WebMar 23, 2024 · In this study, we carried out a physicochemical and functional characterisation of nivolumab, which was subjected to various stress conditions: heat, freeze/thaw cycles, agitation, light exposure... WebApr 1, 2024 · Therapeutic proteins may undergo various chemical degradation processes, including oxidation, deamidation, isomerization, hydrolysis, deglycosylation, racemization, disulfide bond breakage and formation, Maillard reaction, and β-elimination.
Immunogenicity of protein aggregates of a monoclonal antibody …
WebSep 5, 2016 · Monoclonal antibodies (mAbs) are the fastest-growing biological therapeutics with important applications ranging from cancers, autoimmunity diseases … WebFeb 10, 2024 · Using mAbs as therapeutic molecules is complicated by the propensity of mAbs to aggregate at elevated concentrations, which can lead to a variety of adverse … susanna\\u0027s dream
Unexplored Excipients in Biotherapeutic Formulations
WebAbstract Objective: In this study, we aimed to investigate the immunogenicity of protein aggregates of monoclonal antibodies (mAbs), generated by forced shaking stress with siliconized and nonsiliconized syringes in a mouse model. Methods: Samples were filled in siliconized and nonsiliconized syringes with shaking and headspace air. WebForced degradation studies are an integral part of recombinant mAb therapeutics research and development throughout the life-cycle of the products for various purposes. Firstly, it can be used to evaluate the manufacturability of multiple candidates by assessing the propensity to degrade under relevant process, formulation, and storage conditions. WebMar 25, 2024 · Therapeutic mAbs have a propensity to aggregate under a variety of environmental conditions, similar to proteins in biological system. 1,2 Protein aggregation in biological systems was reported to correlate with age-related or neurodegenerative-related diseases such as Alzheimer’s and Parkinson’s disease. 3 Whereas, therapeutic mAb … barcelone vs galatasaray