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Assessing and monitoring the quality of therapeutic mAb products
Question: Which analyses should be part of mAb characterization? I need to ensure the quality and consistency of my mAbs. Do you have any advice on which analyses I should conduct for proper mAb characterization? Answer: For several years, monoclonal antibodies (mAbs) have been the fastest-growing type of pharmaceutical molecules [1]: More than half of […]
Latest in: Analysis of Host Cell Protein See all
Quantifying HCP impurities in uncommon expression systems
Question: We use a plant-based expression system to produce our immunotherapy-based biologics. Unfortunately, since the expression system is quite unusual, commercial
How to select an HCP ELISA with sufficient coverage for regulatory documentation
Question: How do I choose the best ELISA kit for my biologic? In other words, I would like to select the impurity assay with the highest coverage of the process HCPs, not only for harvest samples but also for the HCP impurities in the purified drug substance. Answer: Host Cell Protein (HCP) analysis is essential in development and regulatory documentation of biologics. Since specific
Critical reasons why mAbs call for orthogonal HCP analysis techniques
Question: We produce a monoclonal antibody (mAb) product, and our HCP ELISA shows low ppm levels. Recently, I heard that regulatory
Latest in: Analysis of Biopharmaceuticals See all
Speedy and detailed protein ID of SDS gel bands
Question: Can I identify hundreds of gel bands in a few days? The biopharmaceutical company I work for consistently uses SDS PAGE and Western Blotting to check protein expression. But this means we spend a great deal of money on antibodies, which I feel may be unnecessary. In addition, we would like to identify several unknown proteins in the gels, possibly degradation
Assessing and monitoring the quality of therapeutic mAb products
Question: Which analyses should be part of mAb characterization? I need to ensure the quality and consistency of my mAbs. Do you
Simple way to perform label-free quantification of Host Cell Proteins
Question: How can I improve label-free quantification of HCP? I find it difficult to get an accurate label-free quantification of Host Cell
Latest in: Analysis of Amino Acid in protein See all
Why you need accurate concentration determination of protein standards
Question: How do I quantify my protein standard? How do I quantify my protein standard? Is it true that if done incorrectly,
Determine the Molar Extinction Coefficient of protein in 3 small steps
Question: How do I determine the molar extinction coefficient of my protein? I have a purified protein that I would like to
4 things to remember about Amino Acid Analysis of proteins & peptides
Why perform Amino Acid Analysis? Amino acid analysis of proteins is a method to determine the absolute amounts of individual amino
Latest in: 1D & 2D Electrophoresis See all
Speedy and detailed protein ID of SDS gel bands
Question: Can I identify hundreds of gel bands in a few days? The biopharmaceutical company I work for consistently uses SDS PAGE and Western Blotting to check protein expression. But this means we spend a great deal of money on antibodies, which I feel may be unnecessary. In addition, we would like to identify several unknown proteins in the gels, possibly degradation
1D SDS PAGE versus 2D PAGE. Any recommendations?
Question: Should I use 1D or 2D SDS PAGE? I'm interested in isolating and identifying cell surface receptor proteins. In my experience, they
How much protein should I load for protein identification by mass spec
Question: How should I prepare my samples for 2D electrophoresis? How should I prepare my samples for 2D electrophoresis, and how much protein should I load to get protein ID by the mass spec? Answer: First, it is essential to know that protein samples for 2D PAGE should not contain high salt concentrations, ionic detergents like SDS, or cellular debris and DNA from cell
Latest in: Bioinformatics See all
GPMAW lite – Protein Sequence Calculator (and much more)
When working with proteins, you often need to make simple bioinformatics calculations on a specific protein sequence - and for
Useful Protein Molecular Weight Calculator – kDa to pmol/µg
Protein molecular weight calculator kDa How do you quickly convert protein size measured in kDa or microgram into picomole - and
Latest in: Database Searching & Protein Identification See all
Speedy and detailed protein ID of SDS gel bands
Question: Can I identify hundreds of gel bands in a few days? The biopharmaceutical company I work for consistently uses SDS PAGE and Western Blotting to check protein expression. But this means we spend a great deal of money on antibodies, which I feel may be unnecessary. In addition, we would like to identify several unknown proteins in the gels, possibly degradation
GPMAW lite – Protein Sequence Calculator (and much more)
When working with proteins, you often need to make simple bioinformatics calculations on a specific protein sequence - and for
Common protein contaminants in mass spectrometric protein ID
Questions: Why was Keratin identified in my 1D gel band? Is the Keratin determined by the protein identification service in my 1D
Latest in: mAb analysis See all
Critical reasons why mAbs call for orthogonal HCP analysis techniques
Question: We produce a monoclonal antibody (mAb) product, and our HCP ELISA shows low ppm levels. Recently, I heard that regulatory
Investigation of ubiquitin in purified antibody products
Question: Should we worry about ubiquitin in our mAb? Our process-specific HCP ELISA did not detect Host Cell Proteins (HCPs) in our purified monoclonal antibody (mAb). However, mass spectrometry-based HCP analysis identified ubiquitin in low-ppm amounts. Do you have any suggestions for why the Protein A purification did not remove it? Why did ELISA not detect it? And should we worry about its
Assessing and monitoring the quality of therapeutic mAb products
Question: Which analyses should be part of mAb characterization? I need to ensure the quality and consistency of my mAbs. Do you