Analysis of Oligonucleotides by Size-Exclusion Chromatography: SEC-UV, SEC-MS, SEC-MALS
The field of therapeutic oligonucleotides has seen remarkable progress over the last years.
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Publication & Application notes
Implementation and development of OCTET Red96e BLI platform
Biologics (monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, etc.) are a class of complex molecules used in a wide range of therapeutic indications, including cancers and auto-immune diseases.
Interlaboratory Evaluation of a User-Friendly Benchtop Mass Spectrometer for Multiple-Attribute Monitoring Studies of a Monoclonal Antibody
(1) Quality Assistance sa, Technoparc de Thudinie 2, 6536 Thuin, Belgium
(2) School of Pharmaceutical Sciences, University of Geneva, CMU—Rue Michel Servet 1, 1211 Geneva, Switzerland
New 2D-LC–MS Approaches for the Analysis of In-Process Samples and for the Characterisation of mAbs in a Regulated Environment
Biologics, and in particular monoclonal antibodies (mAbs), are an important class of therapeutics, and their market share keeps growing. The production of antibodies is a complex and lengthy process.
Validation of a Monocyte Activation Test (MAT) using the PyroMAT™ kit
Pyrogen testing is a regulatory requirement to ensure the product quality and safety of pharmaceutical products, as pyrogens can induce life threatening fever reactions.
Capillary isoelectric focusing (icIEF) bridging study between iCE3 and Maurice equipment
Monoclonal antibodies (mAbs) constitute a major and fast-growing biotherapeutic class, thanks notably to their outstanding selectivity for specific targets.
A new alternative tool to analyse glycosylation in pharmaceutical proteins based on infrared spectroscopy combined with nonlinear support vector regression
(a) University of Liege (ULiege), CIRM, Vibra-Sante Hub, Department of Pharmacy, Laboratory of Pharmaceutical Analytical Chemistry, Liege, Belgium
Quantification of residual CHO host cell DNA in biotherapeutics in-process samples using KingFisher Flex system
The presence of residual host cell DNA in biopharmaceutical products can induce severe side effects for patients.
Development and validation of an antibody-drug conjugate bioassay
Antibody-drug conjugates (ADCs) are a class of drugs used in the treatment of different cancers. Unlike chemotherapy, ADCs are designed to only target and kill tumour cells. Structurally, ADCs are complex molecules composed of an antibody linked to a cytotoxic co
DryLab and Empower: a successful combination for the optimisation of mAb subunit analysis
The development of liquid chromatography (LC) methods has long been done using a trial-and-error approach, also known as “one factor at a time” (OFAT). While this approach is the easiest to implement, it is both time-consuming and quite inefficient.
Fast and accurate absolute quantification of antibodies and antibody-drug conjugate using Isotope Dilution-Triple Quadrupole ICP-MS
Traditional “absolute” methods of analysis for protein quantification include colorimetry, amino acid (AA) analysis and UV-Vis spectroscopy but each of these techniques has its limitations.
Development and validation of home-made Luminex assays for the quantification of multiple cytokines in human samples
Cytokine profiling is a powerful tool to link the host immune system with disease pathogenesis and/or treatment efficacy.
Development of orthogonal chromatographic methods for the purity analysis of therapeutic oligonucleotides
This application note presents the results obtained for the development of different HPLC methods on model therapeutic oligonucleotides, including R&D-grade Nusinersen, an approved 18-mer phosphorothioate oligonucleotide with 2’-O-(2-methoxyethyl) modifications.
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Absolute Quantification of Oligonucleotides by ICP-MS/MS
A method was developed for the absolute quantification of purified therapeutic oligonucleotides, based on phosphorus determination by
ICP-MS/MS.
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New 2D-LC/MS approaches for the analysis of in-process samples and for the characterisation of mAbs in a regulated environment
Two applications are presented here and describe the use of a 2D-LC system for MS characterisation of mAbs without sample preparation.
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Charge variants analysis of monoclonal antibodies
Charge variants are considered as a Critical Quality Attribute of therapeutic monoclonal antibodies, as they can have a significant impact on the efficacy of the drug. State-of-the-art analytical techniques are required to both quantify and identify the variants. In this application note, we present the portfolio proposed by Quality Assistance, including capillary isoelectric focusing (cIEF) and ion-exchange chromatography (IEX), with applications to commercial monoclonal antibodies. Approaches based on (2D-)LC/MS are presented for the identification of the variants.
