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Objective To perform methodological validation of non-reduced capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS) for monoclonal antibodies, providing a reference for the methodological validation of corresponding quality control methods in the industry. Methods Samples were analyzed according to the general chapter ＜3127＞ determination method for monoclonal antibody molecular size variants in the Pharmacopoeia of the People's Republic of China (2020 edition). Two laboratory technicians performed experiments over three days, using the same detection method daily to analyze the test samples, alongside comprehensive methodological validation. Results The method demonstrated good specificity, with the accuracy of the main peaks of all analytical samples reaching 98% to 102%, and the accuracy of total fragments and specific impurities reaching 70% to 130%. The relative standard deviation (RSD) for repeatability and intermediate precision was ≤15%. The ranges for the main peak, total fragment, and specific impurity were ≥89.9%, 0.66% to 10.10%, and 0.36% to 4.80%, respectively.The limit of quantification of the method was 0.33%. Conclusion Full validation demonstrates good accuracy, precision, linearity, range, limit of quantification, and specificity of the method, providing a reference for the scientific and rational design of corresponding methodological validations.

Changes of customer requirements (CRs) are inevitable disturbances for products which will lead to product obsolescence or frequent redesign. The property of product defending and recovering from the shock of ever-changing CRs is resilience. It is beneficial for designers to explore and evaluate product resilience towards changing CRs. Fortunately, various resilience assessment methods in engineering realm have offered some significant insights. Motivated by the deficiencies of the existing studies and the advantages of engineering resilience assessment methods, product resilience towards changing CRs is measured. Firstly, joint customer satisfaction is defined by integrating competition analysis and importance analysis. Secondly, the evolution trends of CRs are depicted and captured based on a modified grey model and polynomial fitting, respectively. Then, a three-stage model considering absorption, adaptation, and recovery is established to evaluate product resilience. Lastly, a case study of an electric vehicle is implemented to elucidate the utility and effectiveness of the proposed method. [ABSTRACT FROM AUTHOR]

Product structural properties are fundamental in product structure optimisation and design. Due to the inevitable evolution of products, product structural properties also change accordingly. Although the evolution of the product structure has been preliminarily investigated, it is mainly analyzed from the viewpoint of commonalities for product generations, and the evolution trend of product structure across product generations has not been well explored. To provide product development direction for designers, this study aims at uncovering the evolution characteristics of product structural properties based on the time-dependent network model. Firstly, weighted time-dependent networks are constructed to represent the cross-generation product structures. Secondly, product structural properties (including complexity, importance, and robustness) are analyzed benefited from topology similarities between product structures and complex networks. Thirdly, 25 generations of iPhones are selected to analyze the evolution characteristics of product structural properties. The results show that in the evolution of product structures, the complexity of the product is decreasing while core components are becoming more complex owing to scale-free property. And the core components are always important in each product generation. Additionally, the evolving product structural networks are highly robust in random failure of components (RFC) and vulnerable in the failure of core components (FCC). [ABSTRACT FROM AUTHOR]

In the process of product design, design changes are unavoidable due to the diversification of customer requirements and the advancement of key technologies. Although modules are supposed to be functionally independent and "low-coupling" in modular products, the design change in a module can still propagate into other modules due to the interfaces among them, and this propagation increases the product development lead-time and costs. This study aims to solve the problem of cross-module propagation in design change. First, the dependence of modules on interfaces is analyzed from the perspectives of complex network characteristics, change propagation characteristics, and cost dependence, and then the correlation between modules is determined. Second, the cross-module change propagation impact is evaluated considering node importance, change cost, and propagation path length. The control strategies of cross-module design change propagation are proposed from the aspects of increasing the tolerance of interface and reducing the dependence of modules on interface, etc. Finally, a certain type of sanitation vehicle cab is utilized as an example to demonstrate the assessment process of the cross-module propagation impact of design change and to verify the feasibility of the proposed method and control strategies. [ABSTRACT FROM AUTHOR]