Binciken halittu, wanda aka fi sani da kwayoyin halittu ko magungunan halittu, sune gwaje-gwaje, kariya, da hanyoyin kwantar da hankalin da aka bunkasa kuma an gina ta ta hanyar tafiyar da kwayoyin halitta ta hanyar amfani da samfurin mutum, dabba ko microorganism. Wannan ya bambanta da kwayoyi masu magunguna, waɗanda aka haɓaka daga matakan sinadaran.
Akwai wasu abubuwa da suka samo asali daga mutane, dabbobi ko kwayoyin halitta da ake amfani da su a cikin kayayyakin halittu, kamar sugars, sunadarai, kwayoyin nucleic, sassan, jini ko kyallen takarda.
Yin amfani da fasahar kimiyya, an haɗa su ko sarrafa su don ƙirƙirar abubuwa waɗanda zasu taimaka mana gano asali , kulawa, sarrafawa, ko magance cututtuka da yanayin.
Daga cikin tsoffin jami'o'in halittu shine insulin , wadda aka samo daga dabbobin da farko. Abubuwan insulin ne na yau suna iya haifar da DNA mai sauƙi, wani tsari daban-daban, amma har yanzu yanayin halitta ne.
Magungunan kwayoyin halitta ne da suka samo asali. Ana ci gaba da su ta hanyar amfani da kwayar cutar ko kwayoyin da ke haifar da cutar da ake hana. Wannan zai iya zama kisa ko mummunan ɓangaren ƙwayar cuta, ko kuma zai iya zama furotin da aka tsarkake, sukari ko wani bangaren ɓangaren ƙwayar cuta.
Ta hanyar gabatar da wani zuwa wannan shiri da aka yi daga kwayar cutar ko kwayoyin tambaya kafin su kamu da rashin lafiya, jiki yana haɓaka ta hanyar gina ƙwayoyin cuta akan cutar. Daga baya, idan an bayyana, mai haƙuri ba zai ci gaba da cutar ba.
Shirin ne duk nazarin halittu.
Sauran gwaje-gwaje da tsararrake da aka saba da su sune halittu, ma. Samun jini da aka yi amfani da shi don transfusion , gwaje-gwaje da yawa na rashin lafiyar jiki, harkar cututtuka irin na waɗanda suke amfani da su don magance cututtuka na menopause, da kuma hanyoyin kwantar da hankulan kwayoyin da ake amfani dashi don bunkasawa ko bunƙasa sauran magunguna.
Jerin Biologics
Ya haɗa daga wasu albarkatun, a nan shi ne lissafi mai kyau na ilimin halitta:
- alurar riga kafi
- insulins
- interleukins
- ci gaban hawan dan adam
- maganin hormone, kamar amfani da estrogen ko testosterone
- gwaje-gwaje don nunawa masu bada taimako na jini ga HIV ko wasu magunguna masu cutar
- jini da samfurori na jini don transfusion
- jini da samfurori da aka yi amfani da su a masana'antu tare da wasu kayan
- haɓakar halittu da ake amfani dasu don bunkasa gwaje-gwaje da rashin lafiyar jiki
- sassan jikin mutum da kyallen takalma da aka yi amfani dashi don dasawa (misali, tendons, ligaments, da kashi)
- samfurin (DNA) hanyoyin kwantar da hankali (duba ƙasa *)
- tantance kwayoyin halitta (duba ƙasa *)
An sayar da waɗannan daga ƙarƙashin sunan mai yiwuwa wanda zai iya ganewa, kamar Avastin, Herceptin, Enbrel, Epotin, Remicade, Humira ko Avonex.
Binciken Halittu Ba Yayi Ƙayyade Tsakanin Ƙididdigar Generic
Ba kamar sauran kwayoyi masu magunguna ba, yawancin kwayoyin halittu ba su da abin da aka tsara a matsayin ainihin daidai . FDA ta bayyana nau'in kwayoyin halitta kamar yadda yake da nau'in nau'in mai aiki kamar mai amfani da magunguna. Ba wai kawai ba, amma kuma su ma sun kasance sunadarai - suna da nau'i nau'i guda, ƙarfi, ingancin, da kuma aikin. Maimakon haka, ilimin halittu yana da biosimilars, wanda doka ta bayyana a shekarar 2009.
Biosimilars
Biosimilars ne kwayoyi sun yarda da FDA wadanda ba su da bambanci na asibiti daga asali mai ma'anar kwayoyin halitta.
Ya kamata su kasance lafiya da kuma tasiri sosai kuma aiki a cikin hanyar da aka samo asali. Ana amfani da miyagun ƙwayoyi don canzawa idan ya dace da daidaituwa ta biosimilarity kuma ya kamata a canza shi da samfurin asali ba tare da ƙara yawan haɗari ba.
An ƙuntata takardar maganin kwayoyin kwayoyin halitta a Amurka har sai an sasanta Dokar Kulawa ta Sha'ida ta 2010. Tare da fasalin Dokar Kasuwanci na Kasuwanci na Halittu (BCPI) na 2009 da Dokar Tsaro da Dokar Kulawa ta 2010, nazarin halittu samfurori suna da hanyar yin lasisi ta hanyar FDA.
Ƙarin dabaru da sauransu zasu kasance a Amurka tare da wannan canji a cikin doka.
Kafin shekarar 2009, kungiyoyi da dama sun yi marhabin don karfafa FDA don fara barin masana'antar biosimilars ko biyan bayanan tsofaffiyar kwayoyin halittu a matsayin hanyar da za ta adana kudi na tsarin kiwon lafiya. Alal misali, insulin da kuma kayan insulin-sunaye na iya haɓaka daga $ 150 zuwa $ 1000 a kowace wata. Ƙididdiga mai bi-daidai zai iya biya kawai $ 25 a kowace wata. Lokacin da yawan mutanen da ke buƙatar irin wannan jiyya suka yawaita, za ka iya ganin yadda yardar waɗannan zane-zane na iya kiyaye tsarin biliyoyin.
Manyan masana'antun masana'antu sun yi haɗari game da ci gaba da kuma samar da biosimilar saboda ba su so su yi gasa ba tare da tsada ba, amma maganin lafiya (biyan kudi). Sun gabatar da matakan tsaro a cikin ci gaba da kuma rashin tabbacin cewa wadannan kwayoyi zasu zama tasiri kamar yadda asali.
Source
Bayani ga masu amfani (Biosimilars) - Cibiyar Abinci da Drugdin Amurka 8/27/2015.