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Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long Term Stability of Monoclonal Antibodies

Lin M Luis, Yuzhe Hu, Camellia Zamiri and Alavattam Sreedhara
PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2018.008581; DOI: https://doi.org/10.5731/pdajpst.2018.008581
Lin M Luis
Genentech
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  • For correspondence: luis.lin@gene.com
Yuzhe Hu
Genentech
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  • For correspondence: hu.yuzhe@gene.com
Camellia Zamiri
Genentech
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  • For correspondence: zamiri.camellia@gene.com
Alavattam Sreedhara
Genentech
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  • For correspondence: sreedhaa@gene.com
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Article Information

pdajpst.2018.008581
DOI 
https://doi.org/10.5731/pdajpst.2018.008581
PubMed 
29853610

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Received January 17, 2018
  • Accepted April 16, 2018
  • Published online May 31, 2018.

Article Versions

  • You are currently viewing a previous version of this article (May 31, 2018 - 12:56).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Lin M Luis (luis.lin@gene.com),
  2. Yuzhe Hu (hu.yuzhe@gene.com),
  3. Camellia Zamiri (zamiri.camellia@gene.com) and
  4. Alavattam Sreedhara1 (sreedhaa@gene.com)
  1. Genentech
  1. ↵* Corresponding author; email: sreedhaa@gene.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
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Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long Term Stability of Monoclonal Antibodies
Lin M Luis, Yuzhe Hu, Camellia Zamiri, Alavattam Sreedhara
PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2018.008581; DOI: 10.5731/pdajpst.2018.008581
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Keywords

  • ambient light exposure
  • drug product manufacturing
  • mild light
  • Monoclonal antibodies
  • Product quality

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Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long Term Stability of Monoclonal Antibodies
Lin M Luis, Yuzhe Hu, Camellia Zamiri, Alavattam Sreedhara
PDA Journal of Pharmaceutical Science and Technology May 2018, pdajpst.2018.008581; DOI: 10.5731/pdajpst.2018.008581

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