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NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
Jennifer L. Mantle and Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 497-508; DOI: https://doi.org/10.5731/pdajpst.2019.011049
Jennifer L. Mantle
National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713
Kelvin H. Lee
National Institute for Innovation in Manufacturing Biopharmaceuticals, 590 Avenue 1743, Newark, DE 19713
References
- 1.↵Center for Drug Evaluation and Research, Guidance for Industry: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry [Draft Guidance Document], 2018. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-core (accessed August 9, 2019).
- 2.↵Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products, 1997. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-approved-application-specified-biotechnology-and-specified-synthetic-biological-products (accessed August 9, 2019).
- 3.↵CMC Biotech Working Group. A-Mab: A Case Study in Bioprocess Development—Version 2.1, 2009. ISPE Web site. https://ispe.org/system/files/magazine-issues/a-mab-case-study-version.pdf (accessed August 9, 2019).
- 4.↵CMC-Vaccines Working Group. A-VAX: Applying Quality by Design to Vaccines, 2012. DCVMN Web site. https://www.dcvmn.org/IMG/pdf/a-vax-applying-qbd-to-vaccines_2012.pdf (accessed August 9, 2019).
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
Jennifer L. Mantle, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 497-508; DOI: 10.5731/pdajpst.2019.011049
NIIMBL-Facilitated Active Listening Meeting between Industry and FDA Identifies Common Challenges for Adoption of New Biopharmaceutical Manufacturing Technologies
Jennifer L. Mantle, Kelvin H. Lee
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 497-508; DOI: 10.5731/pdajpst.2019.011049
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