Biologik va biotexnologik dorilarning sifat hamda soflik nazorati
Kalit so'zlar:
biologik dori vositalari, biotexnologiya, biofarmatsevtika, sifat nazorati, soflik darajasi, monoklonal aksiladdalar, rekombinant oqsillar, vaksinalar, gen va, hujayra terapiyasi, biologik faollik (potensiya), aralashmalar (impurities), hujayra oqsillari qoldigʻi (HCP), hujayra DNKsi qoldigʻi (HCD), molekulyar agregatsiya, destruksiya mahsulotlari, gomogenlik (bir jinslilik), bioassaye (biologik testlash), xromatografik tahlil (HPLC/UPLC), kapillyar elektroforez, mass-spektrometriya, validatsiya, ICH Q6B standartlari, GMP talablari, farmakopeya standartlari, preparat barqarorligiAnnotatsiya
Ushbu ishda biologik va biotexnologik dori vositalarining — jumladan, monoklonal aksiladdalar, rekombinant oqsillar, vaksinalar hamda gen terapiyasi preparatlarining sifat koʻrsatkichlari va soflik darajasini nazorat qilish masalalari tahlil qilinadi. Biologik preparatlar tirik hujayra tizimlarida sintez qilingani sababli, ularning tarkibi va makromolekulyar tuzilishi murakkab boʻlib, yuqori darajadagi gomogenlik hamda barqarorlikni talab etadi. Tadqiqotda dori vositalarining faolligi va xavfsizligiga ta'sir etuvchi asosiy omillar, xususan, hujayra qoldiqlari (DNK va oqsillar), agregatlar hamda destruksiya mahsulotlari kabi aralashmalarni aniqlash va me'yorlash usullari yoritilgan. Shuningdek, yuqori samarali suyuqlik xromatografiyasi (HPLC), kapillyar elektroforez va mass-spektrometriya kabi zamonaviy analitik metodlarning oʻrni va ularni ICH (Q6B, Q5A-E) xalqaro standartlari talablariga muvofiq qoʻllash prinsiplari koʻrsatib berilgan. Olingan xulosalar biotexnologik mahsulotlarni ishlab chiqarish jarayonida samaradorlik va xavfsizlik kafolatini ta'minlash uchun sifat nazorati tizimini toʻgʻri yoʻlga qoʻyish zarurligini asoslab beradi.
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