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.
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.
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.
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.
In this application note, we present a case study in which we performed epitope mapping for three monoclonal antibodies binding to an interleukin receptor.
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.
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.
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.
Host-cell proteins are a major class of process-related impurities in biotherapeutics that can impact the safety and efficacy of the product.
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.
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.
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)
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.
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.
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.