An Overview of Drug Substance Manufacturing Processes.
AAPS PharmSciTech
; 21(7): 271, 2020 Oct 06.
Article
em En
| MEDLINE
| ID: mdl-33033946
ABSTRACT
To develop a comprehensive understanding of pharmaceutical drug substance manufacturing (DSM) processes, we conducted a data mining study to examine 50 new drug applications (NDAs) approved in 2010-2016. We analyzed the prevalence of several frequently deployed in-process control (IPC) techniques and postreaction workup procedures, as well as the operational conditions specified for reactions and workups. Our findings show that crystallization and high-performance liquid chromatography (HPLC) were the most commonly used workup steps and in-process controls, respectively, in drug substance manufacturing. On average, each NDA implemented 12.6 in-process controls and 11.3 workups. Operation time for reactions and workup procedures varied from a few minutes to multiple days, though 61% of these were between 1 and 10 h.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
Tipo de estudo:
Risk_factors_studies
Idioma:
En
Revista:
AAPS PharmSciTech
Ano de publicação:
2020
Tipo de documento:
Article