Application of Process Analytical Technology-Based Feedback Control Strategies To Improve Purity and Size Distribution in Biopharmaceutical Crystallization-Reference-Cited by-同舟云学术

Application of Process Analytical Technology-Based Feedback Control Strategies To Improve Purity and Size Distribution in Biopharmaceutical Crystallization

Published:2015-05-01 Issue:6 Volume:15 Page:2908-2919
ISSN:1528-7483
Container-title:Crystal Growth & Design
language:en
Short-container-title:Crystal Growth & Design

Author:

Simone Elena¹,Zhang Wei²³,Nagy Zoltan K.¹³

Affiliation:

1. Department of Chemical Engineering, Loughborough University, Loughborough, LE11 3TU, U.K.

2. New Drug Research and Development Center, North China Pharmaceutical Group Corporation, Shijiazhuang, China

3. School of Chemical Engineering, Purdue University, West Lafayette, 47907, Indiana, United States

Funder

European Research Council

Publisher

American Chemical Society (ACS)

Subject

Condensed Matter Physics,General Materials Science,General Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.cgd.5b00337

Reference30 articles.

1. The Financing of Biopharmaceutical Product Development in Europe - Study on the Competitiveness of the European Biotechnology Industry;European Commission Enterprise and Industry:Copenhagen/Brussels;http://ec.europa.eu/enterprise/sectors/biotechnology/files/docs/financing_biopharma_product_dev_en.pdf.

2. The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and the Factors That Will Drive It;The Pharmaceutical Research and Manufacturers of America (PhRMA) & Battelle, 2014, http://www.phrma.org/sites/default/files/pdf/2014-economic-futures-report.pdf.

3. PAT Guidance for Industry - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance;U.S. Department of Health and Human Services, U.S. Food and Drug Administration:Silver Spring, MD, 2004, http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf.

4. Quality by design for biopharmaceuticals

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