Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases

A Novel Coronavirus Emerging in China — Key Questions for Impact Assessment

(2020) Vincent J. Munster et al.   NEW ENGLAND JOURNAL OF MEDICINE

Opportunities and Challenges in the Delivery of mRNA-Based Vaccines

(2020) Abishek Wadhwa et al.   Pharmaceutics

Current status of COVID‐19 (pre)clinical vaccine development

(2020) Bruno de Geest et al.   ANGEWANDTE CHEMIE-INTERNATIONAL EDITION

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

(2020) Lisa A. Jackson et al.   NEW ENGLAND JOURNAL OF MEDICINE

Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine candidate induces high neutralizing antibody titers in mice

(2020) Paul F. McKay et al.   Nature Communications

COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses

(2020) Ugur Sahin et al.   NATURE

Evolution of the COVID-19 vaccine development landscape

(2020) Tung Thanh Le et al.   NATURE REVIEWS DRUG DISCOVERY

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates

(2020) Edward E. Walsh et al.   NEW ENGLAND JOURNAL OF MEDICINE

Emerging Technologies for Low‐Cost, Rapid Vaccine Manufacture

(2019) Zoltán Kis et al.   Biotechnology Journal

Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA

(2019) Anna K. Blakney et al.   GENE THERAPY

mRNA vaccines — a new era in vaccinology

(2018) Norbert Pardi et al.   NATURE REVIEWS DRUG DISCOVERY

The Effects of Dithiothreitol on DNA

(2017) Søren Fjelstrup et al.   SENSORS

Quality by design approach: Regulatory need

(2017) Jaiprakash N. Sangshetti et al.   Arabian Journal of Chemistry

Quality by Design risk assessments supporting approved antibody products

(2016) Brian Kelley   mAbs

Understanding Pharmaceutical Quality by Design

(2014) Lawrence X. Yu et al.   AAPS Journal

Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets

(2012) Raafat Fahmy et al.   AAPS PHARMSCITECH

A Multiphysics Model of In Vitro Transcription Coupling Enzymatic Reaction and Precipitation Formation

(2012) Satoru Akama et al.   BIOPHYSICAL JOURNAL

Innovations in vaccine development: can regulatory authorities keep up?

(2012) Manon MJ Cox et al.   Expert Review of Vaccines

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

T7 RNA Polymerase Studied by Force Measurements Varying Cofactor Concentration

(2008) P. Thomen et al.   BIOPHYSICAL JOURNAL