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

doi:10.5731/pdajpst.2018.008581

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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 July 2018, 72 (4) 393-403; DOI: https://doi.org/10.5731/pdajpst.2018.008581

Lin M. Luis

Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, South San Francisco, CA, USA

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Yuzhe Hu

Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, South San Francisco, CA, USA

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Camellia Zamiri

Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, South San Francisco, CA, USA

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Alavattam Sreedhara

Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, South San Francisco, CA, USA

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For correspondence: alavattam.sreedhara@gene.com

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vol. 72 no. 4 393-403

DOI

https://doi.org/10.5731/pdajpst.2018.008581

PubMed

29853610

Published By

Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

History

Published online August 9, 2018.

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previous version (May 31, 2018 - 12:56).
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Lin M. Luis,
Yuzhe Hu,
Camellia Zamiri and
Alavattam Sreedhara*

Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, South San Francisco, CA, USA

↵* Corresponding Author: Late Stage Pharmaceutical Development, Genentech Inc., a Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080, USA. Telephone: 650-467-8488; e-mail: alavattam.sreedhara{at}gene.com

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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 Jul 2018, 72 (4) 393-403; DOI: 10.5731/pdajpst.2018.008581

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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 Jul 2018, 72 (4) 393-403; DOI: 10.5731/pdajpst.2018.008581

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