کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5858599 | 1562171 | 2014 | 6 صفحه PDF | دانلود رایگان |
- Prior to gd119, all maternal IgG2X plasma concentrations were BLQ (<25Â ng/mL).
- In 3/5 monkeys, maternal IgG2X remained BLQ throughout pregnancy.
- In 2/5 monkeys, maternal IgG2X reached â¼0.01% IvG dose after gd119 and 133.
- IgG2X was BLQ (<25Â ng/mL) in all fetal plasma samples.
- Male-mediated monoclonal antibody drug transfer via semen does not present a health risk in humans.
To assess the potential for male-mediated drug transfer to their female partner and/or developing conceptus, vaginal uptake of a monoclonal antibody (mAb) biotherapeutic was assessed in cynomolgus monkeys. A human IgG2 mAb (IgG2X; bound human and cynomolgus monkey neonatal Fc-receptor, FcRn, with similar high affinity) was administered intravaginally (IvG; 100Â mg/dose) to 5 pregnant cynomolgus monkeys biweekly from gestation day (gd) 21 to gd133. In all maternal samples collected before gd119, IgG2X plasma concentrations were below the limit of quantification (BLQ; <25Â ng/mL). After dosing on gd119 and 133, maternal IgG2X plasma concentrations remained BLQ in 3/5 monkeys and were very low in 2/5 (up to 116Â ng/mL; â¼0.01% of the IvG dose). IgG2X was BLQ in all fetal plasma samples. These data indicate that male-mediated mAb drug transfer via seminal fluid does not present a health risk to the female partner and is not bioavailable to the developing conceptus.
Journal: Reproductive Toxicology - Volume 48, September 2014, Pages 132-137