Modes of Degradation and Impurity Characterization in rhPTH (1-34) during Stability Studies [0.03%]
rhPTH (1-34)稳定性研究中的降解和杂质模式及表征
Ruchi Kothari,Vinod Kumar,Rajender Jena et al.
Ruchi Kothari et al.
During storage of recombinant human parathyroid hormone (rhPTH) (amino acid residues 1-34) at 25 ± 2 °C, several impurities were obtained, which were detected by the tricine sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-P...
Author response [0.03%]
作者回复
Jennifer C Gray
Jennifer C Gray
Letter to the editor [0.03%]
致编辑的信
Tony Cundell
Tony Cundell
Praful Balavant Deshpande,G Aravind Kumar,Averineni Ranjith Kumar et al.
Praful Balavant Deshpande et al.
In light of environmental apprehension, supercritical fluid technology (SFT) exhibits excellent opportunities to accomplish key objectives in the drug delivery sector. Supercritical fluid extraction using carbon dioxide (CO(2)) has been rec...
Excipients and their role in approved injectable products: current usage and future directions [0.03%]
辅料及其在已批准注射产品中的作用：当前使用及未来发展方向
Sandeep Nema,Ronald J Brendel
Sandeep Nema
This review article is a current survey of excipients used in approved injectable products. Information provided includes concentration ranges, function, frequency of use, and role in dosage form. This article is an update of a paper publis...
Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework [0.03%]
基于六西格玛的生物工艺质量设计框架开发
Beth Junker,Mike Kosinski,David Geer et al.
Beth Junker et al.
An initial quality-by-design (QbD) framework was assembled for biopharmaceutical product, process, and analytical development using the design-for-six-sigma (DFSS) methodology. This technique was both streamlined and efficient, which permit...
Molecular applications to pharmaceutical processes and cleanroom environments [0.03%]
分子在制药过程及洁净室环境中的应用
Luis Jimenez
Luis Jimenez
This review article discusses several technologies using the power of genetic analysis that were used to rapidly detect microbial contamination, provide a more accurate identification of microorganisms, understand the microbial diversity in...
How risky are pinholes in gloves? A rational appeal for the integrity of gloves for isolators [0.03%]
手套针孔的风险有多大？隔离器手套完整性的理性诉求
Angela Gessler,Alexandra Stärk,Volker Sigwarth et al.
Angela Gessler et al.
Isolators provide a high degree of protection for the product and/or the environment and operators in pharmaceutical production, as well as for analytical and sterility testing. Gloves allow for performing testing and for easy access to the...
Risk analysis of sterile production plants: a new and simple, workable approach [0.03%]
无菌药品生产厂房的风险管理：一种新的、简单的实用办法
Guenther Gapp,Peter Holzknecht
Guenther Gapp
A sterile active ingredient plant and a sterile finished dosage filling plant both comprise very complex production processes and systems. The sterility of the final product cannot be assured solely by sterility testing, in-process controls...