Subvisible Particles Derived by Dropping Stress Enhance Anti-PEG Antibody Production and Clearance of PEGylated Proteins in Mice

Abstract

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The use of RNA-based treatments in the field of cancer immunotherapy

“…The lipid-anchored PEG is incorporated to decrease macrophage-mediated clearance. More importantly, lipid-anchored PEG helps prevent particle aggregation and improve storage stability [483]. For cancer vaccine delivery, LNPs should be designed to protect mRNA from extracellular RNase degradation, and to deliver mRNA encoding antigens specifically to APCs, so to facilitate efficient antigen presentation, whilst not comprise mRNA translation [484].…”

Application of Elastin-like Polypeptide in Tumor Therapy

“…The most commonly studied macromolecular polymer used to covalently bind to proteins is polyethylene glycol (PEG) by a process known as PEGylation, which introduces changes to the physicochemical properties of the protein molecule, thereby increasing its molecular size and weight, hydrophilicity and intermolecular interactions, in addition to changes in conformation. These changes introduced by the PEG help to decrease protein clearance while improving delivery to target sites and have been utilized to modify several commercial and clinically available peptide drugs [ 44 , 45 , 46 ], for which the efficacy and circulating half-life of PEGylated therapeutic proteins have been investigated [ 44 , 47 ]. Similar to PEG, human serum albumin (HSA) has been investigated and clinically tested as a binding module to improve the pharmacokinetics and pharmacodynamics of therapeutic proteins due to its low toxicity, high biocompatibility and apparently stable half-life within the human system [ 48 , 49 ].…”

A Collaborative Study on the Classification of Silicone Oil Droplets and Protein Particles Using Flow Imaging Method

“…Discussion was divided on whether accuracy should be prioritized for SO droplets or protein particles. While protein aggregates are generally believed to be related to the immunogenicity of biopharmaceuticals, it was also reported that soluble and/or insoluble proteins accumulation around SO droplets may elicit undesired immune responses [14,28,29]. Continuously monitoring lot-to-lot consistency in protein particles and SO droplets would be crucial to ensure the quality and safety of prefilled syringe products.…”