PT  - JOURNAL ARTICLE
AU  - Luis, Lin M
AU  - Hu, Yuzhe
AU  - Zamiri, Camellia
AU  - Sreedhara, Alavattam
TI  - Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long Term Stability of Monoclonal Antibodies
AID  - 10.5731/pdajpst.2018.008581
DP  - 2018 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2018.008581
4099  - http://journal.pda.org/content/early/2018/05/25/pdajpst.2018.008581.short
4100  - http://journal.pda.org/content/early/2018/05/25/pdajpst.2018.008581.full
AB  - 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 drug product 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 drug product 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.