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Research ArticleResearch

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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Abstract

Monoclonal antibodies (mAbs) are exposed to light during drug product (DP) manufacturing, and the acceptable levels of light exposure needs to be determined based on the impact on product quality. In this study, a mild and more representative light model consisting of ambient light instead of stress light as prescribed by ICH Q1B was used to evaluate the impact of light exposure on mAb DP quality. The immediate effect of ambient light exposure on protein DP quality was determined to be dependent on the amount of light exposure rather than light intensity (up to 5000 lux). The impact on quality of mAbs is product specific due to their differences in light sensitivity, in which mAb II shows larger increases in IEC basic variants and larger decreases in SEC monomer when compared to mAb I after 0.24 million lux hours of light exposure. The acceptable ambient light exposure for mAb II DP manufacturing was determined to be 0.13 million lux hours, in which no impact on product quality was observed after the short-term light exposure. Additionally, real-time storage (5 °C) of the DP after the prescribed ambient light exposure showed no impact to various product quality attributes. The light model used in this study is capable of determining the acceptable amount of ambient light exposure for mAbs, especially during DP manufacturing processes.

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PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
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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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