Articles tagged ”FabRICATOR”

SmartEnzymes™ for Gene Therapy

May 11, 2022 | News, Products |

The development of advanced gene therapies is promising and gives thousands of patients new hope for a curative treatment. However, many of the current gene therapies are using adeno-associated viruses as transporters of new genetic material. Up to 60% of patients may have antibodies against this viral vehicle and this is usually an exclusion criteria for being eligible for gene therapy. To overcome the presence of neutralizing antibodies, a new strategy includes the use of highly specific IgG proteases to digest the antibody population and increase the uptake of the new genetic material.
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FabRICATOR® in an Inline Electrochemical Reduction Workflow

February 17, 2022 | References |

An inline electrochemical reduction workflow for antibodies coupled with LC-MS analysis is described in this paper from the National Institute for Bioprocessing Research and Training in Dublin. The FabRICATOR enzyme (IdeS) is a key component in the subunit analysis by digesting antibodies at a single site below the hinge, generating a homogenous pool of F(ab’)2 and Fc subunits.
 
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FabRICATOR® in a DAR Analysis of Antibody-Oligonucleotide Conjugates

September 16, 2021 | Applications, References |

In this paper, scientists at Spectroswiss and Orion Pharma present a novel strategy for DAR analysis of structurally complex antibody-oligonucleotide conjugates using SmartEnzymes™ and a proteoform integration approach combined with native SEC-Orbitrap FTMS.
 
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FabRICATOR in a Comprehensive Characterization of a Bispecific Antibody

September 9, 2021 | Applications, References |

Scientists at University of Geneva and Centre d’Immunologie Pierre-Fabre here describes a comprehensive intact and middle-level characterization of a commercial bispecific antibody by using a variety of orthogonal chromatographic methods coupled to MS.
 
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Purification of Antibody Fragments via Hydrophobic Interactions


The importance of monoclonal antibodies (mAbs) as therapeutic agents is steadily increasing, and each year nearly 300 novel mAbs are being evaluated for their therapeutic effectivity. Interest has also been expressed in the use of antibody fragments as therapeutic agents. The physiochemical properties of the fragments differ significantly from that of intact antibodies, and the fragments can more easily be coupled to dyes, toxins and vesicles for diagnostic purposes, cancer therapy and improved drug delivery, respectively.
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Analytical Methods to Monitor Site-Specific ADC Generation with GlyCLICK®


Scientists at the University of Strasbourg and University of Geneva use innovative native MS and IM methodologies for analytical characterization of a site-specific ADC generated with the GlyCLICK technology.

 

Antibody-drug conjugates (ADCs) combine the benefits of tumor-targeting monoclonal antibodies with the cytotoxic effect of drug payloads covalently linked to the antibody. The ADC generation process has evolved from non-selective and uncontrolled conjugation in early generation products, to site-specific conjugation resulting in homogenous and well-defined ADCs. Conjugation at the antibody Fc glycan sites using the GlyCLICK technology has proven to be an attractive option for the generation of site-specific ADCs.
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Middle-up Analysis of Monoclonal Antibodies using FabRICATOR®


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.
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IgG Proteases for Gene Therapy Applications

June 16, 2021 | Applications |

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. Preexisting antibodies against the capsid of adeno-associated virus (AAV) vectors is a major challenge for many gene therapies that could block uptake and limit the transduction of the new genetic material. The anti-AAV antibodies are prevalent both in humans and preclinical disease models. In patient populations, up to 50% of the patients could be excluded from treatment due to high titers of anti-AAV antibodies. Several strategies are explored to reduce the antibody response, once such is enzymatic pretreatment using IgG-specific proteases.
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New Application Note on Antibody Oxidation Analysis


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 on tryptic peptide mapping and LC-MS, a labor intensive and time- consuming process that generates large data sets and requires trained and skilled manual interpretations.
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FabRICATOR in an Evaluation of Mobile-phase Additives for LC-MS Characterization of mAbs


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 known as critical quality attributes (CQAs). CQAs need to be thoroughly monitored to ensure the quality and safety of the therapeutic agent.

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