title: ÐÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ðµ Ð²Ð»Ð¸ÑÐ½Ð¸Ñ ÐºÐ¾ÑÐ°ÐºÑÐ¾ÑÐ¾Ð² ÑÐµÑÐ¼ÐµÐ½ÑÐ¾Ð² Ð¸ Ð¿ÑÐµÐ´ÑÐµÑÑÐ²ÐµÐ½Ð½Ð¸ÐºÐ¾Ð² ÑÑÐ±ÑÑÑÐ°ÑÐ¾Ð²-Ð´Ð¾Ð½Ð¾ÑÐ¾Ð² Ð½Ð° Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG Ð½Ð° ÑÑÐ°Ð´Ð¸Ð¸ ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ°
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð±Ð°ÐºÐ°Ð»Ð°Ð²ÑÐ°
titleType: Subtitle
title: Study of the effect of enzyme cofactors and donor-substrates precursors on the N-glycosylation profile of IgG monoclonal antibodies during the producer cultivation
Creators: name: Ð¯ÐºÐ¾Ð²Ð»ÐµÐ², ÐÐ»ÐµÐºÑÐ°Ð½Ð´Ñ
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2024
Subjects: Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÐµ Ð°Ð½ÑÐ¸ÑÐµÐ»Ð°
N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ðµ
ÐºÐ¾ÑÐ°ÐºÑÐ¾ÑÑ
ÑÑÐ±ÑÑÑÐ°ÑÑ-Ð´Ð¾Ð½Ð¾ÑÑ
Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½ÑÐµ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÑ
monoclonal antibodies
N-glycosylation
cofactors
substrates-donor
biosimilar drugs

description: ÐÐ°Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¿Ð¾ÑÐ²ÑÑÐµÐ½Ð° Ð½Ð°Ð¿ÑÐ°Ð²Ð»ÐµÐ½Ð½Ð¾Ð¹ Ð¼Ð¾Ð´ÑÐ»ÑÑÐ¸Ð¸ Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ ÑÐµÑÐ°Ð¿ÐµÐ²ÑÐ¸ÑÐµÑÐºÐ¸Ñ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG Ð½Ð° ÑÑÐ°Ð´Ð¸Ð¸ ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ¾Ð², Ð¿Ð¾ÑÑÐµÐ´ÑÑÐ²Ð¾Ð¼ Ð²ÐºÐ»ÑÑÐµÐ½Ð¸Ñ Ð² ÑÐ¾ÑÑÐ°Ð² Ð¿Ð¸ÑÐ°ÑÐµÐ»ÑÐ½ÑÑ ÑÑÐµÐ´ Ð¸ Ð´Ð¾Ð±Ð°Ð²Ð¾Ðº ÐºÐ¾ÑÐ°ÐºÑÐ¾ÑÐ¾Ð² ÑÐµÑÐ¼ÐµÐ½ÑÐ¾Ð² N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ, Ð¿ÑÐµÐ´ÑÑÐ°Ð²Ð»ÐµÐ½Ð½ÑÑ Ð¸Ð¾Ð½Ð°Ð¼Ð¸ Ð¼ÐµÑÐ°Ð»Ð»Ð¾Ð², Ð¸ Ð¿ÑÐµÐ´ÑÐµÑÑÐ²ÐµÐ½Ð½Ð¸ÐºÐ¾Ð² ÑÑÐ±ÑÑÑÐ°ÑÐ¾Ð²-Ð´Ð¾Ð½Ð¾ÑÐ¾Ð² ÑÐµÐ°ÐºÑÐ¸Ð¹ Ð±Ð¸Ð¾ÑÐ¸Ð½ÑÐµÐ·Ð° N-Ð³Ð»Ð¸ÐºÐ°Ð½Ð¾Ð², Ð¿ÑÐµÐ´ÑÑÐ°Ð²Ð»ÐµÐ½Ð½ÑÑ Ð½ÑÐºÐ»ÐµÐ¾Ð·Ð¸Ð´Ð°Ð¼Ð¸ Ð¸ Ð¼Ð¾Ð½Ð¾ÑÐ°ÑÐ°ÑÐ¸Ð´Ð°Ð¼Ð¸. ÐÐ°Ð´Ð°ÑÐ¸, ÐºÐ¾ÑÐ¾ÑÑÐµ ÑÐµÑÐ°Ð»Ð¸ÑÑ Ð² ÑÐ¾Ð´Ðµ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ: - Ð¾Ð¿Ð¸ÑÐ°ÑÑ ÑÑÑÐ¾ÐµÐ½Ð¸Ðµ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG, ÑÐ¾Ð²ÑÐµÐ¼ÐµÐ½Ð½ÑÐµ Ð¿Ð¾Ð´ÑÐ¾Ð´Ñ Ðº Ð¸Ñ Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ñ, Ð¿ÑÐ¾ÑÐµÑÑ ÑÐ¾ÑÐ¼Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ, ÐµÐ³Ð¾ Ð±Ð¸Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÑÑ ÑÐ¾Ð»Ñ Ð¸ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¸Ðµ Ð¼ÐµÑÐ¾Ð´Ñ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ; - Ð¾Ð¿ÑÐµÐ´ÐµÐ»Ð¸ÑÑ Ð¿ÐµÑÐµÑÐµÐ½Ñ Ð¸ Ð´Ð¸Ð°Ð¿Ð°Ð·Ð¾Ð½ ÐºÐ¾Ð½ÑÐµÐ½ÑÑÐ°ÑÐ¸Ð¹ ÐºÐ¾Ð¼Ð¿Ð¾Ð½ÐµÐ½ÑÐ¾Ð², ÑÐ¿Ð¾ÑÐ¾Ð±Ð½ÑÑ, ÑÐ¾Ð³Ð»Ð°ÑÐ½Ð¾ Ð»Ð¸ÑÐµÑÐ°ÑÑÑÐ½ÑÐ¼ Ð´Ð°Ð½Ð½ÑÐ¼, Ð½Ð°Ð¿ÑÐ°Ð²Ð»ÐµÐ½Ð¾ Ð¿Ð¾Ð²Ð»Ð¸ÑÑÑ Ð½Ð° Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG; - ÑÐºÑÐ¿ÐµÑÐ¸Ð¼ÐµÐ½ÑÐ°Ð»ÑÐ½Ð¾ Ð¾Ð¿ÑÐµÐ´ÐµÐ»Ð¸ÑÑ Ð²Ð»Ð¸ÑÐ½Ð¸Ðµ Ð¸ÑÑÐ»ÐµÐ´ÑÐµÐ¼ÑÑ ÐºÐ¾Ð¼Ð¿Ð¾Ð½ÐµÐ½ÑÐ¾Ð² Ð½Ð° Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð¸ Ð±Ð¸Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÑÑ Ð°ÐºÑÐ¸Ð²Ð½Ð¾ÑÑÑ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÑ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG1 ACD-20HMAB, Ð° ÑÐ°ÐºÐ¶Ðµ ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¸Ðµ ÑÐ°ÑÐ°ÐºÑÐµÑÐ¸ÑÑÐ¸ÐºÐ¸ Ð¿ÑÐ¾ÑÐµÑÑÐ° ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ; - ÑÐºÑÐ¿ÐµÑÐ¸Ð¼ÐµÐ½ÑÐ°Ð»ÑÐ½Ð¾ Ð¾Ð¿ÑÐµÐ´ÐµÐ»Ð¸ÑÑ Ð´Ð¸Ð°Ð¿Ð°Ð·Ð¾Ð½ Ð±Ð¸Ð¾Ð¿Ð¾Ð´Ð¾Ð±Ð¸Ñ Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÑ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG1 ACD-20HMAB; - Ð¾ÑÐµÐ½Ð¸ÑÑ Ð¿ÑÐ¸Ð¼ÐµÐ½Ð¸Ð¼Ð¾ÑÑÑ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸Ñ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð½ÑÑ ÐºÐ¾Ð¼Ð¿Ð¾Ð½ÐµÐ½ÑÐ¾Ð² Ð² ÐºÐ¾Ð½ÑÐµÐºÑÑÐµ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÑ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ÐºÐ»Ð°ÑÑÐ° IgG1 ACD-20HMAB. ÐÐ±ÑÐµÐºÑ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ â ÐºÐ»ÐµÑÐ¾ÑÐ½Ð°Ñ Ð»Ð¸Ð½Ð¸Ñ CHO-K1, ÑÐºÑÐ¿ÑÐµÑÑÐ¸ÑÑÑÑÐ°Ñ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÐµ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÐµ Ð°Ð½ÑÐ¸ÑÐµÐ»Ð° ACD-20HMAB. Ð Ð°Ð±Ð¾ÑÐ° Ð²ÑÐ¿Ð¾Ð»Ð½ÐµÐ½Ð° Ð½Ð° Ð±Ð°Ð·Ðµ Ð»Ð°Ð±Ð¾ÑÐ°ÑÐ¾ÑÐ¸Ð¸ Ð¿Ð¾ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐµ Ð±Ð¸Ð¾ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¸Ñ Ð¿ÑÐ¾ÑÐµÑÑÐ¾Ð² ÐÐ Â«Ð -Ð¤Ð°ÑÐ¼Â», Ð³. Ð¯ÑÐ¾ÑÐ»Ð°Ð²Ð»Ñ. ÐÑÐµÐ´Ð¼ÐµÑÐ¾Ð¼ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ Ð±ÑÐ»Ð¾ Ð¸Ð·Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½ÑÑ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÑ Ð¼Ð¾Ð½Ð¾ÐºÐ»Ð¾Ð½Ð°Ð»ÑÐ½ÑÑ Ð°Ð½ÑÐ¸ÑÐµÐ» ACD-20HMAB Ð² Ð¾ÑÐ²ÐµÑ Ð½Ð° ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ðµ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ° Ð² Ð¿ÑÐ¸ÑÑÑÑÑÐ²Ð¸Ð¸ ÐºÐ¾ÑÐ°ÐºÑÐ¾ÑÐ¾Ð² ÑÐµÑÐ¼ÐµÐ½ÑÐ¾Ð² Ð¸ Ð¿ÑÐµÐ´ÑÐµÑÑÐ²ÐµÐ½Ð½Ð¸ÐºÐ¾Ð² ÑÑÐ±ÑÑÑÐ°ÑÐ¾Ð²-Ð´Ð¾Ð½Ð¾ÑÐ¾Ð². Ð¢Ð°ÐºÐ¶Ðµ, Ð¾ÑÐµÐ½Ð¸Ð²Ð°Ð»Ð¾ÑÑ Ð²Ð»Ð¸ÑÐ½Ð¸Ñ Ð¸ÑÑÐ»ÐµÐ´ÑÐµÐ¼ÑÑ ÐºÐ¾Ð¼Ð¿Ð¾Ð½ÐµÐ½ÑÐ¾Ð² Ð¿ÑÐ¾Ð´ÑÐºÑÐ¸Ð²Ð½Ð¾ÑÑÑ Ð¸ ÑÐ¾ÑÑÐ¾Ð²ÑÐµ ÑÐ°ÑÐ°ÐºÑÐµÑÐ¸ÑÑÐ¸ÐºÐ¸ ÐºÑÐ»ÑÑÑÑÑ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ°. Ð ÑÐ¾Ð´Ðµ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ ÑÑÑÐ°Ð½Ð¾Ð²Ð»ÐµÐ½Ð¾, ÑÑÐ¾ ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ðµ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ° Ð² Ð¿ÑÐ¸ÑÑÑÑÑÐ²Ð¸Ð¸ Mn2+, Ð³Ð°Ð»Ð°ÐºÑÐ¾Ð·Ñ, L-ÑÑÐºÐ¾Ð·Ñ, N-Ð°ÑÐµÑÐ¸Ð»-D-Ð³Ð»ÑÐºÐ¾Ð·Ð°Ð¼Ð¸Ð½Ð°, D-Ð³Ð°Ð»Ð°ÐºÑÐ¾Ð·Ñ Ð¸ ÑÑÐ¸Ð´Ð¸Ð½Ð° ÑÐ¿Ð¾ÑÐ¾Ð±Ð½Ð¾ Ð¿ÑÐ¸Ð²ÐµÑÑÐ¸ Ðº Ð½Ð°Ð¿ÑÐ°Ð²Ð»ÐµÐ½Ð½ÑÐ¼ Ð¸Ð·Ð¼ÐµÐ½ÐµÐ½Ð¸ÑÐ¼ Ð² Ð¿ÑÐ¾ÑÐ¸Ð»Ðµ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ ÑÐµÐ»ÐµÐ²Ð¾Ð³Ð¾ Ð¿ÑÐ¾Ð´ÑÐºÑÐ°. ÐÑÐ¸ ÑÑÐ¾Ð¼ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ ÑÑÐ¸Ð´Ð¸Ð½Ð° Ð¾Ð³ÑÐ°Ð½Ð¸ÑÐµÐ½Ð¾ Ð½ÐµÐ³Ð°ÑÐ¸Ð²Ð½ÑÐ¼ Ð²Ð»Ð¸ÑÐ½Ð¸ÐµÐ¼ Ð½Ð° Ð¿ÑÐ¾Ð´ÑÐºÑÐ¸Ð²Ð½Ð¾ÑÑÑ ÐºÑÐ»ÑÑÑÑÑ Ð¿ÑÐ¾Ð´ÑÑÐµÐ½ÑÐ° Ð² ÑÐ¾ Ð²ÑÐµÐ¼Ñ, ÐºÐ°Ðº Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ D-Ð³Ð°Ð»Ð°ÐºÑÐ¾Ð·Ñ, Ð½Ð°Ð¿ÑÐ¾ÑÐ¸Ð², Ð¿Ð¾Ð»Ð¾Ð¶Ð¸ÑÐµÐ»ÑÐ½Ð¾ Ð¿Ð¾Ð²Ð»Ð¸ÑÐ»Ð¾ Ð½Ð° ÑÐ¾Ð´ÐµÑÐ¶Ð°Ð½Ð¸Ðµ ÑÐµÐ»ÐµÐ²Ð¾Ð³Ð¾ Ð¿ÑÐ¾Ð´ÑÐºÑÐ° Ð² ÐºÑÐ»ÑÑÑÑÐ°Ð»ÑÐ½Ð¾Ð¹ Ð¶Ð¸Ð´ÐºÐ¾ÑÑÐ¸. Ð¡Ð¾Ð²Ð¼ÐµÑÑÐ½Ð¾Ðµ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ L-ÑÑÐºÐ¾Ð·Ñ Ð¸ Mn2+ Ð¿Ð¾Ð·Ð²Ð¾Ð»Ð¸Ð»Ð¾ Ð¿ÑÐ¸Ð²ÐµÑÑÐ¸ Ð¿ÑÐ¾ÑÐ¸Ð»Ñ N-Ð³Ð»Ð¸ÐºÐ¾Ð·Ð¸Ð»Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½ÑÑ ÐÐÐ¢ ACD-20HMAB Ð² ÑÐ¾Ð¾ÑÐ²ÐµÑÑÑÐ²Ð¸Ðµ Ð´Ð¸Ð°Ð¿Ð°Ð·Ð¾Ð½Ñ Ð±Ð¸Ð¾Ð¿Ð¾Ð´Ð¾Ð±Ð¸Ñ Ð¸, ÐºÐ°Ðº ÑÐ»ÐµÐ´ÑÑÐ²Ð¸Ðµ, Ð´Ð¾ÑÑÐ¸ÑÑ ÑÐ¾Ð¿Ð¾ÑÑÐ°Ð²Ð¸Ð¼Ð¾Ð¹ Ñ Ð¾ÑÐ¸Ð³Ð¸Ð½Ð°Ð»ÑÐ½ÑÐ¼ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð¼ Ð¾ÑÐ½Ð¾ÑÐ¸ÑÐµÐ»ÑÐ½Ð¾Ð¹ Ð±Ð¸Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð¹ Ð°ÐºÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸, Ð¿ÑÐ¸ ÑÑÐ¾Ð¼ Ð½Ðµ Ð¾ÐºÐ°Ð·Ð°Ð² Ð½ÐµÐ³Ð°ÑÐ¸Ð²Ð½Ð¾Ð³Ð¾ Ð²Ð»Ð¸ÑÐ½Ð¸Ñ Ð½Ð° ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¸Ðµ ÑÐ°ÑÐ°ÐºÑÐµÑÐ¸ÑÑÐ¸ÐºÐ¸ Ð¿ÑÐ¾ÑÐµÑÑÐ° ÐºÑÐ»ÑÑÐ¸Ð²Ð¸ÑÐ¾Ð²Ð°Ð½Ð¸Ñ, ÑÑÐ¾ Ð´ÐµÐ»Ð°ÐµÑ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ Ð´Ð°Ð½Ð½ÑÑ ÐºÐ¾Ð¼Ð¿Ð¾Ð½ÐµÐ½ÑÐ¾Ð² Ð¿ÐµÑÑÐ¿ÐµÐºÑÐ¸Ð²Ð½ÑÐ¼ Ð¸Ð½ÑÑÑÑÐ¼ÐµÐ½ÑÐ¾Ð¼ Ð² ÐºÐ¾Ð½ÑÐµÐºÑÑÐµ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ¸ Ð±Ð¸Ð¾Ð°Ð½Ð°Ð»Ð¾Ð³Ð¸ÑÐ½ÑÑ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ¾Ð² Ð½Ð° Ð¾ÑÐ½Ð¾Ð²Ðµ ÐÐÐ¢ ÐºÐ»Ð°ÑÑÐ° IgG.
description: This work is dedicated to the controlled modulation of the N-glycosylation pattern of therapeutic monoclonal antibodies belonging to the IgG class, during the cultivation of producer cells, by including in the composition of basal and feed media cofactors of N-glycosylation enzymes, such as metal ions, and precursors of donor-substrates of N-glycan biosynthesis reactions, such as nucleosides and monosaccharides. The following tasks had been solved during of study: - to describe the structure of IgG class monoclonal antibodies, modern approaches to their production, the process of forming the N-glycosylation profile, its biological role and analytical control methods; - to determine the set and the concentrations range of components that, according to the literature scientific literature data, can directly affect the N-glycosylation profile of IgG MABs; - to determine the effect of the studied components on the N-glycosylation profile and on biological activity of the biosimilar drug based on recombinant monoclonal antibodies IgG1 ACD-20HMABs, as well as to determine the