CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness-Reference-Cited by-同舟云学术

CMC Strategies and Advanced Technologies for Vaccine Development to Boost Acceleration and Pandemic Preparedness

Published:2023-06-26 Issue:7 Volume:11 Page:1153
ISSN:2076-393X
Container-title:Vaccines
language:en
Short-container-title:Vaccines

Author:

Castellanos Maria Monica¹,Gressard Hervé²,Li Xiangming³,Magagnoli Claudia⁴,Moriconi Alessio⁵,Stranges Daniela⁵,Strodiot Laurent⁶,Tello Soto Monica⁷,Zwierzyna Magdalena⁸^ORCID,Campa Cristiana⁹^ORCID

Affiliation:

1. Drug Product Development, Vaccines Technical R&D, GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA

2. Project & Digital Sciences, Vaccines Technical R&D, GSK, Rue de l’Institut 89, 1330 Rixensart, Belgium

3. Drug Substance Development, Vaccines Technical R&D, GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA

4. Analytical Research & Development, Vaccines Technical R&D, GSK, Via Fiorentina 1, 53100 Siena, Italy

5. Drug Product Development, Vaccines Technical R&D, GSK, Via Fiorentina 1, 53100 Siena, Italy

6. Drug Product Development, Vaccines Technical R&D, GSK, Rue de l’Institut 89, 1330 Rixensart, Belgium

7. Drug Substance Development, Vaccines Technical R&D, GSK, Rue de l’Institut 89, 1330 Rixensart, Belgium

8. Project & Digital Sciences, Vaccines Technical R&D, GSK, Via Fiorentina 1, 53100 Siena, Italy

9. Vaccines Global Technical R&D, GSK, Via Fiorentina 1, 53100 Siena, Italy

Abstract

This review reports on an overview of key enablers of acceleration/pandemic and preparedness, covering CMC strategies as well as technical innovations in vaccine development. Considerations are shared on implementation hurdles and opportunities to drive sustained acceleration for vaccine development and considers learnings from the COVID pandemic and direct experience in addressing unmet medical needs. These reflections focus on (i) the importance of a cross-disciplinary framework of technical expectations ranging from target antigen identification to launch and life-cycle management; (ii) the use of prior platform knowledge across similar or products/vaccine types; (iii) the implementation of innovation and digital tools for fast development and innovative control strategies.

Funder

GSK

Publisher

MDPI AG

Subject

Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology

Link

https://www.mdpi.com/2076-393X/11/7/1153/pdf

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