Incazelo Yomkhiqizo:

Inani elikhulu lama-buffer liyadingeka ohlelweni lokuhlanzwa komfula ongezansi lwe-biopharmaceuticals.Ukunemba nokukhiqizwa kabusha kwama-buffers kunomthelela omkhulu enqubweni yokuhlanza amaprotheni.Uhlelo lwe-inthanethi lokuhlanjululwa kanye nohlelo lokudosa ku-inthanethi lungahlanganisa amabhafa wengxenye eyodwa eyahlukene.Utshwala kamama kanye ne-diluent kuhlanganiswa ku-inthanethi ukuze kutholwe isixazululo okuhlosiwe.Umkhiqizo usekelwe olwazini lwesayensi, futhi ikhwalithi ivela kumqondo wokuklama (QbD).Ngokusebenzisa isikhathi sangempela se-inthanethi (Isikhathi Sangempela) sokuqapha nokulawula izinkomba zamakhemikhali ezimbili, izimfanelo eziyinhloko zekhwalithi (CQA) zomkhiqizo (CQA), i-pH kanye nokusebenza ngesikhathi senqubo yokukhiqiza, Ukuqinisekisa ukuhlinzeka ngamabhafa ezinzile futhi afanayo. ikhwalithi yezinqubo ezingezansi ukusiza izinjongo zokukhishwa kwepharamitha yezinkampani ze-biopharmaceutical.Inqubo yendabuko yokulungiselela uketshezi idinga inani elikhulu lamathangi kanye nevolumu enkulu.I-IVEN iletha amakhasimende ulwazi olusha lwezobuchwepheshe, inciphisa umkhondo we-buffer dosing esigabeni senqubo yokuhlanza, nokunciphisa izindleko zangaphambi kokutshalwa kwezimali kanye nokukhiqizwa kwangemva kokukhiqiza nokusebenza., Thuthukisa ukusebenza kahle kokukhiqiza, qinisekisa amapharamitha enqubo ebucayi (CPP) ye-buffer nokulandeleka kwayo, futhi ekugcineni uthuthukise ikhwalithi yemithi.