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

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

Maria Monica Castellanos  1 , Hervé Gressard  2 , Xiangming Li  3 , Claudia Magagnoli  4 , Alessio Moriconi  5 , Daniela Stranges  5 , Laurent Strodiot  6 , Monica Tello Soto  7 , Magdalena Zwierzyna  8 , Cristiana Campa  9
Affiliations
Review

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

Maria Monica Castellanos et al. Vaccines (Basel). .

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.

Keywords: CMC acceleration; modeling and digital tools; pandemic preparedness; vaccine platform.

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Conflict of interest statement

The authors declare no conflict of interest. At the time of manuscript publication, Maria Monica Castellanos is an AstraZeneca employee. Cristiana Campa, Alessio Moriconi, Magdalena Zwierzyna, Hervé Gressard, Laurent Strodiot, Claudia Magagnoli and Monica Tello Soto report ownership of GSK shares.

Figures

Figure 1
Figure 1
Strategic pillars for pandemic preparedness and acceleration.
Figure 2
Figure 2
Enablers associated with pandemic preparedness and sustained acceleration (green color: related to end-to-end adaptive framework; yellow color: related to prior and platform knowledge; grey color: related to digital and innovation).
Figure 3
Figure 3
Graphical summary of analytical platformization opportunities in the context of analytical QbD framework, based on the cited literature.
Figure 4
Figure 4
Stability data at 5 °C, 25 °C and 37 °C up to 6 months (filled circles) were used to model the potency loss for each temperature over time represented by the dashed line and its 95% prediction interval represented by solid lines; the data at 5 °C after 6 months (empty circles) are used to assess the quality of the model.
Figure 5
Figure 5
Evolution of cell line development (CLD) workflow for CHO protein vaccines.
Figure 6
Figure 6
Innovations in expression systems enable dual-cycle development strategies. GLP Tox: Good-Laboratory-Practices toxicity batch. FIH: First in human clinical trial.
Figure 7
Figure 7
Continuous formulation connected to a filling line.
See this image and copyright information in PMC

References

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