This post describes the remaining sixmonoclonal antibody peer-reviewed articles from Katie’s list. (Katie is one of one of our biopharmaceutical marketing specialists and I asked her if she had a list of her top monoclonal antibody peer-reviewed articles to share with our blog readers. She came up with a list of 12 articles, of which the first six were reviewed in a previous blog post.)
Synopsis: This article discusses the abilities and performance achieved characterizing monoclonal antibody heterogeneity with the Thermo Scientific Dionex ProPac HIC-10 column. The article discusses various examples of monitoring, including isomerization, succinimides, low potency molecule populations, oxidation and HIC analysis of aggregate and clipped antibody species.
Synopsis: The ever increasing demand for IgG production has resulted in researchers exploring alternate options for monoclonal antibody production. The following article discusses methods of characterization of MAbs from non-mammalian cell cultures in order to reduce cost and cultivation time. Researchers utilized the Dionex ProPac WCX-10 to compare charge heterogeneity of antibodies produced from methylotrophic yeas versus those produced from CHO cells.
Synopsis: Monitoring charge variants is an essential part of monoclonal antibody characterization. Usually, this profiling is done via ion-exchange chromatography. This article discusses a new approach to this classic analysis technique, where a pH gradient based separation is implemented, revealing a multiproduct charge sensitive MAb separation method. In this method, the buffer composition and concentration are increased to achieve separation and a single method can be used to separate monoclonal antibodies with varying iso-electric points. The authors reported that when using this technique with the Dionex ProPac column series, they found improvements in resolution and peak capacity, with simplified method development.
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Synopsis: Size exclusion liquid chromatography is one of the most commonly used methods to characterize monoclonal antibody aggregates. The following journal details a novel way to interlace size exclusion injections for monoclonal antibody aggregate analysis, in order to maximize sample throughput. This method uses the Dionex UltiMate 3000 X2 dual channel bio-compatible LC system to increase sample throughput by approximately two-fold, without reducing the quality of separation. Additionally, this approach can be combined with other high-throughput tactics, such as smaller particle and shorter columns and higher flow rates to further maximize throughput while maintaining excellent resolution.
Synopsis: This article, featured in BioPharm International, addresses some of the current challenges in monoclonal antibody characterization, screening and analysis. By implementing an integrated MAb analysis platform, orthogonal assays are used to evaluate size and charge heterogeneity, the critical quality attributes of monoclonal antibody analysis. By integrating the capability to screen a large number of MAbs in a single platform, you can compile a very detailed analytical profile of your protein, including aggregate assessment and charge variant analysis, in a minimal amount of time.
Synopsis: This article discusses a method that couples high-performance anion-exchange (HPAE) chromatography with pulsed amperometric detection (PAD) to separate and detect neutral and sialylated oligosaccharides from monoclonal antibodies. Some of the advantages to HPAE-PAD highlighted in this article include:
- High sensitivity and excellent resolution for separating and detecting oligosaccharides without any derivatization needed
- Monitors batch to batch variability of the oligosaccharide composition in the production of monoclonal antibodies
- Separates commonly found oligosaccharides in MAbs better than in previously reported methods, especially during high occurrence of siaylated glycans
- Compares favorably to MALDI-TOF MS with advantages that include:
- Higher precision
- Easier automation (with LC autosampler)
- The ability to simultaneously analyze both neutral and sialyated oligosaccharides
- Separation of many structural isomers not possible using MALDI-TOF-MS
- Enables quantification in absolute terms using external calibration
Again, if you have any articles that you would like to share, do add in the Comments section below.