Analysis of Biopharmaceuticals

15 articles

How to document removal of process-related residual proteins through all purification steps

Question:   My company develops and produces a biologic. Recently, regulatory authorities asked us to document how efficiently downstream purification reduces the...

Sep 25. 2019 | Ejvind Mørtz |

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 my...

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 |
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 |
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

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

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 |

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 kDa),...

May 9. 2015 | Ejvind Mørtz |

Host Cell Protein monitoring & control in process development

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

Oct 2. 2009 | Ejvind Mørtz |
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