Scientific Library: results

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.

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.

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.

Characterisation of Anti-HCP antibodies by 2D differential Gel Electrophoreses

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.

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.

Development and optimization of a TNFα neutralizing assay using a Quality by Design approach

Development and optimization steps are of major importance to ensure the delivery of reliable results in the routine use of a bioassay. Quality by Design (QbD) approach requires a combination of thorough knowledge of the scientific background of the assay and the use of proper statistical tools to achieve best results.

Absolute quantification of proteins & mAbs by ICP-MS

Although drug products issued from biotechnology have now been marketed for many years, accurate protein quantifcation remains a challenge.

State-of-the art LC/MS methods applied to the characterisation of a highly-glycosylated fusion protein: Etanercept

A large number of pharmaceuticals are glycosylated proteins. An adequate glycosylation is critical for therapeutic proteins in terms of safety, bioactivity, solubility, stability, and pharmacokinetics and dynamics.

Multi-level mass spectrometric characterisation of Antibody-Drug Conjugates in a regulated environment.

Antibody-Drug Conjugates (ADCs) are antibodies engineered to deliver a cytotoxic agent specifically to tumor cells expressing a defined antigen.

Development and use of 2D-LC/MS as a versatile and powerful tool for the analysis of mAbs and ADCs in a regulated environment.

In the recent years, monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) have emerged as potent and specific anticancer agents. However, due to their size, complexity, and heterogeneity, their physico-chemical characterisation requires a large number of assays aimed at verifying their sequence identity, post-translational modifications, and – in the case of ADCs – range/average number of conjugated drugs (Drug-to-Antibody Ratio: DAR). To this end, we have developed a range of analytical workflows employing mass spectrometry, in a regulated environment, to support pharmaceutical companies in the development and control of their mAbs and ADCs.