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Development, optimisation and validation of a TNFα neutralising assay using a Quality by Design approach
Using a QbD approach, we developed a TNFα neutralising assay capable of fulfilling the Analytical Target Profile. Statistical Design of Experiment was applied to evaluate the effect of the different factors and to choose the optimal parameters.
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Innovative ICP-MS/MS approach for the determination of phosphodiester to phosphorothioate ratio in phosphorothioate oligonucleotides
Phosphodiester to phosphorothioate ratio (P=O/P=S) is a critical quality attribute of phosphorothioate oligonucleotides. The determination of this ratio is commonly performed by P-NMR, which requires specific equipment and cannot be easily applied in a regulated (GxP) environment. For the first time, we present in this application note the preliminary results obtained for the development of an ICP-MS/MS method to determine P=O/P=S ratio.
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Stress testing of Humira (adalimumab) monitored by Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS)
In this application note, we present how this technology can be used to monitor structural changes at the amino acid level during stress testing studies of a monoclonal antibody. This appreach can be applied similarly to stability studies.
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Epitope mapping of an interleukin receptor for three therapeutic antibodies by Hydrogen-Deuterium Exchange Mass Spectrometry (HDX-MS)
In this application note, we present a case study in which we performed epitope mapping for three monoclonal antibodies binding to an interleukin receptor.
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Analytical Characterisation of Cell-Based Medicinal Products
Ensuring the characterisation of in vitro differentiated cells for therapeutic purposes brings many challenges. These include the difficulty of controlling cell variability and complexity of the steps required to generate a stable product.
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Analytical approaches for the evaluation of ADCC activity of mAbs
Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) is amechanism of action of antibodies through which virus-infected or cancer cells are targeted for destruction by components of the cell-mediated immune system, such as natural killer cells.
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Customised labelling of antibodies: A powerful tool for multi-parameters analyses in Flow Cytometry
The characterisation of biomarkers by flow cytometry is an attractive approach for Quality Control applications of cell products. Unfortunately, the design of a customised panel remains challenging, especially for stem cell products.
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Characterisation of the glycosylation of Humira (adalimumab) and Erbitux (Cetuximab) by high resolution mass spectrometry
Due to their mode of production, therapeutic mAbs present diverse and heterogeneous glycosylations. Their analysis may require the use of orthogonal techniques in order to fully characterize their nature and location. In this application note, the use of mass spectrometry as a powerful tool for Adalimumab and Cetuximab glycosylation characterization is presented.
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Characterisation of Anti-HCP antibodies by 2D differential Gel Electrophoresis
Host-cell proteins are a major class of process-related impurities in biotherapeutics that can impact the safety and efficacy of the product. Despite the advent of advanced analytical techniques, ELISA remains as the industry gold standard for the detection and quantification of HCPs during process development and for routine analyses.
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Characterisation of Antibody-Drug Conjugates by High-Resolution Mass Spectrometry
Due to their mode of production and conjugation chemistry, antibody-drug conjugates are complex and heterogeneous molecules. Their analysis usually requires the use of many orthogonal analytical techniques in order to fully characterise their different variants and drug-to-antibody ratio.
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Characterisation of the glycosylation of Enbrel: Etanercept by high resolution mass spectrometry
Due to their mode of production, therapeutic glycoproteins present complex and heterogeneous glycosylations. Their analysis usually requires the use of many orthogonal analytical techniques in order to fully characterise their nature and location.
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Human platelet lysate as additive for Wharton's Jelly-MSC culture
This application note presents the results obtained during a study performed to evaluate the use of human Platelet Lysates (hPL) as an alternative to Fetal Bovine Serum (FBS) in culture media for Mesenchymal Stem Cells (MSC)
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Surface Plasmon Resonance
Biotherapeutics are a class of complex molecules that require the use of innovative techniques for their characterisation. Biacore technology offers label-free assays that provide precise and reliable concentration and kinetic measurements.
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Characterisation of Humira Adalimumab by high resolution mass spectrometry
Due to their mode of production, monoclonal antibodies are complex and heterogeneous molecules. Their analysis usually requires the use of many orthogonal analytical techniques in order to fully characterise the different variants.
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Fast and accurate absolute-quantification of proteins and antibodies using Isotope Dilution-Triple Quadrupole ICP-MS
Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is used increasingly in metallomic studies to analyze metals and metal species and their interactions within biological and ecological systems.
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