A Virtual Plant for Integrated Continuous Manufacturing of a Carfilzomib Drug Substance Intermediate, Part 1: CDI-Promoted Amide Bond Formation This article details process characterization efforts and the development of corresponding process models to inform a process control strategy to produce a... Ict...
Christopher J. GalliTransForm Pharmaceuticals/ChemPharm LEX, Johnson & Johnson Pharmaceutical Research and Development, Lexington, Massachusetts, USAJohn Wiley & Sons, LtdPART III BRIDGING FROM DISCOVERY TO DEVELOPMENT. 5 Chemistry, Manufacturing and Controls: The Drug Substance and Formulated Drug Product...
(t-PA); bombesin; thrombin; hemopoietic growth factor; tumor necrosis factor-alpha and -beta; enkephalinase; a serum albumin such as human serum albumin; mullerian-inhibiting substance; relaxin A-chain; relaxin B-chain; prorelaxin; mouse gonadotropin-associated peptide; a microbial protein, such ...
Qi M, Wang P, Wang L (2003) Validated liquid chromatography method for assay of tizanidine in drug substance and formulated products. Anal Chimica Acta 478: 171-77.Qi ML, Wang P, Wang L. Validated liquid chromatography method for assay of tizanidine in drug substance and formulated products....
β-lactam antibiotics, such as penicillin share a very unstable chemical structure. In water-based solutions, such as those used for clinical applications, the β-lactam ring is readily opened due to a nucleophilic or electrophilic attack, leading to the
“Materials science-based characterization of the drug substance using modern compaction simulators, Raman spectroscopy, electron microscopy, chromatography, crystallography, thermal characterization, and dissolution and absorption technologies can help in the characterization,” explains Konagurthu. “Physical ...
CHO long-term cultureprotein drug substance colorbasic variantsmanufacturing process developmentDuring biopharmaceutical process development, it is important to improve titer to reduce drug manufacturing costs and to deliver comparable quality attributes of therapeutic proteins, which helps to ensure patient ...
It is particularly useful for cancers which are resistant to the cytotoxic drug when administered without LDL and for the administration of drugs which are insoluble in non-toxic solvents.BREEZE, ANTHONY S
Effect of cell culture medium components on color of formulated monoclonal antibody drug substance. Biotechnol Prog 2013 ; http://dx.doi.org/ 10.1002/btpr.1772 ; PMID: 23761398Vijayasankaran N, Varma S, Yang Y, Mun M, Arevalo S, Gawlitzek M, Swartz T, Lim A, Li F, Zhang B, et ...