Quality by Digital Design for Developing Platform RNA Vaccine and Therapeutic Manufacturing Processes

Author:

Nair Adithya,Loveday Kate A.,Kenyon Charlotte,Qu Jixin,Kis Zoltán

Publisher

Springer US

Reference75 articles.

1. Juran on quality by design: the new steps for planning quality into goods ... – J. M. Juran – Google Books. https://books.google.co.uk/books?id=xjAJnwEACAAJ&printsec=copyright&redir_esc=y#v=onepage&q&f=false. Accessed 9 July 2023

2. Daniel S, Kis Z, Kontoravdi C, Shah N (2022) A blueprint for quality by digital design to support rapid RNA vaccine process development, manufacturing & supply. Vaccine Insights 01:219–233. https://doi.org/10.18609/VAC.2022.33

3. Rathore AS, Winkle H (2009) Quality by design for biopharmaceuticals. Nat Biotechnol 27(1):26–34. https://doi.org/10.1038/nbt0109-26

4. Nasr MM; Cder O, Fda (2011) Implementation of Quality by Design (QbD)-current perspectives on opportunities and challenges topic introduction and ICH update

5. Q8(R2) Pharmaceutical Development | FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q8r2-pharmaceutical-development. Accessed 10 July 2023

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