Lund University

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Selective and sensitive tools for bioprocess monitoring and control

Trace amounts of impurities are attracting a lot of interest today among pharmaceutical companies producing proteins/peptides for injection.
Earlier it was sufficient to state that the product was at least 99,85 % pure, but now questions are asked about the remaining 0.15%. Which compounds are there and how much of each? Is it possible to change the purification protocol in order to remove these traces? To answer this type of questions, a set of ultrasensitive biosensors are used. Monitoring of endotoxin, host cell proteins and ligands that have leached from affinity adsorbents used (e.g. protein A from purification of monoclonal antibodies) are examples on projects that are studied today. Furthermore, when producing recombinant proteins, there is always a risk that some of the target molecules get modified e.g. by proteo-lysis such that truncated proteins are mixed with the true target molecule. To monitor this is usually a tedious process, but a new technology developed in the department makes it possible to detect levels of truncated  proteins quick enough so that it will be possible to sample a fermentation and to harvest the valuable compound when the levels of truncated molecules start to rise.
Other projects of interest: ultrasensitive analyses of bacterial toxins using capacitive binding assays as well as flow injection analyses. Sol-gel encapsulation of biomolecules for the use in diagnostic kits.