The Influence of Arginine and Counter-Ions: Antibody Stability during Freeze-Drying

Seifert, Ivonne; Bregolin, Alessandro; Fissore, Davide; Frieß, Wolfgang

doi:10.1016/j.xphs.2020.12.009

Cited by 7 publications

(1 citation statement)

References 41 publications

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“…Two major types of stabilizers can be added to the buffer based on their properties: kosmotropes and chaotropes. Kosmotropes, such as sucrose, glycerol, glycine, arginine [9,29], and sorbitol [30], stabilize the native structure of the protein by stabilizing the hydration shell around the protein(Figure 4a). Chaotropes, such as guanidine hydrochloride and urea [9], reduce or hinder protein-protein interactions by interfering with the hydration shell around proteins and weakening it (Figure 4b) [31].…”

Section: Minimize Antigen and Antibody Aggregationmentioning

confidence: 99%

Lot-to-Lot Variance in Immunoassays—Causes, Consequences, and Solutions

et al. 2023

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Immunoassays, which have gained popularity in clinical practice and modern biomedical research, play an increasingly important role in quantifying various analytes in biological samples. Despite their high sensitivity and specificity, as well as their ability to analyze multiple samples in a single run, immunoassays are plagued by the problem of lot-to-lot variance (LTLV). LTLV negatively affects assay accuracy, precision, and specificity, leading to considerable uncertainty in reported results. Therefore, maintaining consistency in technical performance over time presents a challenge in reproducing immunoassays. In this article, we share our two-decade-long experience and delve into the reasons for and locations of LTLV, as well as explore methods to mitigate its effects. Our investigation identifies potential contributing factors, including quality fluctuation in critical raw materials and deviations in manufacturing processes. These findings offer valuable insights to developers and researchers working with immunoassays, emphasizing the importance of considering lot-to-lot variance in assay development and application.

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