technological characteristics of the cultivation process; - to experimentally determine the range of biosimilarity of the N-glycosylation profile for the biosimilar drug based on recombinant IgG1 ACD-20HMABs; - to evaluate the applicability of the studied components use for the development of the biosimilar drug based on recombinant IgG1 ACD-20HMABs. The object of the study is the CHOâK1 cell line expressing the recombinant ACD-20HMABs. The work was carried out at the R&amp;D laboratory for the development of biotechnological processes, JSC R-Pharm, Yaroslavl city. The subject of the study was a change in the N-glycosylation profile of biosimilar recombinant ACD-20HMABs in response to the producer cultivation in the presence of enzyme cofactors and donor substrates precursor. In addition, the effects on productivity and growth characteristics of the producers culture were evaluated. The study found that the producer cultivation in the presence of Mn2+, galactose, L-fucose, N-acetyl-D-glucosamine, D-galactose and uridine could lead to directed changes in the N-glycosylation profile of the target product. At the same time, the use of uridine had a negative effect on the productivity, while the use of D-galactose, on the contrary, had a positive effect on the target product content in the culture medium. The combined use of L-fucose and Mn2+ made it possible to bring the N-glycosylation profile of biosimilar ACD-20HMAB into line with the range of biosimilarity and, as a result, to achieve relative biological activity comparable to that of the original drug, without affecting adversely affecting the technological characteristics of the cultivation process, which makes their use promising tools for the development of biosimilar drugs based on IgG MABs. To write the scientific literary review, the following databases were used: eLIBRARY.RU, SCOPUS, NCBI. Statistical processing of experimental data was carried out using software: Microsoft Excel, Empower, SoftMax Pro PLA 3.0.