Sezvo marapirwo ari kuramba achiwedzera anobuda mwedzi wega wega, kufambisa tekinoroji inoshanda pakati pebiopharmaceuticals nevagadziri kwakakosha kupfuura nakare kose.Ken Foreman, Mutungamiriri Mukuru weChigadzirwa Strategy kuIDBS, anotsanangura nzira yakanaka yedhijitari inogona kukubatsira iwe kudzivirira zvakajairika kutamisa tekinoroji kukanganisa.
Biopharmaceutical Life Cycle Management (BPLM) ndiyo kiyi yekuunza mishonga mitsva yekurapa uye inoponesa hupenyu pasi rose.Inobata matanho ese ekugadzirwa kwezvinodhaka, kusanganisira kuzivikanwa kwevanoda zvinodhaka, miedzo yekiriniki yekuona kushanda kwayo, maitiro ekugadzira, uye zviitiko zvekutengesa kuendesa mishonga iyi kuvarwere.
Imwe neimwe yeaya yakatwasuka pombi mashandiro anowanzo kuwanikwa munzvimbo dzakasiyana dzesangano, nevanhu, zvishandiso, uye maturusi edhijitari akagadzirirwa izvo zvinodiwa.Kuchinjisa tekinoroji ndiyo nzira yekuvharisa mikaha pakati pezvikamu izvi zvakasiyana kuendesa budiriro, kugadzira uye ruzivo rwekusimbisa.
Nekudaro, kunyangwe iwo akanyanya kusimbiswa biotech makambani anotarisana nematambudziko mukubudirira kuita tekinoroji kutumira.Nepo dzimwe nzira (dzakadai semamonoclonal antibodies uye mamorekuru madiki) akakodzera nzira dzepuratifomu, dzimwe (sero sero uye gene therapy) ichiri nyowani kuindasitiri, uye kuoma nekusiyana kwemishonga mitsva iyi inoramba ichiwedzera kune yatove isina kusimba. process Wedzera kumanikidza.
Kuchinjisa tekinoroji idanho rakaomarara rinosanganisira vatambi vakawanda muchikamu chekugovera, mumwe nemumwe achiwedzera matambudziko avo kune equation.Vatsigiri veBiopharmaceutical vane simba rekutonga chirongwa chese, kuenzanisa chivakwa chekugovera cheni nekuronga kwavo kwakasimba kunoda kukurumidzira nguva yekutengesa.
Vanogashira tekinoroji vanogamuchira zvakare vane yavo yakasarudzika matambudziko.Vamwe vagadziri vataura nezve kubvuma kuomarara tekinoroji zvinodiwa pasina mirairo yakajeka uye yakapfupika.Kushaikwa kwegwara rakajeka kunogona kukanganisa kunaka kwechigadzirwa uye kazhinji kukuvadza kudyidzana mukufamba kwenguva.
Gadzira cheni yekugovera pakutanga kweiyo tekinoroji yekufambisa maitiro paunenge uchisarudza yakanyanya kukodzera nzvimbo yekugadzira.Izvi zvinosanganisira ongororo yekugadzirwa kwechirimwa chemugadziri, ongororo yavo pachavo uye kutonga kwemaitiro, uye kuwanikwa uye kugona kwemidziyo.
Pakusarudza yechitatu-bato CMO, makambani anofanirwawo kuongorora kugadzirira kweCMO kushandisa mapuratifomu ekugovana.Vagadziri vanopa data rakawanda mumafaira eExcel kana pabepa vanogona kukanganisa kugadzirwa uye kutarisa, zvichikonzera kunonoka kuburitswa.
Zvishandiso zvemazuva ano zviripo zvekutengesa zvinotsigira shanduko yedhijitari yekubika, zvitupa zvekuongorora, uye batch data.Nezvishandiso izvi, process information management systems (PIMS) inogona kushandura tekinoroji kutamiswa kubva kumitambo yakamira kuenda kune inosimba, inoenderera uye inodyidzana yekugovana ruzivo.
Kuenzaniswa nedzimwe nzira dzakaoma dzinosanganisira mapepa, maspredishiti uye masisitimu akasiyana, kushandiswa kwePIMS kunopa nzira inoenderera yekuongorora maitiro kubva kune manejimendi manejimendi kusvika kuzere kuteedzera kwakanakisa kuita nenguva shoma, mutengo uye njodzi.
Kuti ubudirire, tekinoroji yekuchinjisa mhinduro mukati mehutano hwekushambadzira uye kushambadzira kudyidzana kunofanirwa kunge kwakazara kupfuura mhinduro dzakatsanangurwa pamusoro.
