Impact Factors in the Process Development for Therapeutic Antibodies

Xiaopei Cui; Xiangyang Zhu

doi:doi:10.11648/j.ijpc.20180402.11

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Impact Factors in the Process Development for Therapeutic Antibodies

Xiaopei Cui, Xiangyang Zhu

Received: 4 July 2018 Accepted: 26 July 2018 Published: 16 August 2018

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Abstract

The research and development of therapeutic antibodies in the world is rapidly rising in recent years. It is a huge challenge to obtain a robust process and achieve the consistency of consistent product quality, because most of the antibody drugs are produced from mammalian cells of which the production processes are long and complex. To develop a robust and high yield production process for a biotherapeutic, one needs to have a general consideration of entire R&D project working flow. First of all, it is necessary to start with a good drug candidate, which not only meets the requirement for both the effectiveness and drug safety, but also suits for manufacture. Then, the expression system and host cell line used for the product expression need to be determined based on availability and regulatory requirements. Cell line development needs to combine with early upstream and downstream process developments as well as product quality assessment. Once a suitable stable cell line is selected, the Master Cell Bank (MCB) and the Working Cell Bank (WCB) are established according to the regulatory requirements, and tested for growth, production stability and cellular safety. Finally, process optimization and scale-up production are carried out to obtain a consistent production. Upstream process development is mainly to optimize a variety of process parameters, including physical parameters, chemical parameters, metabolite levels, and feed strategy and foam control; downstream process development focuses on product quality, recovery rate, and cost efficiency. For scale-up production, enterprises need to make decisions whether to use traditional stainless steel system or the single-use disposable system based on demands on product market potential and available technical supports. In this review, combined with the development of new technologies in recent years and the authors’ personal working experience, the factors that need to be considered in process development are discussed.

DOI	10.11648/j.ijpc.20180402.11
Published in	International Journal of Pharmacy and Chemistry (Volume 4, Issue 2, March 2018)
Page(s)	16-22
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Therapeutic Antibody, Process Development, Quality Control

References

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Xiaopei Cui, Xiangyang Zhu. (2018). Impact Factors in the Process Development for Therapeutic Antibodies. International Journal of Pharmacy and Chemistry, 4(2), 16-22. https://doi.org/10.11648/j.ijpc.20180402.11

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Xiaopei Cui; Xiangyang Zhu. Impact Factors in the Process Development for Therapeutic Antibodies. Int. J. Pharm. Chem. 2018, 4(2), 16-22. doi: 10.11648/j.ijpc.20180402.11

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AMA Style

Xiaopei Cui, Xiangyang Zhu. Impact Factors in the Process Development for Therapeutic Antibodies. Int J Pharm Chem. 2018;4(2):16-22. doi: 10.11648/j.ijpc.20180402.11

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@article{10.11648/j.ijpc.20180402.11,
  author = {Xiaopei Cui and Xiangyang Zhu},
  title = {Impact Factors in the Process Development for Therapeutic Antibodies},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {4},
  number = {2},
  pages = {16-22},
  doi = {10.11648/j.ijpc.20180402.11},
  url = {https://doi.org/10.11648/j.ijpc.20180402.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20180402.11},
  abstract = {The research and development of therapeutic antibodies in the world is rapidly rising in recent years. It is a huge challenge to obtain a robust process and achieve the consistency of consistent product quality, because most of the antibody drugs are produced from mammalian cells of which the production processes are long and complex. To develop a robust and high yield production process for a biotherapeutic, one needs to have a general consideration of entire R&D project working flow. First of all, it is necessary to start with a good drug candidate, which not only meets the requirement for both the effectiveness and drug safety, but also suits for manufacture. Then, the expression system and host cell line used for the product expression need to be determined based on availability and regulatory requirements. Cell line development needs to combine with early upstream and downstream process developments as well as product quality assessment. Once a suitable stable cell line is selected, the Master Cell Bank (MCB) and the Working Cell Bank (WCB) are established according to the regulatory requirements, and tested for growth, production stability and cellular safety. Finally, process optimization and scale-up production are carried out to obtain a consistent production. Upstream process development is mainly to optimize a variety of process parameters, including physical parameters, chemical parameters, metabolite levels, and feed strategy and foam control; downstream process development focuses on product quality, recovery rate, and cost efficiency. For scale-up production, enterprises need to make decisions whether to use traditional stainless steel system or the single-use disposable system based on demands on product market potential and available technical supports. In this review, combined with the development of new technologies in recent years and the authors’ personal working experience, the factors that need to be considered in process development are discussed.},
 year = {2018}
}

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TY  - JOUR
T1  - Impact Factors in the Process Development for Therapeutic Antibodies
AU  - Xiaopei Cui
AU  - Xiangyang Zhu
Y1  - 2018/08/16
PY  - 2018
N1  - https://doi.org/10.11648/j.ijpc.20180402.11
DO  - 10.11648/j.ijpc.20180402.11
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 16
EP  - 22
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20180402.11
AB  - The research and development of therapeutic antibodies in the world is rapidly rising in recent years. It is a huge challenge to obtain a robust process and achieve the consistency of consistent product quality, because most of the antibody drugs are produced from mammalian cells of which the production processes are long and complex. To develop a robust and high yield production process for a biotherapeutic, one needs to have a general consideration of entire R&D project working flow. First of all, it is necessary to start with a good drug candidate, which not only meets the requirement for both the effectiveness and drug safety, but also suits for manufacture. Then, the expression system and host cell line used for the product expression need to be determined based on availability and regulatory requirements. Cell line development needs to combine with early upstream and downstream process developments as well as product quality assessment. Once a suitable stable cell line is selected, the Master Cell Bank (MCB) and the Working Cell Bank (WCB) are established according to the regulatory requirements, and tested for growth, production stability and cellular safety. Finally, process optimization and scale-up production are carried out to obtain a consistent production. Upstream process development is mainly to optimize a variety of process parameters, including physical parameters, chemical parameters, metabolite levels, and feed strategy and foam control; downstream process development focuses on product quality, recovery rate, and cost efficiency. For scale-up production, enterprises need to make decisions whether to use traditional stainless steel system or the single-use disposable system based on demands on product market potential and available technical supports. In this review, combined with the development of new technologies in recent years and the authors’ personal working experience, the factors that need to be considered in process development are discussed.
VL  - 4
IS  - 2
ER  -

