Analysis of Biopharmaceuticals
16 articlesSpeedy 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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...