[Analysis of Quality Management of Diagnostic Reagent Clinical Trials].

Clinical trial is an important step of diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of diagnostic reagent clinical trials by analyzing the issues.

Inhibition effect of thiol-type antioxidants on protein oxidative aggregation caused by free radicals.

This study was aimed to investigate the inhibition effect of thiol-type antioxidants on protein oxidative aggregation caused by free radicals and the underlying mechanisms using six different thiol-type antioxidants (N-acetyl-L-cysteine, methionine, taurine, alpha-lipoic acid, glutathione and thioproline), Cu-HO as a free radical generator (mainly a hydroxyl radical generator) and bovine serum albumin as the model protein. The inhibition effect of these antioxidants on protein oxidative aggregation and protective effect against oxidative damage in mouse brain tissues were investigated using SDS-PAGE, intrinsic fluorescence, simultaneous fluorescence, thioflavin T fluorescence, Congo red absorbance and inverted microscope. The results showed that all six antioxidants could inhibit protein oxidative aggregation by scavenging free radicals.

Protein Aggregation and Performance Optimization Based on Microconformational Changes of Aromatic Hydrophobic Regions.

Protein aggregation is a key concern in biopharmaceutical development and manufacturing. There is growing interest in understanding how the changes in protein microconformation affect the aggregation behavior. This study selected several representative proteins and first manipulated microconformational changes of the aromatic hydrophobic regions of proteins, especially tryptophan residues, by using amine or guanidine additives.