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Design & Development & Testing of Biomaterials

Timateteza luntha lanu

Kupanga & Kupanga & Kuyesa kwa Biomaterials

KODI BIOMATERIALS NDI CHIYANI?

Ma biomatadium ndi zida zilizonse, zachilengedwe kapena zopangidwa ndi anthu, zomwe zimakhala zathunthu kapena gawo lanyumba kapena chida chamoyo chomwe chimagwira ntchito, kuwonjezera, kapena kusintha zina mwachilengedwe. Ma biomatadium ndi zinthu zomwe sizingagwiritsidwe ntchito pazida zamankhwala, chifukwa chake amapangidwa kuti azilumikizana ndi chilengedwe. Zidazi zimasinthidwa kuti zigwiritsidwe ntchito zachipatala. Ma biomaterials amatha kukhala ndi ntchito yabwino, monga kugwiritsidwa ntchito ngati valve yamtima. Ma biomatadium amagwiritsidwanso ntchito popanga mano, opaleshoni, komanso popereka mankhwala (zomanga ndi mankhwala opangidwa ndi mankhwala olowetsedwa zitha kuyikidwa m'thupi, zomwe zimalola kutulutsa kwanthawi yayitali kwa mankhwala kwa nthawi yayitali). Ma biomatadium samangokhala ndi zinthu zopangidwa ndi anthu zopangidwa ndi zitsulo kapena zitsulo. Biomaterial ingakhalenso autograft, allograft kapena xenograft yomwe imagwiritsidwa ntchito ngati chosinthira.

Ntchito zina za biomatadium ndi:

  • Mafupa a mafupa, Olowa m'malo, Mafupa simenti

  • Artificial ligaments & tendons

  • Ma implants ena a mano

  • Ma valve a mtima

  • Ma prostheses otengera magazi

  • Zida zokonzera khungu

  • Kuyika m'mawere

  • Ma lens

Ma biomatadium ayenera kukhala ogwirizana ndi thupi, ndipo nthawi zambiri pamakhala zovuta za biocompatibility. Nkhani zosemphana zotere ziyenera kuthetsedwa mankhwala asanayikidwe pamsika. Pali malamulo okhwima a biomatadium. Makampani opanga omwe amagwira ntchito ndi biomatadium amafunikiranso kuti awonetsetse kuti zinthu zonse zomwe zili ndi vuto lipezeka, zina zomwe zili mugulu lomwelo zitha kufufuzidwa mwachangu.

 

Biocompatibility ya biomatadium m'malo osiyanasiyana pansi pamikhalidwe yosiyanasiyana yamankhwala ndi thupi ndiyofunikira. Biocompatibility ingatanthauze zinthu zinazake popanda kufotokoza kumene kapena momwe zinthuzo ziyenera kugwiritsidwa ntchito. Mwachitsanzo, chinthu chikhoza kuchititsa kuti chitetezo cha mthupi chitetezeke pang'ono kapena sichingatheke m'thupi linalake, ndipo mwina sichingagwirizane ndi mtundu wina wa selo kapena minofu. Zida zamankhwala ndi ma prostheses nthawi zambiri amapangidwa ndi zinthu zingapo, chifukwa chake sizingakhale zokwanira nthawi zonse kunena za biocompatibility ya chinthu china.

 

Komanso, chinthu sichiyenera kukhala chapoizoni pokhapokha ngati chidapangidwa kuti chikhale chomwecho. Chitsanzo ndi njira zanzeru zoperekera mankhwala zomwe zimaloza ma cell a khansa ndikuwawononga. Kumvetsetsa bwino za thupi ndi thupi la malo ochitirapo kanthu ndikofunikira kuti biomaterial ikhale yogwira mtima. Chifukwa chake ndikofunikira, pakukonza, kuwonetsetsa kuti chidacho chikugwirizana komanso kukhala ndi phindu ndi gawo linalake la machitidwe.

 

Ma biopolymers amapangidwa kuchokera ku zamoyo. Ma cellulose ndi wowuma, mapuloteni, peptides, ndi DNA ndi RNA ndi zitsanzo za biopolymers, momwe ma unit monomeric, motero, ndi shuga, amino acid, ndi nucleotides. Cellulose ndi biopolymer yodziwika bwino komanso yodziwika bwino kwambiri padziko lapansi. Ma biopolymers ena amatha kuwonongeka. Ndiye kuti, amaphwanyidwa kukhala CO2 ndi madzi ndi tizilombo toyambitsa matenda. Zina mwa biopolymers zomwe zimatha kuwonongeka ndi compostable, zitha kuyikidwa munjira yopangira kompositi m'mafakitale ndipo zitsika ndi 90% mkati mwa miyezi 6. Ma biopolymers omwe amachita izi amatha kulembedwa ndi chizindikiro "compostable". Zopaka zolembedwa ndi chizindikirochi zitha kuyikidwa m'njira zopangira manyowa kuti ziwonongeke mkati mwa miyezi 6 kapena kuchepera. Chitsanzo cha compostable polima ndi PLA filimu pansi makulidwe ena. Makanema a PLA omwe ndi okhuthala kuposa amenewo sakuyenera kukhala compostable, ngakhale amatha kuwonongeka. Kompositi yakunyumba imatha kupangitsa ogula kutaya zotengera zawo pa mulu wawo wa kompositi.

 

NTCHITO ZATHU

Timapereka kapangidwe ka biomatadium, chitukuko, kusanthula ndi kuyesa ntchito zothandizira chitukuko ndi kuvomereza msika kwa zida zamankhwala ndi kuphatikiza kwa zida zamankhwala, upangiri, umboni waukatswiri ndi ntchito zamilandu.

 

Kupanga & Kukula kwa Biomaterials

Akatswiri athu opanga ma biomatadium ndi chitukuko ndi asayansi ali ndi ukadaulo pakupanga ndi kupanga biomaterials kwa opanga ma IVD akuluakulu okhala ndi zotsatira zotsimikizika mu zida zowunikira. Minofu yachilengedwe imapangidwa mwadongosolo pamasikelo angapo, imagwira ntchito zingapo zamapangidwe komanso zathupi. Ma biomatadium amagwiritsidwa ntchito m'malo mwa minyewa yachilengedwe ndipo iyenera kupangidwa mwanjira yomweyo. Akatswiri athu amaphunziro ali ndi chidziwitso ndi luso muzinthu zambiri zasayansi zazinthu zovutazi ndi ntchito monga biology, physiology, mechanics, kayeseleledwe ka manambala, chemistry yakuthupi ... etc. Ubale wawo wapamtima komanso zomwe adakumana nazo pakufufuza zamankhwala komanso mwayi wosavuta wowonetsa mawonekedwe ambiri ndi njira zowonera ndi zinthu zathu zamtengo wapatali.

 

Malo amodzi opangira mapangidwe, "Biointerfaces" ndiofunikira pakuwongolera kuyankha kwa cell ku biomaterials. Biochemical ndi physico-chemical katundu wa biointerfaces amayang'anira ma cell adhesion ku biomaterials ndi kutengeka kwa nanoparticles. Maburashi a polima, maunyolo a polima omwe amamangiriridwa kumapeto kwa gawo limodzi lokha ndi zokutira zowongolera ma biointerfaces. Zopaka izi zimalola kuti zigwirizane ndi mawonekedwe a physico-chemical of biointerfaces kudzera pakuwongolera makulidwe awo, kachulukidwe ka unyolo ndi chemistry ya mayunitsi awo obwereza ndipo angagwiritsidwe ntchito pazitsulo, zoumba ndi ma polima. Mwa kuyankhula kwina, amalola kusintha kwa bioactive katundu wamitundu yosiyanasiyana yazinthu, mosasamala kanthu za kuchuluka kwake komanso momwe zimapangidwira. Akatswiri athu a biomaterial adaphunzira kaphatikizidwe ka mapuloteni komanso kulumikizana ndi maburashi a polima, adafufuza momwe ma biomolecules amagwirira ntchito limodzi ndi maburashi a polima. Maphunziro awo ozama adathandizira popanga zokutira zopangira ma implants, ma in vitro cell culture system komanso kupanga ma vector operekera majini.

