expect significant growth for TRS in this area as more approvals are expected soon.”
An upcoming live webinar on the 10th December will discuss the approach to achieving successful registration and interpretation of current regulatory guidance. See website for details http://www.cobaltlight.com/members/webinars/442.
To enquire about the TRS100 instrument or capabilities contact Cobalt Light Systems firstname.lastname@example.org or +44 1235 856 555. Alternatively, contact your local representative http://www.cobaltlight.com/distribution/116.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics