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 zekhwalithi eyinhloko (CQA) yomkhiqizo (CQA), i-pH kanye nokusebenza ngesikhathi senqubo yokukhiqiza, Ukuqinisekisa ukuhlinzeka ngamabhafa wekhwalithi eqinile nefanayo yezinqubo ezingezansi ukuze usize izinjongo zokukhululwa 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.