BioAccord – Nitrosamines and more

In response to the increasing demand for large molecule analyses, we at Chromicent are currently testing the BioAccord system from Waters. The background and further information on the BioAccord can be found *here*.

In the past few months, we have been working intensively on various issues. Here is a brief overview of the most exciting projects so far:

  • Peaktracking of impurities in method development of natural and synthetic peptides
  • Sequence analysis of natural and synthetic peptides
  • Digestion (proteolytic degradation) and subsequent sequence analysis of proteins
  • Analysis of antibodies and antibody mixtures with regard to their isoforms
  • Glycan analysis
  • Oligonucleotide analysis

Team Chromicent in action – preparing for a demo of the Waters BioAccord LC-HRMS System.

Especially interesting, however, is our project on nitrosamines in biologics or nitrosaminated biologics.

The background: Nitrosamines are an important field of work for Chromicent. You can find more about this *here*, *here* and *here*.

Our publication analysing nitrosamines by SFC-MS/MS was acknowledged by the EMA as an alternative approach. The follow-up publication has been submitted to the renowned Journal of Biomedical and Pharmaceutical Analysis and has been accepted. In its final assessment report, the EMA currently refers to the problem of nitrosamines in biologics and nitrosaminated biologics.

Although the overall risk of presence of nitrosamines in biological medicinal products is considered very low, the following risk factors should be taken into consideration: biologicals containing chemically synthesized fragments, where risk factors similar to chemically synthesized active substances are present, biologicals using processes where nitrosating reagents are deliberately added, or those packaged in certain primary packaging material, such as blister packs containing nitrocellulose.

EMA, Assessment report, S.78

Chromicent is taking a completely new approach here with the use of BioAccord for method development – but initial results are certainly positive. We will keep up to date.

If you have any questions or are interested in this topic or the other topics – Please contact us.

At this point we would also like to mention our offer once again:

Until the end of March we still offer the possibility of free test measurements or demonstrations of the BioAccord system. If you have samples, analytical challenges or are generally interested – Contact us. Try out high-end analytics with us. Go one step further with us.