Flow Water Proton NMR: In-Line Process Analytical Technology for Continuous Biomanufacturing

Author:

Taraban Marc B.1ORCID,Briggs Katharine T.1,Merkel Peter1,Yu Y. Bruce1

Affiliation:

1. Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States

Funder

National Institute for Innovation in Manufacturing Biopharmaceuticals

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Reference44 articles.

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Pharmaceutical CGMPs, Rockville, MD, September 2004, https://www.fda.gov/downloads/drugs/guidances/ucm070305.pdf, accessed on April 18, 2019.

2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Guidance for Industry. Quality Considerations for Continuous Manufacturing, Draft Guidance, Pharmaceutical Quality/CMC, Pharmaceutical Quality/Manufacturing Standard (CGMP), Rockville, MD, February 2019, https://www.fda.gov/media/121314/download, accessed April 4, 2019.

3. The Future of Pharmaceutical Manufacturing Sciences

4. The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing

5. Advances in downstream processing of biologics – Spectroscopy: An emerging process analytical technology

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