Process optimization for the rapid production of adenoviral vectors for clinical trials in a disposable bioreactor system

Process optimization for the rapid production of adenoviral vectors for clinical trials in a... Recombinant adenoviral (Ad) vectors are highly efficient gene transfer vectors widely used in vaccine development and immu- notherapy. To promote the industrial application of Ad vectors, studies focusing on reducing the cost of manufacturing, short- ening the preclinical research period, and improving the quality of products are needed. Here, we describe a highly efficient and economical process for producing Ad vector in a novel, single-use bioreactor system suitable for clinical trials. A mini-bioreactor was used for parameter optimization and development of medium replacement protocols for Ad5-GFP production before scale- up. HEK293 cell culture and virus infection were monitored in a disposable AmProtein Current Perfusion Bioreactor and Bioflo310 bioreactor using optimized parameters and medium replacement protocols. The total cell number increased from 9 10 15 2.0 × 10 to 3.2 × 10 after 6 days of culture. The total number of viral particles obtained in a single batch was 1.2 × 10 . These results demonstrate the efficiency and suitability of this system for Ad vector production for research and GMP applications. . . . Keywords Adenoviral vector Disposable bioreactor HEK293 cells Process optimization Introduction shortening the preclinical research period, and improving product quality. The HEK293 cell line is widely http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Applied Microbiology and Biotechnology Springer Journals

Process optimization for the rapid production of adenoviral vectors for clinical trials in a disposable bioreactor system

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Publisher
Springer Berlin Heidelberg
Copyright
Copyright © 2018 by Springer-Verlag GmbH Germany, part of Springer Nature
Subject
Life Sciences; Microbiology; Microbial Genetics and Genomics; Biotechnology
ISSN
0175-7598
eISSN
1432-0614
D.O.I.
10.1007/s00253-018-9091-5
Publisher site
See Article on Publisher Site

Abstract

Recombinant adenoviral (Ad) vectors are highly efficient gene transfer vectors widely used in vaccine development and immu- notherapy. To promote the industrial application of Ad vectors, studies focusing on reducing the cost of manufacturing, short- ening the preclinical research period, and improving the quality of products are needed. Here, we describe a highly efficient and economical process for producing Ad vector in a novel, single-use bioreactor system suitable for clinical trials. A mini-bioreactor was used for parameter optimization and development of medium replacement protocols for Ad5-GFP production before scale- up. HEK293 cell culture and virus infection were monitored in a disposable AmProtein Current Perfusion Bioreactor and Bioflo310 bioreactor using optimized parameters and medium replacement protocols. The total cell number increased from 9 10 15 2.0 × 10 to 3.2 × 10 after 6 days of culture. The total number of viral particles obtained in a single batch was 1.2 × 10 . These results demonstrate the efficiency and suitability of this system for Ad vector production for research and GMP applications. . . . Keywords Adenoviral vector Disposable bioreactor HEK293 cells Process optimization Introduction shortening the preclinical research period, and improving product quality. The HEK293 cell line is widely

Journal

Applied Microbiology and BiotechnologySpringer Journals

Published: Jun 2, 2018

References

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