Spectralys Biotech, a ULB spin-off in the start-up phase, offers innovative analytical solutions for therapeutic proteins based on a unique multiparametric method exploiting infrared spectroscopy (FTIR).
Through measurement, an infrared spectrum can provide a global and unique fingerprint of a sample. This sum of information has proven to be very accurate and sensitive to subtle changes, but should be interpreted in a way that maximizes the amount of information that can be retrieved. Over the past 10 years, our team has developed the expertise (patent pending), by a single measurement, to obtain information on 4 key parameters concerning the structure and quantification of proteins:
- higher order structure (absence of denaturation and aggregation);
- composition and quantification of post-translational modifications (glycosylations, oxidation, phosphorylations, etc.);
- overall protein concentration; and
- quantification of key excipients such as detergents (Tween, etc.), stabilizers, or lipids.
Depending on the specific situation, collecting this data today would require leveraging 3-4 distinct techniques and protocols. In addition, infrared spectroscopy makes it possible to analyze the structure and components of proteins precisely, quickly and directly (a few minutes), with a limited sample volume (<50µg) and without the need for extensive pretreatment or recurring calibration. Thanks to these attributes, the speed of measurement can be up to 3 to 10 times higher than with other techniques.
Given these strengths, our team has developed new analytical methods that are particularly relevant to study the stability of therapeutic proteins and to verify batch-to-batch consistency during processing as a PAT tool. Key applications of our technology include:
- accelerated stability testing for proteins in R&D phases,
- affordable comparability studies for early-stage biosimilar candidates, and
- multiparametric consistency testing from batch to batch of biopharmaceuticals in the production chain.
These methods can be transferred to the customer’s site, ensuring real-time on-site and in-process information on key characteristics of the therapeutic proteins produced. We would be happy to share more details on real-world applications in a short presentation, at your convenience.
