Bioprocess optimization

  • Evaluate clearance of individual HCPs between purification steps
  • Compare HCP profiles for tech-transfer batches between CMOs
  • Monitor HCP content during process changes and scale-up

Do you want to improve and speed up your process development?

We can identify Host Cell Proteins (HCPs) in your process samples by LC-MS analysis. The analysis provides the identity and quantity of each individual HCP, in addition to the total HCP content (ng HCP/mg drug substance).

The results can be used for intelligent optimization of down-stream purification to remove process related impurities and bri...

Do you want to improve and speed up your process development?

We can identify Host Cell Proteins (HCPs) in your process samples by LC-MS analysis. The analysis provides the identity and quantity of each individual HCP, in addition to the total HCP content (ng HCP/mg drug substance).

The results can be used for intelligent optimization of down-stream purification to remove process related impurities and bring down HCP levels.

For bioprocess samples, we offer an optimized workflow providing reproducible HCP identification and quantification.

The standard analysis includes

  • A generic sample preparation for process samples in different matrices
  • LC-MS peptide analysis on a robust microflow HPLC and Sciex TrippleTOF 6600 mass spectrometer using SWATH LC-MS for reproducible HCP identification and quantification
  • Report with a list of HCPs and their physiochemical properties (MW, pI, AA sequence, database accession number) for each process sample

Send us a description of your project and we will be glad to discuss Host Cell Protein analysis with you.

MoreLess details

The process:

  • 1 Contact us to discuss your project and receive a project proposal
  • 2 Analysis phase lead by Alphalyse appointed principal investigator
  • 3 Report listing individual HCPs with physio-chemical properties - for each process step
  • 4 Follow up by phone or email

Start the collaboration

We offer customized solutions, contact us to discuss your project.

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Send us a description of your project and we shall be happy to present you with a solution.





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Testimonials

  • "Alphalyse´s HCP analysis saved us the development of an ELISA assay that may not have worked anyway."

    Innovative development of an orthogonal method for Host Cell Protein analysis

    See more
  • "The most sensitive, yet robust, Host Cell Protein analysis we’ve seen"

    Analyses of key protein features, stability and impurity levels

    See more

Knowledge center

More information

We would like to help you as much as possible with your project and therefore provide several kinds of customer support:

Technical details

What is SWATH?

The SWATH mass spec technology is a data independent acquisition strategy. 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  still being able 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 can obtain MS/MS data for all peptides without having the instrument to select certain peptides for MS/MS fragmentation.

Table of HCPs in different process step samples

Table of HCPs in different process step samples

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. The library can be extended with new MS/MS data at any given time, and used for a research of old SWATH data.

8 selected HCPs through the 6 process steps

8 selected HCPs through the 6 process steps

Sample preparation

Sample requirements for SWATH LC-MS/MS

HCP analysis using SWATH technology requires sample material in sufficient amounts to obtain good data. It is important that samples are prepared in a clean laboratory to avoid contamination with human keratin.

Samples can be submitted in liquid or lyophilized.

Samples for Library generation and SWATH analysis

  1. The analysis requires typically a minimum of 500-1000 μg of protein material for each sample
  2. The samples should not contain large amounts of detergents
  3. The concentration should be >0.5 µg/µl
  4. Use a Eppendorf Safe Lock tube supplied, or similar tubes from your lab
  5. Freeze or refrigerate to +4 oC for cold shipment of the liquid sample
Related services

Meet the experts

For this type of analysis our experts include:

Do you need help?
Rikke Raaen Lund

PhD in Biomedicine

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Do you need help?
Janne Skaarup Crawford

BSc in Cell Biology and Biochemistry

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Do you need help?
Inga Boll

MSc in Biochemistry & Molecular Biology

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