[Raw Materials]
Peptide Engineering Center ntawm Shenzhen JYMed Technology Co., Ltd. Coj los ntawm pab pawg tshawb fawb ntawm 130 tus kws tshawb fawb, suav nrog 12 PhDs, lub chaw muaj kev txawj ntse hauv peptide synthesis thiab kev ua kom zoo dua. Siv cov khoom siv qib siab peptide synthesis (SPPS) thiab kua-theem peptide synthesis (LPPS) thev naus laus zis, ua ke nrog cov khoom siv hluav taws xob ntau lawm, peb ua kom cov khoom zoo thiab cov khoom ua haujlwm siab peptide. Peb pab pawg R & D muaj cov kev pabcuam dav dav los ntawm kev tsim qauv molecular mus rau txheej txheem kev txhim kho, muab cov kev daws teeb meem kom tau raws li cov neeg siv khoom xav tau.
Tag nrho cov dej num tau ua raws li cov qauv cGMP nruj, txhawb nqa los ntawm lub xeev-of-the-art analytical instrumentation xws li HPLC thiab huab hwm coj spectrometry (MS), kom ntseeg tau tias cov khoom zoo ua raws li cov kev cai thoob ntiaj teb pharmacopeial. Ntawm JYMed, peb tau cog lus los txhawb cov neeg siv khoom hauv kev txhim kho thiab kev lag luam ntawm kev kho tshiab los ntawm kev ua tau zoo hauv kev siv tshuab thiab kev pabcuam.
Kev tsim kho txheej txheem
JYMed cov txheej txheem kev txhim kho pab pawg tshwj xeeb hauv kev ua kom zoo dua qub thiab ntsuas peptide API kev tsim khoom, muab cov kev daws teeb meem zoo thiab txhim khu kev qha uas tau tsav los ntawm kev tsim kho thev naus laus zis. Nrog kev txawj ntse tob hauv SPPS, LPPS, thiab kev sib txuas txuas ntxiv mus, peb muab cov kev pabcuam kev txhim kho kawg-rau-kawg los ntawm kev tshuaj ntsuam milligram mus rau ntau pua-kilogram-scale tsim.
Los ntawm peb cov tswv cuab ntsuab chemistry platform rau peptides, peb tau kov yeej cov kev cov nyom hauv kev sib txuas ua ke, txhim kho qhov purity thiab tawm los. Qhov no ua rau peb ua tau raws li qhov yuav tsum tau ua ntawm high-potency peptides siv hauv oncology, kab mob metabolic, thiab lwm yam kev kho mob siab heev.
Peb cov txheej txheem tsim khoom nruj me ntsis ua raws li cGMP cov lus qhia thiab tau nruab nrog cov khoom siv hluav taws xob tag nrho thiab cov cuab yeej tshuaj ntsuam xyuas qib siab xws li UPLC thiab cov kev daws teeb meem siab MS. Ua ke nrog cov txheej txheem tsim kho kom zoo, peb ua kom cov txheej txheem robustness thiab batch-rau-batch sib xws. JYMed tau ua tiav ntau yam peptide API txoj haujlwm txhim kho thoob plaws hauv preclinical mus rau theem kev lag luam, xa cov ntaub ntawv ceev ceev, cov kev daws teeb meem los ua kom lub ntiaj teb cov tshuaj kho tshiab.
Kev tsim khoom
Peb qhov chaw tsim khoom spans 300 mu (kwv yees li 200,000 square metres) nrog tag nrho thaj tsam ntawm thaj tsam ntawm 54,000 square meters. Lub chaw muaj xws li peptide manufacturing Rhiav, QC thiab R&D cov tsev, Chav A thiab B warehouses, ib tug hnyav rov qab qhov chaw, cov chaw siv hluav taws xob, ib qho chaw khaws khib nyiab, thiab chaw kho dej khib nyiab.