 

Geometry yoyendetsedwa ndi gawo lachilengedwe la minofu ndi ziwalo mu vivo. Maonekedwe a geometric a ma cell ndi minyewa pamasikelo angapo autali ndikofunikira paudindo ndi ntchito yawo, komanso chizindikiro cha matenda monga khansa. Mu vitro, pomwe ma cell ndi chikhalidwe pazoyeserera zamapulasitiki, kuwongolera uku kwa geometry kumatayika. Kumanganso ndi kuwongolera zina mwazinthu za geometrical za biological system mu vitro ndikofunikira pakupanga ma scaffolds opangira minofu ndi kapangidwe ka mayeso otengera ma cell. Zidzalola kulamulira bwino kwa phenotype ya selo, mapangidwe apamwamba ndi ntchito, zomwe ndizofunikira pakukonza minofu. Izi zidzalola kuwerengera kolondola kwa ma cell ndi organoid mu vitro ndikuwonetsetsa mphamvu ya mankhwala ndi chithandizo. Akatswiri athu opanga ma biomatadium apanga kugwiritsa ntchito zida zojambulira pamasikelo osiyanasiyana. Njira zopangira izi ziyenera kugwirizana kwathunthu ndi chemistry ya biomaterials yomwe nsanjazi zimakhazikitsidwa, komanso momwe ma cell amakhalira.

 

Pali zina zambiri zamapangidwe ndi chitukuko zomwe mainjiniya athu a biomatadium agwirapo ntchito yawo yonse. Ngati mukufuna zambiri zokhudzana ndi chinthu china chonde titumizireni.

 

Ntchito Zoyeserera za Biomaterials

Kupanga, kupanga ndi kupanga zinthu zotetezeka komanso zogwira mtima za biomaterial, ndikukwaniritsa zofunikira pakuvomerezedwa ndi kutsatsa, kuyezetsa kwa labotale kolimba kumafunika kuti timvetsetse zinthu zokhudzana ndi chitetezo chazinthu, monga chizolowezi chazinthu zotulutsa zinthu zomwe zimatha kutulutsa, kapena magwiridwe antchito. njira, monga mechanical properties. Tili ndi mwayi wochita zambiri zowunikira kuti timvetsetse zomwe zili, chiyero, ndi chitetezo chamoyo cha chiwerengero chochulukira cha biomaterials zomwe zimagwiritsidwa ntchito mu mankhwala pogwiritsa ntchito thupi, mankhwala. , makina, ndi njira zoyezera ma microbiological. Monga gawo la ntchito yathu timathandizira opanga kuwunika chitetezo cha zida zomalizidwa pothandizira kufunsira kwa toxicological. Timapereka ntchito zowunikira kuti tithandizire chitukuko cha zinthu ndi kuwongolera kwabwino kwa zopangira ndi zinthu zomalizidwa. Tili ndi chidziwitso ndi mitundu yambiri yazinthu zachilengedwe monga zamadzimadzi, ma gels, ma polima, zitsulo, zoumba, hydroxyapatite, zophatikiza, komanso zinthu zopangidwa ndi biologically monga collagen, chitosan, matrices a peptide, ndi alginates. Mayeso ena akulu omwe titha kuchita ndi awa:

  • Makhalidwe a Chemical ndi kusanthula kwazinthu zama biomaterials kuti amvetsetse bwino za chinthucho kuti chiperekedwe ndikuwongolera komanso kuzindikira kapena kuchuluka kwa zoipitsa kapena zowononga. Tili ndi mwayi wopeza ma lab omwe ali ndi njira zingapo zodziwira kapangidwe kake, monga kusanthula kwa infrared spectroscopy (FTIR, ATR-FTIR), nuclear magnetic resonance (NMR), size exclusion chromatography (SEC) ndi plasma yolumikizana molumikizana. spectroscopy (ICP) kuti azindikire ndikuwerengera zomwe zidapangidwa komanso kufufuza zinthu. Zambiri zokhudzana ndi biomaterial pamwamba zimapezedwa ndi SEM / EDX, komanso pazinthu zambiri ndi ICP. Njirazi zitha kuwonetsanso kupezeka kwa zitsulo zomwe zitha kukhala zapoizoni monga lead, mercury ndi arsenic mkati ndi pa biomaterials.

  • Makhalidwe odetsedwa pogwiritsa ntchito kudzipatula kwa labotale komanso njira zingapo za chromatography kapena mass spectrometry monga MALDI-MS, LC-MSMS, HPLC, SDS-PAGE, IR, NMR ndi fluorescence ... etc.

  • Kusanthula kwa ma polima a biomaterial kuti azindikire zinthu zambiri za polima komanso kudziwa mitundu yowonjezera monga mapulasitiki, ma colorants, anti-oxidants ndi zodzaza, zonyansa monga ma monomers osakhudzidwa ndi oligomers.

