Application of mass spectrometry to facilitate advanced process controls of biopharmaceutical manufacture

Autor:	Kazumi Kobayashi, Patrick G Swann, Yelena Lyubarskaya
Rok vydání:	2015
Předmět:	Process (engineering) Computer science business.industry media_common.quotation_subject Process analytical technology Manufacturing engineering Quality by Design Biopharmaceutical New product development Critical to quality Process control Quality (business) business media_common
Zdroj:	Pharmaceutical Bioprocessing. 3:313-321
ISSN:	2048-9153 2048-9145
Popis:	Development and implementation of process analytical technology and real-time release testing (here defined as advanced process controls) requires an approach to product development that emphasizes product and process understanding and process control, based on sound science and quality risk management (i.e., quality by design). Mathematical models can enhance the scientific understanding of a process and can also be explored for their predictive capability. Utilizing advanced process controls and mathematical models for biopharmaceutical products can be challenging given product/process complexity. Recent publications and preliminary work from our group are reviewed to show how the analytical capabilities of mass spectrometry can be leveraged to address these challenges.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::0b10d331f7aeb8cd4cd85be00f33c739 https://doi.org/10.4155/pbp.15.10 Zobrazit plný text záznamu