A New Approach to Study the Physical Stability of Monoclonal Antibody Formulations—Dilution From a Denaturant

The early-stage assessment of the physical stability of new monoclonal antibodies in different formulations is often based on high-throughput techniques that suffer from various drawbacks. Accordingly, new approaches that facilitate the protein formulation development can be of high value to the industry. In this study, a dynamic light scattering plate reader is used to measure the aggregation (by means of the increase in the hydrodynamic radius [R_h]) of monoclonal antibody samples that were subject to incubation and subsequent dilution from different concentrations of a denaturing agent, that is, guanidine hydrochloride. The increase in the R_h of the protein samples is dependent not only on the denaturant concentration used but also on the buffer in which the incubation/dilution was performed. We also compare the aggregation after dilution from a denaturant with other high-throughput stability-indicating methods and find good agreement between the techniques. The proposed approach to probe the physical stability of monoclonal antibodies in different formulation conditions offers a unique combination of features—it is isothermal, probes both the resistance to denaturant-induced unfolding and the colloidal protein stability, it is entirely label-free, does not rely on complex data evaluation, and requires very short instrument measurement time on standard equipment.     

临床骨折类疾病ICD编码常见问题及对策

目的：通过深入分析骨折疾病的分类，探讨规范不同类型骨折疾病的病案编码方法。方法：通过文献调研，统筹概括各种情形的骨折类疾病的性质和编码方法。结果：提出系统性的骨折类疾病编码流程，方便编码和信息统计人员使用。结论：骨折类疾病病因复杂，多数病种未能概括，编码人员在临床实际编码过程中需认真阅读病案资料，对骨折真正类别进行准确编码。     

Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement

Background

Patients undergoing surgical aortic valve replacement (SAVR) are considered at high risk of infective endocarditis (IE). However, data on the risk of IE following transcatheter aortic valve replacement (TAVR) are sparse and limited by the lack of long-term follow-up as well as a direct comparison with patients undergoing SAVR.

Characterization and Management of Arrhythmic Events in Young Patients With Brugada Syndrome

Background

Information on young patients with Brugada syndrome (BrS) and arrhythmic events (AEs) is limited.

人禽流感的ICD-10编码探讨

1981年至今,人类已确认可感染人的禽流感病毒有H7N7、H5N1、H9N2、H7N2、H7N3、H5N2、H10N7、H7N9八种,其临床表现和病死率相差悬殊,而ICD-10(2008年第2版)提供的人禽流感编码只有类目J09,随着威胁人类的高病死率人禽流感的出现,建议适当增加亚目对人禽流感疾病进行分类,以利于死亡和疾病数据进行系统记录、分析、解释和比较。