Protein aggregation analysis
Characterization of protein aggregation is a specialty of the analytical services provided by Coriolis Pharma. Our expertise and capabilities are of course also applicable to other biopharmaceuticals, i.e. oligonucleotides, oligosaccharides, vaccines, etc..
Protein aggregates can be very heterogeneous in their size, ranging from few nanometers up to visible particles of > 100 μm.
As obvious from the figure each size class requires dedicated analytical techniques for a proper characterization.
Increasing attention is paid to aggregation of biopharmaceuticals by regulatory authorities and relevant industry guidelines (ICH Q6B) recommend monitoring of changes of the product as a result of manufacture and/or storage, including aggregate characterization.
The EMEA guideline on development, production, characterization and specifications for monoclonal antibodies and related products states: "Multimers and aggregates should also be appropriately characterized using a combination of methods. The formation of aggregates, subvisible and visible particulates in the drug product is important and should be investigated and closely monitored on batch release and during stability studies. In addition to the pharmacopoeial test for particulate matter, other orthogonal analytical methods may be necessary to determine levels and the nature of particulates."
At Coriolis Pharma we focus on the elemental question "What happens to my product and what are the most suitable methods to find out?". In order to address this, we have built up an unrivaled expertise over the recent years, as can be seen from numerous publications in the fields of analytical characterization of protein aggregation. Some of these publications have been awarded and are key literature for any scientist who is active in the aggregate and subvisible particle area.
Looking at our analytical portfolio for characterization of aggregates it becomes obvious that we are going beyond the classical HP-SEC and DLS analytics used to assess aggregation.
We understand that an orthogonal approach for analyzing aggregates is crucial to assure the optimum stability of a formulation. We offer the best techniques for each size range, with selected methods (AF4, HF5, HP-SEC, MFI and light obscuration) under cGMP including full qualification and validation of the instruments.
Also we provide a full range of forced degradation conditions prior to sample testing.