Quality by Design risk assessments supporting approved antibody products
Author:
Publisher
Informa UK Limited
Subject
Immunology,Immunology and Allergy
Link
https://tandfonline.com/doi/pdf/10.1080/19420862.2016.1232218
Reference14 articles.
1. Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program
2. Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management
3. CMC Biotech Working Group. A-MAb: A Case Study in Bioprocess Development. Emeryville, CA: CASSS, 2009. http://www.casss.org/?page=286
4. Considerations for Biotechnology Product Quality by Design
5. Quality by design for biopharmaceuticals
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