Intertek’s primary capabilities include GLP bioanalysis and GLP or cGMP characterization for oligonucleotide therapeutics.
These include purity and impurity profiles by UPLC, HPLC, LC-MS, IEX-HPLC, CGE, NMR, detailed MS characterisation using MALDI MS, ESI-MS, CMS, LC-MSMS and 31P-NMR characterisation of APIs and product related P containing impurities. We also perform higher order and aggregation studies. We are adept at method development and validation and apply these methods can be applied to GMP compliant QC, stability and release testing. Our GLP laboratories typically apply a range of bioanalytical techniques including ELISA, mass spectrometry approaches (LC-MS/MS, and UPLC-MS/MS) and capillary gel electrophoresis (CGE).
Intertek support product development from QC testing of amidite starting materials and early stage product characterization through to GMP batch release testing.
Their extensive range of products and solutions include;
- cell-based potency testing
- physicochemical properties identity,
- internucleoside and sequence determination
- purity and identification of (product-related and process) impurities
You can explore a full range of Intertek products on the Intertek website here.
Intertek also supports;
- Asia TIDES
February 24-26, 2020
The Westin Miyako Kyoto, Kyoto, Japan
- TIDES Europe
12-15 November 2019
RAI Amsterdam, Amsterdam, Netherlands