Hubei Jianxiang Biopharmaceutical Co., Ltd. ua haujlwm 10 peptide API cov kab ntau lawm (nrog rau cov kab pilot-scale) ua raws li cov qauv cGMP ntawm Asmeskas, EU, thiab Tuam Tshoj. Cov no tau nruab nrog ntau lub zog-theem thiab kua-theem peptide synthesis reactors, tag nrho ntau dua 30,000 litres hauv reactor ntim.
Nrog rau kev tswj hwm kev tswj hwm tshuaj zoo thiab EHS kev ua raws cai, Hubei Jianxiang tau dhau los ntawm NMPA GMP kev tshuaj xyuas, ntau qhov kev tshuaj xyuas thib peb, thiab EHS kev tshuaj xyuas los ntawm cov neeg siv khoom thoob ntiaj teb. Nws lub peev xwm tsim peptide txhua xyoo tau mus txog ntau-tuj nplai. Qhov tseem ceeb, kev tsim khoom ntawm GLP-1 analogs nyob rau ntawm cov loj tshaj plaws nyob rau hauv Suav teb los ntawm ib lub ntim ntim, thiab qee cov tshuaj pleev ib ce peptides ntau tshaj 100 kg ib batch, tso lub tuam txhab raws li kev sib tw tshuaj synthesis peptide API chaw tsim tshuaj paus nyob rau hauv ob qho tib si domestic thiab thoob ntiaj teb kev lag luam.
High-Potency Peptide APIs
Jianxiang's high-potency peptide API cov kab ntau lawm sawv cev rau kev sib tw tseem ceeb, muab kev nyab xeeb thiab kev daws teeb meem zoo rau cov neeg siv khoom thoob ntiaj teb. Lub chaw muaj xws li ob OEB4-theem thiab ob OEB5-theem high-containment units tsim los ua kom tau raws li qhov xav tau kev tsim khoom ntawm cov khoom siv muaj zog xws li cov qog nqaij hlav thiab cytotoxic peptides, ua kom muaj kev nyab xeeb rau cov neeg ua haujlwm thiab ib puag ncig.
Cov kab ntau lawm siv kev lag luam ua lag luam SPPS thiab LPPS thev naus laus zis nrog kev tswj hwm kev tswj hwm tag nrho, ua kom muaj peev xwm tsim tau ntawm high-purity thiab high-potency peptides los ntawm gram mus rau kilogram nplai. Batch sib xws thiab cov khoom lag luam zoo tau ua raws li cov qauv tshuaj lag luam thoob ntiaj teb.
Ua los ntawm cGMP-raws li kev tswj hwm kev ua tau zoo, tag nrho cov txheej txheem tsim khoom - los ntawm kev xaiv cov khoom siv raw, kev sib txuas, kev ua kom huv mus rau qhov kev sim zaum kawg - yog tag nrho traceable. Advanced analytical instruments xws li HPLC thiab MS kom cov khoom purity ≥99% nrog tswj impurity profiles. Txhawm rau hais txog qhov tshwj xeeb kev nyab xeeb uas yuav tsum tau muaj ntawm APIs siab, OEB5-theem units tau txais kev kaw-kev cais tawm, kev ywj pheej tsis zoo-siab ib puag ncig, thiab cov kev soj ntsuam cov ntse ntse, nrog rau cov txheej txheem PPE nruj rau kev ruaj ntseg zoo.
Peb pab pawg R & D tseem muaj cov txheej txheem tsim kho thiab kev ua kom zoo tshaj plaws uas npog tag nrho cov txiaj ntsig ntawm kev tsim qauv molecular thiab scale-up rau cov kev tshawb fawb zoo, txhawb kev nce qib sai ntawm peptide-raws li kev kho mob.
[Formulation]
Peb pawg kws tshaj lij yog tsim los ntawm cov kws tshawb fawb txog kev paub tshwj xeeb hauv kev tsim thiab tshuaj xyuas kev tshawb fawb. Nrog kev txawj ntse thoob plaws tag nrho cov qauv tsim cov txiaj ntsig, peb muab cov kev pabcuam kawg-rau-kawg los ntawm kev tshawb fawb preclinical mus rau kev tsim khoom lag luam. Peb tau tsim tshwj xeeb technological zog nyob rau hauv pem hauv ntej teb xws li GLP-1 tshuaj, peptides thiab peptide formulations, sustained-tso peptide formulations, thiab radiopharmaceutical (RDC) kev loj hlob.
