Whitepaper: BIOshell™ IgG 1000 Å C4 UHPLC column for improved biomacromolecule separations
Monoclonal antibodies (mAbs) are widely manufactured by many biopharmaceutical companies to treat a myriad of diseases ranging from Alzheimer’s disease, Parkinson’s disease, ulcerative colitis, and many types of cancers…
Most recombinant therapeutic mAbs belong to the human immunoglobulin G (IgG) category among the immunoglobulin superfamily.
A general IgG antibody is composed of two light chains (LC) that are tethered to two heavy chains (HC) through disulfide bonds. In addition, due to the fact that the LC and HC are composed of amino acids with reactive side chains, IgG’s can be post-translationally modified through phosphorylation, methylation, oxidation, and nitrosylation, among other modifications. These modifications may change the binding affinity of the mAb so that it binds either the wrong antigen, does not bind any antigen, or associates with the wrong cell surface receptor.
Biopharmaceutical companies need to develop rigorous methods to assess lot-to-lot reproducibility of their candidate biologic drug, and the above mentioned modifications are known as Critical Quality Attributes (CQAs) that both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) monitor. Due to these stringent requirements from regulatory bodies, much research has been pursued in the past 20 years to develop accurate, robust, and high-throughput methods to assess biopharmaceutical purity and structure.
The rest of this whitepaper is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Related content from this organisation
- Key packaging trends for 2019
- Whitepaper: Logistic regression model of the endotoxin standard curve and statistical tests
- Expert View: What ADC evolution means for manufacturing
- Product Hub: High sensitivity pyrogen testing with the PyroMAT™ system: make the move to the next MAT generation
- Biopharma, Processing & Development In-Depth Focus 2018