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Author Information

Xiaopei Cui

Department of Process Development, Huabo Biopharma, Shanghai, China
Xiangyang Zhu

Department of Process Development, Huabo Biopharma, Shanghai, China

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Xiaopei Cui, Xiangyang Zhu. (2018). Impact Factors in the Process Development for Therapeutic Antibodies. International Journal of Pharmacy and Chemistry, 4(2), 16-22. https://doi.org/10.11648/j.ijpc.20180402.11

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ACS Style

Xiaopei Cui; Xiangyang Zhu. Impact Factors in the Process Development for Therapeutic Antibodies. Int. J. Pharm. Chem. 2018, 4(2), 16-22. doi: 10.11648/j.ijpc.20180402.11

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AMA Style

Xiaopei Cui, Xiangyang Zhu. Impact Factors in the Process Development for Therapeutic Antibodies. Int J Pharm Chem. 2018;4(2):16-22. doi: 10.11648/j.ijpc.20180402.11

Copy | Download

@article{10.11648/j.ijpc.20180402.11,
  author = {Xiaopei Cui and Xiangyang Zhu},
  title = {Impact Factors in the Process Development for Therapeutic Antibodies},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {4},
  number = {2},
  pages = {16-22},
  doi = {10.11648/j.ijpc.20180402.11},
  url = {https://doi.org/10.11648/j.ijpc.20180402.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20180402.11},
  abstract = {The research and development of therapeutic antibodies in the world is rapidly rising in recent years. It is a huge challenge to obtain a robust process and achieve the consistency of consistent product quality, because most of the antibody drugs are produced from mammalian cells of which the production processes are long and complex. To develop a robust and high yield production process for a biotherapeutic, one needs to have a general consideration of entire R&D project working flow. First of all, it is necessary to start with a good drug candidate, which not only meets the requirement for both the effectiveness and drug safety, but also suits for manufacture. Then, the expression system and host cell line used for the product expression need to be determined based on availability and regulatory requirements. Cell line development needs to combine with early upstream and downstream process developments as well as product quality assessment. Once a suitable stable cell line is selected, the Master Cell Bank (MCB) and the Working Cell Bank (WCB) are established according to the regulatory requirements, and tested for growth, production stability and cellular safety. Finally, process optimization and scale-up production are carried out to obtain a consistent production. Upstream process development is mainly to optimize a variety of process parameters, including physical parameters, chemical parameters, metabolite levels, and feed strategy and foam control; downstream process development focuses on product quality, recovery rate, and cost efficiency. For scale-up production, enterprises need to make decisions whether to use traditional stainless steel system or the single-use disposable system based on demands on product market potential and available technical supports. In this review, combined with the development of new technologies in recent years and the authors’ personal working experience, the factors that need to be considered in process development are discussed.},
 year = {2018}
}

Copy | Download

TY  - JOUR
T1  - Impact Factors in the Process Development for Therapeutic Antibodies
AU  - Xiaopei Cui
AU  - Xiangyang Zhu
Y1  - 2018/08/16
PY  - 2018
N1  - https://doi.org/10.11648/j.ijpc.20180402.11
DO  - 10.11648/j.ijpc.20180402.11
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 16
EP  - 22
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20180402.11
AB  - The research and development of therapeutic antibodies in the world is rapidly rising in recent years. It is a huge challenge to obtain a robust process and achieve the consistency of consistent product quality, because most of the antibody drugs are produced from mammalian cells of which the production processes are long and complex. To develop a robust and high yield production process for a biotherapeutic, one needs to have a general consideration of entire R&D project working flow. First of all, it is necessary to start with a good drug candidate, which not only meets the requirement for both the effectiveness and drug safety, but also suits for manufacture. Then, the expression system and host cell line used for the product expression need to be determined based on availability and regulatory requirements. Cell line development needs to combine with early upstream and downstream process developments as well as product quality assessment. Once a suitable stable cell line is selected, the Master Cell Bank (MCB) and the Working Cell Bank (WCB) are established according to the regulatory requirements, and tested for growth, production stability and cellular safety. Finally, process optimization and scale-up production are carried out to obtain a consistent production. Upstream process development is mainly to optimize a variety of process parameters, including physical parameters, chemical parameters, metabolite levels, and feed strategy and foam control; downstream process development focuses on product quality, recovery rate, and cost efficiency. For scale-up production, enterprises need to make decisions whether to use traditional stainless steel system or the single-use disposable system based on demands on product market potential and available technical supports. In this review, combined with the development of new technologies in recent years and the authors’ personal working experience, the factors that need to be considered in process development are discussed.
VL  - 4
IS  - 2
ER  -

Copy | Download