Leveraging peb thoob ntiaj teb kev faib R & D thiab cov chaw tsim khoom, peb tau tsim kom muaj kev tsim kho kev tsim kho. Nyob rau hauv daim teb peptide formulation, peb muab ntau yam kev daws teeb meem nrog rau ntau koob tshuaj / ib koob tshuaj cartridge txhaj tshuaj, lyophilized hmoov rau txhaj tshuaj, thiab inhalation daws. Hauv RDC txoj kev loj hlob, peb pab neeg tau ua kom zoo dua cov txheej txheem sib txuas rau radionuclides thiab tsom cov vectors, muab cov thev naus laus zis tshiab los txhawb kev kuaj mob oncology thiab kev kho mob. Raws li qhov kawg ntawm 2024, peb pab neeg tau txhawb ntau dua 100 qhov kev tsim kho tshuaj tshiab (nrog rau kev kho mob rau theem III), feem ntau tsom rau GLP-1 analogs, lwm yam tshuaj peptide, thiab RDCs. Peb kuj tau ua tiav 5 qhov kev tshuaj ntsuam xyuas cov tshuaj zoo sib xws uas suav nrog kev txhaj tshuaj thiab lwm yam tshuaj.
Raws li pab pawg neeg tsav tsheb thev naus laus zis, peb tseem cog lus rau kev tsim kho tshiab thiab kev txhais lus txuas ntxiv ntawm kev tshawb fawb rau hauv cov kev daws teeb meem tiag tiag. Peb cov kev siv zog tsis yog tsuas yog muab cov kev daws teeb meem zoo thiab muaj txiaj ntsig zoo rau lub khw muag tshuaj thoob ntiaj teb, txhawb nqa kev kho mob thiab kev siv tshuaj peptide thiab RDC cov tshuaj, tab sis kuj tsim kom muaj kev sib tw muaj zog hauv kev soj ntsuam cov tshuaj sib xws.
Kev tshawb nrhiav ua ntej
Raws li cov kauj ruam tseem ceeb hauv kev txhim kho tshuaj, kev tshawb fawb ua ntej tsim ua ib qho kev sib txuas tseem ceeb ntawm kev tshawb nrhiav tshuaj thiab kev tsim qauv. Nws cov kev ua tau zoo ncaj qha cuam tshuam rau daim ntawv loj hlob thiab kev ua tau zoo.
Rau kev txhim kho tshuaj tshiab, peb ua cov kev tshawb fawb txog cov yam ntxwv tseem ceeb ntawm APIs - suav nrog kev sim solubility, tshuaj ntsuam xyuas polymorph, yuam kev degradation tsom xam, thiab kev ntsuas kev ruaj ntseg ua ntej - txhawm rau txheeb xyuas cov yam ntxwv ntawm lub cev thiab txoj hauv kev muaj peev xwm degradation. Cov kev nkag siab no ua lub hauv paus rau kev tsim qauv, kev ua kom zoo dua qub, thiab kev txhim kho tus qauv zoo, thaum kawg txo qis R & D txaus ntshai thiab txhim kho kev siv tshuaj los ntawm qhov pib.
Hauv kev tsim tshuaj generic, kev tsom xam qhov tob ntawm cov ntaub ntawv teev npe tshuaj (RLD) yog qhov tseem ceeb ntawm kev tshawb fawb ua ntej. Los ntawm kev thim rov qab engineering, peb txiav txim siab cov qauv tsim, txheej txheem tsim khoom, thiab cov yam ntxwv tseem ceeb (CQAs) ntawm cov tshuaj pib. Qhov no ua rau lub hom phiaj kev taw qhia rau kev tsim cov qauv sib txuam thiab cov txheej txheem rov ua dua tshiab, thiab, raws li Txoj Cai Zoo los ntawm Tsim (QbD), kom ntseeg tau tias cov khoom lag luam ua tiav qhov sib npaug ntawm kev nyab xeeb, kev ua tau zoo, thiab kev tswj xyuas zoo-tso lub hauv paus rau kev soj ntsuam zoo sib xws.
