Analysis of Biopharmaceuticals

18 articles

How to characterize antibody glycosylation by HILIC-MS

Question: What is N-glycosylation and how do I characterize the N-glycosylation of my antibody? Is it possible to compare batch-to-batch variations?   Answer: Glycosylation is...

Mar 4. 2019 | Thomas Kofoed |
1000 proteins quantified in e. coli mock lysate - HCP

Simple way to perform label-free quantification of Host Cell Proteins

Question: I find it difficult to get an accurate label-free quantification of Host Cell Proteins with LC-MS. It also seems that...

Jun 25. 2018 | Ejvind Mørtz |

What are ‘Jackpot HCPs’? Do I need a ‘lucky goat’ for precise ELISA results?

Question: I tested two different HCP ELISA kits on my biopharmaceutical. Why do they give different results and which one is...

May 28. 2018 | Anette Draborg |

Quickly compare HCP in different process steps, without an ELISA

Question: I have spent days trying to set up a useful ELISA assay for detecting Host Cell Proteins (HCPs) in my process samples. I'm...

Apr 10. 2018 | Ejvind Mørtz |
HPLC analysis of process related impurities by reverse phase mass spectrometry ( LC-MS analysis )

How to identify peaks observed by UV-HPLC in stability studies

Question: We have developed a Reversed-Phase (RP) UV- HPLC chromatography method. It is used for stability studies of our new pharmaceutical protein. How do we...

Jan 24. 2018 | Thomas Kofoed |
What is SWATH?

What is SWATH and why is it an advantage for Host Cell Protein analysis?

Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by mass spectrometry - for both identification and quantification of...

Jun 22. 2017 | Thomas Kofoed |

4 reasons why N-terminal sequencing should be done by Edman degradation

Question: How do I obtain the N-terminal sequences of the heavy chain and light chain of my monoclonal antibody?   Answer: mAb N-terminal sequence...

Apr 26. 2017 | Ejvind Mørtz |
Antibody characterization

Verifying Ile/Leu residues in de-novo sequencing of antibody

Question: I was told that de-novo sequencing by mass spectrometry is not able to distinguish between Ile and Leu residues in my...

Mar 22. 2017 | Fen Yang Reske-Nielsen |
Application note - mAb

What purity is required for de-novo sequencing of my antibody?

Question: My monoclonal antibody is not 100% pure, what is the purity required for de-novo sequencing?   Answer: We typically observe two types of protein impurities in...

Mar 20. 2017 | Fen Yang Reske-Nielsen |
100% sequence coverage map of antibody

Antibody de-novo Sequencing: How to get 100% sequence coverage

Question: Is it possible to perform a de-novo sequencing of my purified monoclonal antibody without the hybridoma cells?   Answer: Yes! – Your purified antibody can...

Mar 17. 2017 | Fen Yang Reske-Nielsen |

Why disulfide bridges are critical quality attributes of biologics

Question: The activity of my biopharmaceutical protein is low, and I suspect that it is related to decreased protein stability. What...

Mar 7. 2017 | Thomas Kofoed |

Why you need accurate concentration determination of protein standards

How do I quantify my protein standard? Have you ever questioned the quantitative data you get from Bradford, Lowry or BCA protein quantification...

Jan 18. 2017 | Thomas Kofoed |
Extinction coefficient protein concentration

Find the Molar Extinction Coefficient of your protein in 3 small steps

Question: I have a purified protein that I would like to quantify accurately in my lab using 280 nm UV measurement...

Nov 15. 2016 | Thanh Ha Nguyen |
Analysis method for Mw HCPs (small HCPs) below 20 kDa

Identification of small host cell proteins (low Mw HCPs)

Question: Could you suggest an analysis method to detect low Mw HCPs (small HCPs) below 20 kDa? I work on a drug...

Oct 11. 2016 | Ejvind Mørtz |
Protein scientist at Alphalyse

3 steps to identify & quantify HCP in drug substance homolog to host cell

Question: My HCP antibodies show a reaction towards a drug substance band in my Western blot. Is it possible that it is...

Sep 5. 2016 | Rikke Raaen Lund |

Identification of proteolytic degradation of recombinant protein

Question: I purified a recombinant protein and analyzed it by 1D SDS PAGE. In addition to the intact protein (52...

May 9. 2015 | Ejvind Mørtz |

Assessing stability of protein drug substance & formulated drug product

After protein purification, an important issue is the stability of a protein drug substance and formulated drug product. Stability assays...

Oct 21. 2013 | Ejvind Mørtz |

Host Cell Protein monitoring & control in process development

Mass spectrometry based Host Cell Protein identification and quantification Here the Mass Spec Host Cell Protein (HCP) assay is applied for...

Oct 2. 2009 | Ejvind Mørtz |
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