Imperial College London
Alternate

Professor Nilay Shah OBE FREng

Faculty of Engineering, Department of Chemical Engineering

Professor of Process Systems Engineering
 
 
 
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Contact

 

+44 (0)20 7594 6621n.shah

 
 
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Assistant

 

Miss Jessica Baldock +44 (0)20 7594 5699

 
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Location

 

ACEX 522ACE ExtensionSouth Kensington Campus

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Summary

 

Publications

Citation

BibTex format

@article{van:2021:10.1038/s41541-021-00322-7,
author = {van, de Berg D and Kis, Z and Behmer, CF and Samnuan, K and Blakney, A and Kontoravdi, K and Shattock, R and Shah, N},
doi = {10.1038/s41541-021-00322-7},
journal = {npj Vaccines},
title = {Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases},
url = {http://dx.doi.org/10.1038/s41541-021-00322-7},
volume = {6},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Rapid-response vaccine production platform technologies, including RNA vaccines, are being developed to combat viral epidemics and pandemics. A key enabler of rapid response is having quality-oriented disease-agnostic manufacturing protocols ready ahead of outbreaks. We are the first to apply the Quality by Design (QbD) framework to enhance rapid-response RNA vaccine manufacturing against known and future viral pathogens. This QbD framework aims to support the development and consistent production of safe and efficacious RNA vaccines, integrating a novel qualitative methodology and a quantitative bioprocess model. The qualitative methodology identifies and assesses the direction, magnitude and shape of the impact of critical process parameters (CPPs) on critical quality attributes (CQAs). The mechanistic bioprocess model quantifies and maps the effect of four CPPs on the CQA of effective yield of RNA drug substance. Consequently, the first design space of an RNA vaccine synthesis bioreactor is obtained. The cost-yield optimization together with the probabilistic design space contribute towards automation of rapid-response, high-quality RNA vaccine production.
AU  - van,de Berg D
AU  - Kis,Z
AU  - Behmer,CF
AU  - Samnuan,K
AU  - Blakney,A
AU  - Kontoravdi,K
AU  - Shattock,R
AU  - Shah,N
DO  - 10.1038/s41541-021-00322-7
PY  - 2021///
SN  - 2059-0105
TI  - Quality by design modelling to support rapid RNA vaccine production against emerging infectious diseases
T2  - npj Vaccines
UR  - http://dx.doi.org/10.1038/s41541-021-00322-7
UR  - http://hdl.handle.net/10044/1/88473
VL  - 6
ER  -
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