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In a recent paper, Sokolowska and colleagues at Janssen Research and Development qualified and covalidated a subunit LC-MS method for quality control and stability testing of the oxidation status of commercial antibodies. LC-MS is commonly used for therapeutic antibody development and characterization within the biopharmaceutical industry due to the inherent strengths to provide site-specific…
Scientists at Genentech and the University of Geneva have used FabRICATOR-HPLC to set up an automated workflow for the analysis of monoclonal antibodies by LC-MS. Developing and manufacturing therapeutic antibodies requires the analysis of many product quality attributes. Robust and fast analytical methods are needed to support process development and quality control. In this…
Proline isomerization can occur in the antigen binding complementary determining regions (CDRs) of an antibody and impact the interaction with the antibody target. In this paper, scientists at Sanofi in Vitry-sur-Seine, France, found an unusual size exclusion chromatography profile of a trispecific anti-HIV antibody and determined that the heterogeneity originated from a proline isomerization. …
Scientists at Janssen and Celgene use SmartEnzymes to analyze symmetric and asymmetric structure–function relationships of modified bispecific antibodies. Forced degradation studies are useful for quickly evaluating critical quality attributes. Such modifications may have different biological impacts depending on if they occur symmetrically, in both chains of the antibody, or asymmetrically, in only one chain. In the recently published article, Evans et…
Bo Holmqvist at ImaGene-iT gives us insight about microscopy imaging and how ImaGene-iT is using the site-specific GlyCLICK® technology to obtain high-quality fluorescence images. Tell us about yourself and ImaGene-iT? I am CSO at ImaGene-iT, an independent contract research company supporting the life science industry and academia. Concurrently, as associate professor in experimental pathology, I have a research background in histology and…
Middle-level analysis is a universally accepted analytical strategy for rapid characterization of antibodies. The FabRICATOR® (IdeS)enzyme specifically digests IgG below the hinge, generating fragments that are suitable for high-resolution mass spectrometry. By immobilizing the FabRICATOR enzyme in an HPLC column format, a fully automated on-column digestion of IgG is possible. In a recent article…
Monoclonal antibodies (mAbs) are complex macromolecules that undergo a wide range of post-translational modifications that can result in charge heterogeneity. Ion exchange (IEX) chromatography is considered the gold standard for characterization of charge variants. This approach separates charge variants and allows for the collection of isoforms for protein identification by mass spectrometry (MS). However, the…
Bispecific monoclonal antibodies (BsAbs) are multi-functioning and complex biologics with the ability to recognize two different epitopes for improved therapeutic properties. Characterizing protein modifications such as glycation on biologics is vital to ensure consistency in stability and function. The structural complexity of BsAbs requires robust analytical methods, where conventional top-down and bottom-up strategies may lack…
Antibody drug conjugates (ADCs) consist of monoclonal antibodies chemically linked to a cytotoxic agent. The target specificity of the monoclonal antibody in combination with the potency of the cytotoxic drug make ADCs promising therapeutic agents. However, the molecules are often complex, making evaluation of the quality attributes for the ADC challenging. In order to…
The process of characterizing an antibody drug conjugate (ADC) requires the evaluation of critical quality attributes including primary sequence analysis and drug conjugation assessment. Addressing glycoprofile determination as well as drug load distribution and drug-to-antibody ratio (DAR) is however challenging using peptide mapping. In addition, further challenges arise from the increased hydrophobicity of the ADC…
We got the opportunity to talk to Aaron Bailey at BGI Americas. From their newly setup MS labs, they use SmartEnzymes to help provide analytical services to their customers globally. Read on to find out more. Tell us about yourself and BGI? Currently I work at BGI Americas as the Associate Director of Product Management for Mass Spectrometry…
Johny joined the Genovis team in August, and he brings more than 25 years of financial experience to the company. We are very excited to have you in the team, Johny! Welcome! Tell us a bit about yourself I live in Malmö, in the southern part of Sweden and I have two daughters. I…
