Process-related impurities
- Document process-related residuals in final drug substance
- Evaluate clearance throughout purification steps
- Validate process and establish acceptance criteria
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Set up meetingDetailed host cell protein overview enables targeted elimination of impurities
Explore customer caseInnovative development of an orthogonal method for analysis of Host Cell Proteins
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The SWATH mass spectrometry technology is a data independent acquisition strategy used for e.g. residual protein and process related impurities analysis. This means that all MS/MS fragmentation data for every peptide in your sample is collected.
This is only possible due to the high speed of modern mass spectrometers.
The Sciex 6600 TripleTof instrument makes it possible to divide the whole mass range into sequential windows of size from 5-50 daltons. And it makes it easy to perform MS/MS fragmentation covering the full mass range (m/z 350-1700) within a few seconds. We set up the individual windows based on analysis of your samples, and typically get 50-100 windows.
In this way we therefore obtain MS/MS data for all peptides without having the instrument to select certain peptides for MS/MS fragmentation.
The MS/MS data set is linked to the retention time and can contain MS/MS data from multiple peptides. The extraction of these MS/MS data are done using a spectra library linking to peptide sequences in a library.
The spectra library can be prepared in many ways. The most simple way is to run a few samples in data dependent acquisition mode to collect good MS/MS data. Or it can be more advanced based on off-line fragmentation followed by MS/MS analysis of each fraction. We can extend the library with new MS/MS data at any given time, and use it for a research of old SWATH data.
HCP analysis using SWATH technology requires sample material in sufficient amounts to obtain good data. It is important to prepare samples in a clean laboratory to avoid contamination with human keratin.
Samples can be submitted in liquid or lyophilized.