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用于疫苗开发以加速进程和增强大流行防范能力的CMC策略与先进技术

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

作者信息

Castellanos Maria Monica, Gressard Hervé, Li Xiangming, Magagnoli Claudia, Moriconi Alessio, Stranges Daniela, Strodiot Laurent, Tello Soto Monica, Zwierzyna Magdalena, Campa Cristiana

机构信息

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

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

出版信息

Vaccines (Basel). 2023 Jun 26;11(7):1153. doi: 10.3390/vaccines11071153.

DOI:10.3390/vaccines11071153
PMID:37514969
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10386492/
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.

摘要

本综述报告了加速/应对大流行及防范的关键推动因素概述，涵盖了化学、制造和控制（CMC）策略以及疫苗开发中的技术创新。文中分享了关于实施障碍以及推动疫苗开发持续加速的机会的思考，并探讨了从新冠疫情中吸取的经验教训以及满足未满足医疗需求的直接经验。这些思考聚焦于：（i）从靶点抗原识别到上市及生命周期管理的跨学科技术期望框架的重要性；（ii）在相似产品/疫苗类型中运用先前的平台知识；（iii）为快速开发和创新控制策略实施创新及数字工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/2f241a7384fb/vaccines-11-01153-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/0c94d75498a1/vaccines-11-01153-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/9de44e7f4d4e/vaccines-11-01153-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/203a40f4021f/vaccines-11-01153-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/369f6cc0be6f/vaccines-11-01153-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/cf9ceed97ef7/vaccines-11-01153-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/8efb8a3b3247/vaccines-11-01153-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/2f241a7384fb/vaccines-11-01153-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/0c94d75498a1/vaccines-11-01153-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/9de44e7f4d4e/vaccines-11-01153-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/203a40f4021f/vaccines-11-01153-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/369f6cc0be6f/vaccines-11-01153-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/cf9ceed97ef7/vaccines-11-01153-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/8efb8a3b3247/vaccines-11-01153-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824c/10386492/2f241a7384fb/vaccines-11-01153-g007.jpg

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

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[1]
Fast-Tracking Vaccine Manufacturing: CEPI's Rapid Response Framework for the 100 Days Mission.

Vaccines (Basel). 2025-8-11

[2]
Artificial Intelligence-Driven Strategies for Targeted Delivery and Enhanced Stability of RNA-Based Lipid Nanoparticle Cancer Vaccines.

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[3]
Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.

Vaccines (Basel). 2024-12-20

[4]
Impact of accelerated review policy on portfolio planning of vaccine companies.

Front Public Health. 2024-12-9

[5]
Stability Preparedness: The Not-So-Cold Case for Innovations in Vaccine Stability Modelling and Product Release.

Vaccines (Basel). 2024-9-1

[6]
Unlocking the Therapeutic Applicability of LNP-mRNA: Chemistry, Formulation, and Clinical Strategies.

Research (Wash D C). 2024-6-18

[7]
The Platform Technology Approach to mRNA Product Development and Regulation.

Vaccines (Basel). 2024-5-11

[8]
Digital Twin Fundamentals of mRNA Transcription in Variable Scale Toward Autonomous Operation.

ACS Omega. 2024-2-5

[9]
Engineered EVs with pathogen proteins: promising vaccine alternatives to LNP-mRNA vaccines.

J Biomed Sci. 2024-1-17

本文引用的文献

[1]
Algorithm for optimized mRNA design improves stability and immunogenicity.

Nature. 2023-9

[2]
Accelerated CMC workflows to enable speed to clinic in the COVID-19 era: A multi-company view from the biopharmaceutical industry.

Biotechnol Prog. 2023-3

[3]
An engineered T7 RNA polymerase that produces mRNA free of immunostimulatory byproducts.

Nat Biotechnol. 2023-4

[4]
The Storage and In-Use Stability of mRNA Vaccines and Therapeutics: Not A Cold Case.

J Pharm Sci. 2023-2

[5]
Microfluidic production of mRNA-loaded lipid nanoparticles for vaccine applications.

Expert Opin Drug Deliv. 2022-10

[6]
A robust defect detection method for syringe scale without positive samples.

Vis Comput. 2022-9-27

[7]
Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products.

Curr Opin Biotechnol. 2022-12

[8]
Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines.

AAPS J. 2022-9-27

[9]
Considerations for the chemistry, manufacturing and Controls (CMC) - quality package for COVID-19 vaccines- interim lessons learnt by the European medicines Agency (EMA).

Vaccine. 2022-9-9

[10]
Global impact of the first year of COVID-19 vaccination: a mathematical modelling study.

Lancet Infect Dis. 2022-9

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