Kev tsim kho cov qauv
Raws li tus choj tseem ceeb ntawm kev txhim kho tshuaj thiab kev lag luam, kev tsim kho cov qauv ua lub luag haujlwm tseem ceeb hauv kev txhais cov txiaj ntsig lab rau hauv kev siv tshuaj kho mob. Peb pab neeg tsom mus rau kev tsim cov thev naus laus zis tshiab thiab tsim kom muaj kev lag luam muaj peev xwm, tsim kom muaj kev txhim kho tag nrho uas suav nrog kev tsim qauv, kev ua kom zoo dua qub, kev tshawb fawb zoo, thiab kev tsim qauv tsim. Peb muab cov kev daws teeb meem customized raws li hom tshuaj sib txawv (me me molecules, peptides, radiopharmaceuticals) thiab ntau npaum li cas (injectables, inhalation products, sustained-release formulations).
Hauv kev tsim kho tshuaj tshiab, peb pib peb txoj haujlwm ntawm cov ntaub ntawv tsim ua ntej thiab txiav txim siab txog kev npaj thiab kev tswj hwm txoj hauv kev rau daim ntawv ntau npaum li cas thiab cov txheej txheem tsim. Rau kev ruaj ntseg cov nyom ntawm cov tshuaj peptide, peb tau tsim ntau koob tshuaj / ib koob tshuaj cartridge txhaj tshuaj thiab lyophilized hmoov txhaj tshuaj. Los ntawm optimizing buffer systems thiab lyophilization txheej txheem, peb ho txhim kho cov khoom stability. Rau RDCs, peb tau tsim cov txheej txheem conjugation meej ntawm cov hom phiaj vectors thiab radionuclides nrog rau cov kev tswj xyuas kom zoo los xyuas kom meej cov xov tooj cua zoo thiab nyab xeeb. Siv lub computer-aided formulation design (CADD) thiab QbD cov hauv paus ntsiab lus, peb ua kom zoo dua cov qauv tsim thiab cov txheej txheem tsis zoo los tswj cov ntsuas kev ua haujlwm tseem ceeb xws li kev sib cais, tso tawm cov ntaub ntawv, thiab kev coj cwj pwm.
Hauv kev txhim kho tshuaj generic, peb muab cov kev tsim kho rov qab ntawm RLDs nrog rau kev ua kom zoo dua qub kom ua tiav cov qauv tsim thiab txheej txheem sib npaug. Rau cov ntaub ntawv ntau npaum li cov tshuaj txhaj thiab nqus tau pa, peb ua kom raug CQA xws li particle loj faib, purity, thiab impurity profiles. Los ntawm cov txheej txheem scale-up thiab pilot-scale validation, peb xyuas kom meej tias generics phim cov tshuaj siv nyob rau hauv kev nyab xeeb, kev ua tau zoo, thiab kev tswj kev tsim khoom-ua kom muaj txiaj ntsig kev pom zoo.
Txog rau tam sim no, peb tau ua tiav kev txhawb nqa ntau dua 30 txoj haujlwm tsim kho tshiab rau cov tshuaj tshiab thiab cov khoom siv dav dav, suav nrog GLP-1 cov tshuaj, peptide sustained-tso formulations, thiab RDCs. Peb tau kov yeej cov kev tsis sib haum xeeb xws li peptide degradation, kev siv hluav taws xob tsis zoo, thiab cov kev sib tw loj hauv cov ntaub ntawv ntau npaum li cas. Los ntawm kev sim ntsuas qhov ntsuas mus rau GMP-raws li kev sim tsim, peb tau siv los ntawm ob lub cav ntawm "kev tsim kho thev naus laus zis + kev lag luam txhais lus," muab kev txhawb nqa rau kev tsim tshuaj tshiab los ntawm lub tswv yim mus rau hauv tsev kho mob, thiab ua kom muaj txiaj ntsig zoo, raug nqi ntau ntawm cov khoom lag luam uas tsav kev hloov pauv zoo los ntawm R & D cov txiaj ntsig rau cov nqi kho mob.
