November 19, 2020
Partnership between Spectralys Biotech and Quality Assistance
Spectralys Biotech is an analytical Contract Research Organisation (CRO) with scientific expertise in FTIR spectroscopy applied to biomolecules. Their FTIR spectroscopy services rank best-in-class and help solve complex challenges from structural characterisation and glycan analysis to in-process monitoring.
Quality Assistance is an analytical CRO with highly qualified scientists able to provide customised solutions, define analytical protocols, as well as develop, transfer and validate specific new analytical methods in accordance with EMA/FDA/ICH regulations and in compliance with the highest quality standards of the pharmaceutical sector (GMP, GLP, GCP/GCLP).
A fruitful collaboration is born: Quality Assistance adds up FTIR to its wide range of analytical techniques for biomolecules and Spectralys Biotech can ensure the transition of its services to GMP phases.
From supporting early stages of the development and non-clinical and clinical investigations to assessing the Quality, Safety and Efficacy of candidate drugs, together Spectralys Biotech and Quality Assistance bring solutions and expertise to respond to industry needs.
About Spectralys Biotech
Spectralys Biotech is a spin-off from the Université libre de Bruxelles. We are offering FTIR-based analytical services for the biopharmaceutical industry. Key applications of our expertise include structural characterization, stability studies, batch consistency check of proteins and antibodies and comparability studies of biosimilars.
Our highly skilled team provide cutting-edge services using our flexible dedicated software and a unique equipment (state-of-the-art spectrometers including high-throughput and imaging systems).
About Quality Assistance
Quality Assistance is a leading European CRO providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. In order to evaluate the Quality, Safety and Efficacy of the given drugs for each client project, we design customised solutions, define analytical protocols, as well as develop and validate specific new analytical methods. In addition, we perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies, and batch release testing. The Quality Assistance environment is GMP, GLP, GCLP/GCP compliant.