Affiliation:
1. Department of Chemical and Biochemical Engineering Rutgers, The State University of New Jersey Piscataway NJ USA
2. Department of Chemical and Biomolecular Engineering University of Delaware Newark DE USA
Funder
U.S. Food and Drug Administration
Subject
Inorganic Chemistry,Organic Chemistry,Pollution,Waste Management and Disposal,Fuel Technology,Renewable Energy, Sustainability and the Environment,General Chemical Engineering,Biotechnology
Reference181 articles.
1. An overview of FDA-approved biologics medicines
2. Ahmed A;India's biocon secures approval to use drug on coronavirus patients 2020.https://www.reuters.com/article/india-biocon-idINKCN24C0JU
3. Model-based computer-aided framework for design of process monitoring and analysis systems
4. FDA Center for Drug Evaluation and Research.Guidance for industry PAT ‐ a framework for innovative pharmaceutical development manufacturing and quality assurance (Docket No. FDA‐2003‐D‐0032). Available:https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/pat‐framework‐innovative‐pharmaceutical‐development‐manufacturing‐and‐quality‐assurance(2004).
5. Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control
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