Hurukuro ichangoburwa neGlobal COO yeLeading Industry Marketing Director yakaratidza kuti nhamba yekutanga chipingamupinyi chekuparadzana pakati pematanho eBPLM kushaikwa kweiyo inotengeswa tekinoroji yekufambisa mhinduro inovhara zvikamu zvese zvehurongwa, kwete kungopedza kugadzirwa.chiitiko.Ichi chinodiwa chinotonyanya kukosha muzvirongwa zvekuwedzera kwebiopharmaceutical yekugadzirwa kwakakura kwemishonga mitsva yekurapa.Kunyanya, vatengesi vezvinhu zvakasvibirira vanofanirwa kusarudzwa, zvinodikanwa zvenguva zvinotariswa, uye nzira dzekuongorora dzekuongorora dzakabvumiranwa, zvese izvo zvinoda kuvandudzwa kwemaitiro akajairwa ekushanda.
Vamwe vatengesi vakagadzirisa mamwe matambudziko vari voga, asi mamwe mabasa eBPLM haasati awana mhinduro kunze kwebhokisi.Nekuda kweizvozvo, makambani mazhinji anotenga "point mhinduro" iyo isina kugadzirwa kuti ibatanidzwe pamwe chete.Yakatsaurirwa pane-nzvimbo software mhinduro dzinogadzira zvimwe zvipingamupinyi zvehunyanzvi, sekutaurirana pamadziro emoto ane makore ekugadzirisa, kudiwa kwemadhipatimendi eIT kujairana nemaprotocol matsva, uye kusanganisa kusanganisa nemidziyo isina Indaneti.
Mhinduro ndeyekushandisa yakasanganiswa data mugwagwa unorerutsa manejimendi data, kufamba uye kuchinjana pakati pezvishandiso zvakasiyana.
Vamwe vanhu vanodavira kuti mipimo ndiyo kiyi pakugadzirisa zvinetso.ISA-88 ye batch manejimendi muenzaniso weyekugadzira chiyero chakagamuchirwa nemakambani mazhinji ebiopharmaceutical.Nekudaro, iko kuita kweiyo chiyero kunogona kusiyanisa zvakanyanya, zvichiita kuti kubatanidzwa kwedhijitari kuome kupfuura zvaida kutanga.
Muenzaniso ndiko kugona kugovana nyore ruzivo nezve mabikirwo.Nhasi, izvi zvichiri kuitwa kuburikidza neakareba Shoko gwaro rekugovera kutonga marongero.Mazhinji makambani anosanganisira ese zvikamu zveS88, asi iyo chaiyo fomati yefaira rekupedzisira zvinoenderana neanotsigira mushonga.Izvi zvinoita kuti CMO ienderane nemaitiro ese ekutonga kune maitiro ekugadzira ega ega mutengi mutsva wavanotora.
Sezvo vatengesi vanowedzera kuita maturusi anoenderana neS88, shanduko uye kuvandudzwa kweiyi nzira zvinogona kuuya kuburikidza nekubatanidzwa, kutora uye kudyidzana.
Dzimwe nyaya mbiri dzakakosha kushaikwa kwemazwi akajairika ehurongwa uye kusabuda pachena mukutsinhana data.
Mumakore gumi apfuura, makambani mazhinji emishonga akaita zvirongwa zvemukati zve“harmonization” kuti vaenzanise nevashandi vavo mashandisirwo emazwi akajairika kumatanho nemasystem.Nekudaro, kukura kwe organic kunogona kuita mutsauko sezvo mafekitori matsva akamiswa pasi rese, achigadzira ega maitiro emukati, kunyanya pakugadzira zvigadzirwa zvitsva.
Nekuda kweizvozvo, kune kushushikana kuri kukura pamusoro pekushaikwa kwekufanoona mukugovaniswa kwedata kuvandudza bhizinesi nekugadzira maitiro.Iri bhodhoro rinogona kuwedzera sezvo makambani makuru ebiopharmaceutical ari kuramba achifamba kubva mukukura kweorganic kuenda pakutenga.Makambani mazhinji makuru emishonga akagara nhaka dambudziko iri mushure mekuwana makambani madiki, saka kana vakamirira kwenguva yakareba kuti kuchinjana kwedata kugadziriswe, kunowedzera kukanganisa.
