Analysis of Biopharmaceuticals

16 articles

Speedy and detailed protein ID of SDS gel bands

Question: The biopharmaceutical company that I work for, consistently uses SDS PAGE and Western Blotting to check protein expression. But this...

Jun 9. 2020 | Thomas Kofoed |
mAb analysis by peptide mapping

Assessing and monitoring the quality of therapeutic mAb products

Question: I need to ensure the quality and consistency of my mAbs. Which analyses should be conducted for proper mAb characterization? Answer: For...

Nov 25. 2019 | Thomas Kofoed |

Follow levels of process-related residual protein in purification

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...

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 |

How do ‘Jackpot HCPs’ and a ‘Lucky Goat’ influence my 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 |
UV-HPLC data analysis

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

Question:   We have developed a Reversed-Phase (RP) UV-HPLC chromatography data analysis method. It is used for stability studies of our new...

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

What is SWATH & why is it an advantage in Host Cell Protein analysis?

Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by the mass spectrometry SWATH analysis - for both identification...

Jun 22. 2017 | Thomas Kofoed |

4 reasons to perform N-terminal protein sequence analysis by Edman

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

Apr 26. 2017 | Ejvind Mørtz |
De-novo sequencing mAb

What purity is required for mAb sequencing by de novo?

Question: My monoclonal antibody is not 100% pure, what is the purity required for mAb sequencing with the de-novo method?   Answer: We typically...

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

De-novo Sequencing: How to get 100% antibody sequence coverage

Question: Is it possible to perform a de-novo sequencing of my purified monoclonal antibody without the hybridoma cells? Will I get 100% antibody...

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. Could...

Mar 7. 2017 | Thomas Kofoed |

Why you need accurate concentration determination of protein standards

Question: How do I quantify my protein standard? Is it true that it if it is done incorrectly it can affect...

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

Determine Molar Extinction Coefficient of your protein – 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 (small Mw HCPs)

Question: I work on a drug substance protein with a mass of 15 kDa. I would expect small host cell protein...

Oct 11. 2016 | Ejvind Mørtz |

Host Cell Protein monitoring in process development – using mass spec

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 |
Newsletter Subscribe to The Alphalyse Newsletter and get more
information on protein analysis methods and applications
© 2020 Alphalyse, Inc.