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Isicelo ku-Bioprocessing

Amaseli ezilwane ezincelisayo asetshenziswa kakhulu kuma-Biopharmaceuticals, njengamasosha omzimba, umgomo, ama-peptide nama-metabolites esibili akhiqizwa ngokucutshungulwa kwezinto eziphilayo ngamaseli ezincelisayo.Phakathi nayo yonke inqubo ukusuka ku-R&D yamasosha omzimba ukuya ekukhiqizweni, kunezinyathelo eziningi ezidingekayo zokwenza ukuhlola okusekelwe kumaseli ukuze kuhlolwe inqubo noma ukulawulwa kwekhwalithi.Okufana nokugcwala kwamaseli okuphelele nokusebenza kuzochaza isimo sesiko lamaseli.Kanye nokudluliswa kweseli, ukuhlobana kwe-antibody kunquma ezingeni leseli.Amathuluzi e-Countstar ayi-cytometry esekelwe esithombeni, angasiza ukuqapha kusukela ku-R&D kuya ezinqubweni zokukhiqiza futhi aqinisekise ukukhiqizwa kabusha nokuvumelana.

 

 

Ukubalwa kwamaseli kanye nokusebenza nge-Trypan Blue Staining Principle

Ukuqapha nokuhlaziya isiko lamaseli ngezixazululo zesimanjemanje.Ukuqapha okuthembekile nokusebenzayo kubalulekile ekuthuthukiseni umkhiqizo kanye nekhwalithi yomkhiqizo njengoba ngisho nezinguquko ezincane kumapharamitha we-bioprocess zingathonya ukusebenza kwesiko leseli lakho.Ukubalwa kwamaseli nokusebenza kwayo kuyimingcele ebaluleke kakhulu, i-Countstar Altair inikeza uhlaka oluhlakaniphe ngokwedlulele futhi oluhambisana ngokugcwele nesixazululo se-cGMP salokhu.

 

I-Countstar Altair iklanywe ngokusekelwe kumgomo wakudala we-Trypan Blue, ohlanganisa ibhentshi le-imaging le-optical elithuthukisiwe “lokulungisa ukugxilisa ingqondo,” ubuchwepheshe bokuqashelwa kwamaseli obuthuthuke kakhulu, nama-algorithms esofthiwe.Nika amandla ukuthola ulwazi lokugxiliswa kweseli, ukusebenza kahle, izinga lokuhlanganisa, ukujikeleza, nokusabalalisa kobubanzi ngokugijima okukodwa.

 

 

 

Ukusebenza kanye Nokunqunywa Kokudluliselwa Kwe-GFP Kumaseli

Ngesikhathi se-bioprocess, i-GFP ivame ukusetshenziselwa ukuhlanganisa amaprotheni ahlangene njengenkomba.Nquma i-GFP fluorescent ingabonisa i-protein expression.I-Countstar Rigel inikezela ngesivivinyo esisheshayo nesilula sokuhlola ukudluliselwa kwe-GFP kanye nokusebenza.Amaseli agcotshwe nge-Propidium iodide (PI) kanye ne-Hoechst 33342 ukuze achaze inani lamaseli afile kanye nengqikithi yamaseli.I-Countstar Rigel inikezela ngendlela esheshayo, yobuningi yokuhlola ukusebenza kahle kokuvezwa kwe-GFP nokusebenza ngesikhathi esifanayo.

Amaseli atholakala kusetshenziswa i-Hoechst 33342 (eluhlaza okwesibhakabhaka) futhi iphesenti lamaseli aveza i-GFP (aluhlaza) linganqunywa kalula.Amaseli angenakukwazi ukuphila angcoliswe i-propidium iodide (PI; ebomvu).

 

 

Ukuhambisana kokutholwa kwe-antibody ku-Countstar Rigel

Amasosha omzimba ahlobene ngokuvamile akalwa ngu-Elisa noma i-Biacore, lezi zindlela zizwela kakhulu, kodwa zibona i-antibody ngephrotheni ehlanzekile, kodwa hhayi iphrotheni yemvelo yemvelo.Sebenzisa indlela ye-cell immunofluorescence, umsebenzisi angakwazi ukubona ukuhlobana kwe-antibody neprotheyini ye-conformation yemvelo.Njengamanje, ukulinganisa kokuhambisana kwe-antibody kuhlaziywa nge-flow cytometry.I-Countstar Rigel futhi inganikeza indlela esheshayo nelula yokuhlola ukuhlobana kwe-antibody.
I-Countstar Rigel ingathwebula ngokuzenzakalelayo isithombe kanye nenani lokuqina kwe-fluorescence okungabonisa ukuhambisana kwe-antibody.

 

 

Kuhlanjululwe i-antibody ekugxiliseni okuhlukene, kwase kuhlanganiswe namaseli.Imiphumela itholwe ku-Countstar Rigel (kokubili isithombe nemiphumela yobuningi)

 

 

I-Countstar i-GMP-ilungele i-21 CFR Ingxenye 11

Amathuluzi e-Countstar athobelana ngokugcwele ne-21 CFR kanye neNgxenye 11, amasevisi e-IQ/OQ/PQ aqinisekisa ukulawula ukusebenza okungaguquki.Amathuluzi e-Countstar aselungele ukusetshenziswa ku-GMP kanye namalabhorethri athobelayo angama-21 CFR ingxenye 11.Ukulawulwa komsebenzisi nezindlela zokuhlola kuvumela imibhalo eyanele yokusetshenziswa enemibiko emisiwe ye-PDF.

Amadokhumenti e-IQ/OQ kanye nezingxenye zokuqinisekisa

 

 

 

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