Kushaikwa kwemazwi akajairika ekududza maparamendi kunogona kutungamirira kumatambudziko kubva kunyonganiso iri nyore pakati pemainjiniya ekukurukura maitiro kusvika kune kusawirirana kwakakomba pakati pe data control data inopihwa nemasaiti maviri akasiyana anoshandisa maparamita akasiyana kuenzanisa mhando.Izvi zvinogona kutungamira kune zvisiri izvo kuburitsa batch sarudzo uye kunyangwe iyo FDA's "Fomu 483", iyo yakanyorwa kuti ive nechokwadi chekuvimbika kwedata.
Kugovera data redhijitari kunodawo kupihwa kutariswa kwakanyanya mumatanho ekutanga eiyo tekinoroji nzira yekufambisa, kunyanya kana kudyidzana kutsva kwakatangwa.Sezvambotaurwa, kubatanidzwa kwemudiwa mutsva mukutsinhana kwedhijitari kungada shanduko yetsika mukati meseti yekugovera, sezvo vanobatana vangada zvishandiso zvitsva uye kudzidziswa, pamwe nehurongwa hwakakodzera hwekondirakiti, kuve nechokwadi chekuenderera mberi kwekuteedzera kwemapato ese ari maviri.
Dambudziko guru rinotarisana neBig Pharma nderekuti vatengesi vanovapa mukana kune masisitimu avo sezvinodiwa.Nekudaro, ivo vanowanzo kanganwa kuti vatengesi ava vanochengetawo data revamwe vatengi mumadhatabhesi avo.Semuyenzaniso, iyo Laboratory Information Management System (LIMS) inochengetedza mibairo yekuongorora yezvese zvigadzirwa zvinogadzirwa nemaCMO.Naizvozvo, mugadziri haape mukana weLIMS kune chero mutengi wega kuitira kuchengetedza kuvanzika kwevamwe vatengi.
Pane nzira dzinoverengeka dzekugadzirisa dambudziko iri, asi imwe nguva inodiwa kugadzira uye kuyedza zvishandiso zvitsva uye maitiro anopihwa nevatengesi kana kugadzirwa mumba.Muzviitiko zvose izvi, zvakakosha zvikuru kusanganisa dhipatimendi reIT kubva pakutanga, sezvo kuchengetedzwa kwedata kwakakosha, uye firewall inogona kuda network yakaoma kuchinjanisa data.
Kazhinji, kana makambani ebiopharmaceutical akaongorora kukura kwavo kwedhijitari maererano nemikana yekufambisa tekinoroji yeBPLM, vanofanirwa kuona mabhodhoro akakosha anotungamira mukukwira kwemitengo uye / kana kunonoka mukugadzirira kugadzira.
Vanofanira kumepu maturusi avanotova nawo uye kuona kana maturusi iwayo akakwana kuzadzisa zvinangwa zvebhizinesi ravo.Kana zvisiri, ivo vanofanirwa kuongorora maturusi ayo indasitiri inofanirwa kupa uye kutsvaga vadyidzani vanogona kubatsira kuvhara gaka.
Sezvo magadzirirwo ekugadzira tekinoroji achienderera mberi nekushanduka, shanduko yedhijitari yeBPLM ichavhura nzira yemhando yepamusoro uye nekukurumidza kutarisirwa kwevarwere.
Ken Forman ane anopfuura makore makumi maviri nemasere eruzivo uye hunyanzvi muIT, mashandiro, uye chigadzirwa & manejimendi eprojekiti akatarisana nesoftware nenzvimbo yemishonga. Ken Forman ane anopfuura makore makumi maviri nemasere eruzivo uye hunyanzvi muIT, mashandiro, uye chigadzirwa & manejimendi eprojekiti akatarisana nesoftware nenzvimbo yemishonga.Ken Foreman ane makore anopfuura makumi maviri nemasere ehunyanzvi uye hunyanzvi muIT, mashandiro uye chigadzirwa uye manejimendi eprojekiti akatarisana nesoftware nemishonga.Ken Foreman ane makore anopfuura makumi maviri nemasere ehunyanzvi uye hunyanzvi muIT, mashandiro uye chigadzirwa uye manejimendi eprojekiti akatarisana nesoftware nemishonga.Asati ajoinha Skyland Analytics, Ken aive Director weNAM Program Management kuBiovia Dassault Systemes uye akabata zvinzvimbo zvakasiyana-siyana zvevatungamiriri kuAegis Analytical.Pakutanga, aive Chief Information Officer kuRally Software Development, Chief Commercial Officer kuFischer Imaging, uye Chief Information Officer kuAllos Therapeutics neGenomica.
Vanopfuura 150,000 vashanyi pamwedzi vanoishandisa kutevera bhizinesi rebiotech uye hunyanzvi.Ndinovimba unonakidzwa nekuverenga nyaya dzedu!