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Combined Genetic and Chemical Capsid Modifications of Adenovirus-Based Gene Transfer Vectors for Shielding and Targeting

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Published on: October 26, 2018

Algorithm-Based Liquid Formulation Development Including a DoE Concept Predicts Long-Term Viral Vector Stability.

Eva B Reinauer¹, Stella S Grosso¹, Stefan R Henz¹

¹LEUKOCARE AG, Department Research & Development, Am Klopferspitz 19, 82152, Martinsried, Munich, Germany.

Journal of Pharmaceutical Sciences

|November 6, 2019

Summary

This summary is machine-generated.

Amino acid formulations protect viral vectors like adenovirus 5 (Ad5) from degradation. This approach ensures Ad5 stability during long-term storage, outperforming standard formulations.

Keywords:

adenoviral vectors design of experiments excipient(s)formulation(s)gene delivery stabilization vaccine(s)viral vector(s)

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Utilizing the Antigen Capsid-Incorporation Strategy for the Development of Adenovirus Serotype 5-Vectored Vaccine Approaches

Published on: May 6, 2015

Area of Science:

Biotechnology
Biopharmaceutical Formulation
Viral Vector Stability

Background:

Amino acid-based formulations show promise in preventing stress-induced degradation of complex molecules, including monoclonal antibodies and viral vectors.
Adenovirus 5 (Ad5) is a model system for studying viral vector stability under various storage conditions.

Purpose of the Study:

To evaluate the efficacy of tailored amino acid formulations in protecting viral vectors, specifically Ad5, against thermal stress and during long-term liquid storage.
To develop a predictive model for viral vector stability using an algorithm-based approach and design of experiments.

Main Methods:

Utilized an excipient database for algorithm-based amino acid preselection.
Employed design of experiments (DoE) and a 37°C thermal challenge model to predict long-term storage stability of Ad5.
Analyzed Ad5 infectivity statistically to identify key amino acids influencing stability.
Tested Ad5 formulations with selected amino acids for infectivity after 24 months at 5°C.

Main Results:

Identified specific amino acids significantly enhancing Ad5 stability after 2-3 weeks of liquid storage at 37°C.
Ad5 formulations with selected amino acids maintained infectivity after 24 months at 5°C.
Standard viral vector formulations showed a 2-log reduction in infectivity after 3 months and complete loss after 18 months at 5°C.
Developed an optimized formulation that excluded MgCl2, which was previously considered essential for Ad5.

Conclusions:

Algorithm-based formulation development is effective for enhancing viral vector stability.
Tailored amino acid formulations provide superior protection for viral vectors during long-term liquid storage compared to standard methods.
The developed formulation strategy offers a robust and efficient approach for biopharmaceutical development.