  • Kutsimikiza kwa mitundu yosangalatsa yachilengedwe monga DNA, Glycoaminoglycans, kuchuluka kwa mapuloteni… etc.

  • Kusanthula kwa zochitika zophatikizidwa mu biomatadium. Timachita kafukufuku wowunikira kuti tifotokoze kutulutsidwa kolamuliridwa kwa mamolekyu omwe akugwira ntchito monga maantibayotiki, ma antimicrobials, ma polima opangidwa ndi mitundu ina yochokera ku biomaterials.

  • Timachita maphunziro ozindikira komanso kuchuluka kwa zinthu zomwe zimatha kuchotsedwa komanso kutulutsa zomwe zimachokera ku biomatadium.

  • Ntchito za GCP ndi GLP bioanalytical zothandizira magawo onse a chitukuko cha mankhwala komanso kusapezeka kwa GLP mwachangu gawo la bioanalysis.

  • Kusanthula kwazinthu ndikuyesa kuyesa zitsulo kuti zithandizire chitukuko chamankhwala ndi kupanga GMP

  • Maphunziro okhazikika a GMP ndi kusungidwa kwa ICH

  • Kuyesa kwathupi ndi morphological ndi mawonekedwe a biomaterials monga kukula kwa pore, pore geometry ndi kugawa kukula kwa pore, kulumikizidwa, ndi porosity. Njira monga ma microscopy, scanning electron microscopy (SEM), kutsimikiza kwa madera a BET amagwiritsidwa ntchito kuzindikiritsa zinthu zoterezi. Njira za X-Ray diffraction (XRD) zimagwiritsidwa ntchito pophunzira kuchuluka kwa crystallinity ndi mitundu ya magawo muzinthu. 

  • Kuyesa kwamakina ndi kutentha komanso mawonekedwe a biomaterials kuphatikiza kuyesa kwamphamvu, kupsinjika-kupsinjika ndi kuyesa kutopa kwakanthawi pakapita nthawi, mawonekedwe a viscoelastic (dynamic mechanical) ndi maphunziro owunikira kuwonongeka kwa katundu pakuwonongeka.

  • Medical chipangizo kulephera kusanthula, kudziwa chimene chimayambitsa

 

Consulting Services

Titha kukuthandizani kuti mukwaniritse zofunikira pazaumoyo, zachilengedwe ndi zowongolera, kumanga chitetezo ndi mtundu pamapangidwe ndi zinthu, ndikuwongolera njira zopangira. Akatswiri athu opanga ma biomaterials ali ndi ukadaulo pakupanga, kuyesa, miyezo, kasamalidwe ka supply chain, ukadaulo, kutsata malamulo, toxicology, kasamalidwe ka projekiti, kukonza magwiridwe antchito, chitetezo ndi kutsimikizika kwamtundu. Akatswiri athu opanga upangiri amatha kuyimitsa zovuta zisanakhale zovuta, kuthandiza kuyang'anira ndikuwunika zoopsa ndi zoopsa, kupereka mayankho anzeru pazovuta zovuta, kupereka malingaliro amitundu ina, kukonza njira ndikupanga njira zabwino kwambiri zogwirira ntchito bwino.

 

 

Umboni Waukatswiri ndi Ntchito Zamilandu

AGS-Engineering biomaterials mainjiniya ndi asayansi adziwa zambiri popereka mayeso a patent ndi zochita zamalamulo zamalamulo. Adalemba malipoti a akatswiri a Rule 26, omwe adathandizira pakumanga zodandaula, adachitira umboni pakuyika ndi kuyeserera milandu yokhudzana ndi ma polima, zida, ndi zida zamankhwala zokhudzana ndi milandu yonse ya patent ndi mlandu wazinthu.

 

Kuti muthandizidwe pakupanga, kupanga ndi kuyesa kwa biomatadium, kufunsira, mboni zaukatswiri ndi ntchito zamilandu lemberani ife lero ndipo ofufuza athu a biomatadium angasangalale kukuthandizani.

 

Ngati mumakonda kwambiri luso lathu lopanga zinthu m'malo mwa luso la uinjiniya, tikukulimbikitsani kuti mupite patsamba lathu lopangira makondahttp://www.agstech.net

Zogulitsa zathu zachipatala zovomerezedwa ndi FDA ndi CE zitha kupezeka pa mankhwala athu azachipatala, zogwiritsidwa ntchito ndi zidahttp://www.agsmedical.com

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