I-VEN ihlinzeka ngezinsizakalo zobuchwepheshe ekwakhiweni kobunjiniyela, ukucubungula nokukhiqiza, ukuphathwa kwephrojekthi, ukuqinisekiswa, kanye nensizakalo yokuthengisa ngemuva kokuthengisa. Ihlinzeka izinkampani ze-biopharmaceutical ezifana nemithi yokugoma, imishanguzo ye-monoclonal antibody, imithi ye-protein recombinant, nezinye izinkampani ze-biopharmaceutical ngomuntu ngamunye kusuka elabhorethri, ukuhlolwa komshayeli kuya esikalini sokukhiqiza. Uhla olugcwele lwama-mammalian cell culture bioreactors kanye nezixazululo zobunjiniyela ezisha. Ukuklanywa nokukhiqizwa kwama-bioreactors alandela ngokuqinile imithetho ye-GMP kanye nezimfuneko ze-ASME-BPE, kwamukele umklamo ochwepheshile, osebenziseka kalula, osetshenziswayo, kanye nezinhlanganisela zedizayini eziphelele nezivumelana nezimo ukuze kuhlangatshezwane nezidingo zesiko leqoqo lamaseli.

Yakhiwa iyunithi yethangi, iyunithi eshukumisayo, iyunithi yokulawula izinga lokushisa lejazi, iyunithi yokungenisa umoya yezindlela ezine, iyunithi yokukhipha umoya, iyunithi yokudla nokugcwalisa, iyunithi yokusampula nokuvuna, iyunithi yokulawula ezishintshayo kanye nesisetshenziswa esivamile. iyunithi. Uhlelo lokuzithiba luhambisana nendinganiso yamazwe ngamazwe ye-S88, enesakhiwo esicacile, ukuqoshwa kwedatha yomlando ephelele, ukugcinwa, ukuphatha, ukuboniswa kwegrafu ethrendayo kanye nemisebenzi yokuhlaziya idatha yokuqeqeshwa, ngokuhambisana ne-GAMP5; umsebenzi wokulandela umkhondo (irekhodi le-elekthronikhi/isiginesha ye-elekthronikhi), ngokuhambisana ne-CFR 21 PART11.

Umkhiqizo ulungele isiko lokumiswa ngokugcwele, isiko lokuthwala amashidi kanye nesiko le-microcarrier lemithi yebhayoloji enjengamasosha omzimba kanye nemithi yokugoma (njengomuthi wokugomela amarabi, i-FMD) neminye imithi yebhayoloji esikalini sokuhlola nokukhiqiza.