Analysis of Biopharmaceuticals
15 articles
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? Answer: For several years, monoclonal antibodies...
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...
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 method. It is used for stability studies of our new pharmaceutical protein. How do we...
What is SWATH & why is it an advantage in Host Cell Protein analysis?
Host Cell Proteins (HCPs) in protein biopharmaceuticals can be analyzed by mass spectrometry - for both identification and quantification of...
4 reasons for performing N-terminal sequencing 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...
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...
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...
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...
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...
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...
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...
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...