Ukuhlanjululwa kwi-Intanethi kunye nezixhobo zokudosa kwi-intanethi
Isixa esikhulu se-buffers siyafuneka kwinkqubo yokucoca ezantsi kwe-biopharmaceuticals. Ukuchaneka kunye nokuveliswa kwakhona kwee-buffers kunempembelelo enkulu kwinkqubo yokucoca iprotheni. I-intanethi ye-dilution kunye nenkqubo yokudosa kwi-intanethi inokudibanisa iintlobo ngeentlobo ze-buffers zecandelo elinye. Utywala lukamama kunye ne-diluent zidityaniswe kwi-intanethi ukufumana isisombululo esijoliswe kuyo. Imveliso isekelwe kulwazi lwesayensi, kwaye umgangatho uvela kwingcamango yoyilo (QbD). Ngokusebenzisa ixesha langempela kwi-intanethi (Eyenyani ngexesha) esweni kunye nokulawulwa kwezikhombisi zemichiza ezibini, iimpawu ezingundoqo zomgangatho (CQA) wemveliso (CQA), i-pH kunye ne-conductivity ngexesha lenkqubo yokuvelisa, Ukuqinisekisa ukubonelela nge-buffers yomgangatho ozinzileyo kunye nomgangatho ofanayo kwiinkqubo ezisezantsi zokuncedisa kwiinkampani ze-biopharmaceutical 'injongo yokukhululwa kweparameter. Inkqubo yokulungiselela ulwelo lwemveli ifuna inani elikhulu lamatanki kunye nomthamo omkhulu. I-VEN izisa abathengi amava obugcisa obutsha, ukunciphisa unyawo lwe-buffer dosing kwinqanaba lenkqubo yokucoca, kunye nokunciphisa utyalo-mali lwangaphambili kunye neendleko zasemva kokuveliswa kunye nokusebenza. , Ukuphucula ukusebenza kakuhle kwemveliso, qinisekisa iiparameters zenkqubo ebalulekileyo (CPP) ye-buffer kunye nokulandeleka kwayo, kwaye ekugqibeleni uphucule umgangatho wamayeza.
