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With their molecular specificity for biological targets, monoclonal antibodies (mAbs) have revolutionized the field of research and medicine. Due to numerous post-translational modifications causing heterogeneity in the structure of mAbs, a comprehensive characterization of the physiochemical properties is necessary to ensure the quality, efficacy and safety of mAb-based therapeutic drugs.
The development and successful commercialization of gene therapy technologies as new treatments have spurred great interest and investments in this field of research. Many challenges remain to be solved to establish gene therapy as a mainstream line of treatment, but there are currently many promising and life-changing gene therapy programs in preclinical and clinical development.…
The first steps of infection with SARS-CoV-2 is binding of a viral Spike protein to a host receptor angiotensin-converting enzyme 2 (ACE2), followed by fusion of viral and host membranes. Antibodies that block this interaction are emerging as early COVID-19 therapies, however, the neutralization potencies of the antibodies are less studied.
A Rapid LC-MS Assay for Monitoring of mAb Oxidation at the Subunit Level Methionine oxidation is considered a critical quality attribute of therapeutic antibodies and may impact the clinical safety and efficacy. Therefore, monitoring of methionine oxidations is required during the discovery, development, and production of therapeutic antibodies. Traditional methods to characterize oxidation rely…
Scientists at Leiden University Medical Center (LUMC) present a multilevel mass spectrometry approach using SmartEnzymes for in-depth characterization of mammalian SARS-CoV-2 receptor-binding (RBD) domains. The COVID-19 disease caused by the SARS-CoV-2 virus has affected more that 100 million individuals in the ongoing pandemic. The enveloped RNA corona virus contains three structural proteins in the…
Biopharmaceuticals, including monoclonal antibodies (mAbs), have become an important class of therapeutics. The manufacturing procedure of mAbs is complex, and many possible variants of a particular mAb can be generated as a result of enzymatical and chemical modifications. Some of these modifications are critical for the efficacy and safety of the therapeutic mAb and are…
The development of antibody-drug conjugates (ADCs) has evolved from first generation formats prepared by random conjugation technologies to next generation ADCs generated by site-specific conjugation. While significant improvements in overall efficacy and safety is displayed by site-specific formats, bioanalysis remains challenging due to complex in vivo biotransformation events including deconjugation, linker-payload cleavage and payload metabolism.…
Genovis launches FucosEXO, an α-fucosidase mix for efficient removal of α1-2, α1-3 and α1-4 linked Fucose on native N- and O-glycosylated proteins. Analysis of glycoproteins modified with complex glycan structures can be challenging and requires efficient and specific enzymatic tools. FucosEXO is a mix of α-fucosidases for efficient hydrolysis of α1-2, α1-3 and α1-4…
In recent years, bispecifics have gained popularity due to their therapeutic advantages over conventional IgG’s. In particular, the T-cell bi-specifics have received a great deal of attention due to their potential for improved efficacy. However, because of their complex TCB formats, there are multiple challenges associated with manufacturing and analysis of these type of biomolecules.…
A charge heterogeneity is an unfavorable phenomenon observed for mAbs and is considered as a critical quality attribute since it can alter the efficacy and pharmacokinetics of biopharmaceuticals. Acidic and basic species of an IgG are due to various chemical modifications on the molecule. The origin of acidic species has previously been reported to be…
The use of IgG-based antibodies in various clinical fields have increased over that past decades, continuing the development of better biopharmaceuticals. The use of other immunoglobulins including IgA, characterized with the ability to recruit effector cells, is progressively being considered a useful alternative. The complexity of the heavily glycosylated IgA does however pose analytical challenges…
Super resolution microscopy techniques such as stimulated emission depletion microscopy (STED) improves imaging resolution compared to conventional light microscopy. In STED microscopy, super resolution is achieved using photoactivatable dyes that are excited and de-excited selectively with a laser to restrict fluorescense to a specific focal point. While such super resolution methods in combination with immunostaining…