Formulation Manufacturing
Raws li cov kauj ruam kawg hauv kev txhais cov tshuaj R & D rau hauv kev siv tshuaj kho mob, kev tsim khoom tsim tawm yog qhov tseem ceeb txuas uas txuas nrog kev sim tshiab tshiab nrog cov khoom lag luam. Cia siab rau peb cov chaw tsim khoom thoob ntiaj teb thiab cov kab tsim khoom ntse, peb tau tsim kom muaj cov saw hlau ntau lawm uas suav nrog kev ntsuas kev ntsuas, kev siv tau, thiab kev lag luam-kev tsim khoom. Nrog lub peev xwm muaj zog thoob plaws ntau hom tshuaj, cov khoom lag luam, thiab cov lus qhia tshwj xeeb, peb ua tau raws li qhov xav tau ntawm cov tshuaj tshiab los ntawm kev kho mob mus rau kev lag luam, thaum txhawb nqa cov khoom lag luam zoo, loj loj ntawm cov tshuaj generic.
1. Kev Muaj Peev Xwm Txheej Txheem & Kev Tsim Khoom Siv Hluav Taws Xob
Muaj peev xwm ntau npaum li cas: Rau cov tshuaj nyuaj xws li peptides thiab RDCs, peb tau tsim GMP-raws li kev tsim khoom tshwj xeeb rau ntau cov koob tshuaj / ib koob tshuaj cartridge txhaj tshuaj daws teeb meem thiab lyophilized hmoov txhaj. Nruab nrog automated filling, lyophilization, thiab sterile filtration technologies, peb xyuas kom meej qhov kawg-rau-kawg automated tswj los ntawm raw khoom nkag mus rau cov khoom tiav ntim.
Rau peptide formulations, peb daws cov teeb meem kev ruaj ntseg los ntawm qhov kev ua kom zoo dua qub, kho cov lyophilization profiles, thiab cov saw hlau txias txias. Peb cov txheej txheem ua tiav cov txheej txheem scale-up, tsim los ntawm QbD lub moj khaum, ua kom muaj kev hloov pauv ntawm kev sim ntsuas ntsuas mus rau kev tsim cov qauv tsim (10L-100L), ua kom cov txheej txheem rov tsim dua tshiab thiab batch-rau-batch sib xws ntawm kev soj ntsuam thiab kev siv tau ntawm cov txheej txheem tseem ceeb (CPPs).
Kev txhawb nqa tshuaj tshiab: Peb cov txheej txheem tsim khoom suav nrog Kev Kho Mob Phase I-III cov qauv tsim khoom thiab kev tso npe cov ntawv xa tawm, ua kom cov sijhawm siv tshuaj tshiab.
Kev tsim tshuaj ntau lawm: Peb muab cov txheej txheem hloov pauv sai thiab cov kev daws teeb meem kom tau raws li qhov xav tau thoob ntiaj teb rau cov nqi tsim nyog, cov khoom lag luam zoo.
2. Kev Tswj Xyuas Zoo & Kev Ua Raws Cai
Peb tau tsim kom muaj kev tswj hwm lub neej zoo ntawm cov khoom siv raw khoom, kev soj ntsuam hauv txheej txheem, thiab cov khoom kawg tso tawm. Peb cov chaw tau nruab nrog cov cuab yeej tshuaj ntsuam xyuas qib siab xws li HPLC, LC-MS, thiab xov tooj cua-TLC scanners, ua kom muaj kev ntsuam xyuas tseeb ntawm CQAs suav nrog impurity profiles, cov ntsiab lus sib xws, tsis muaj menyuam, thiab kev siv hluav taws xob radiolabeling.
Peb cov chaw tsim khoom tau lees paub los ntawm Tuam Tshoj NMPA rau GMP kev ua raws cai thiab ua raws li ICH cov lus qhia, kom ntseeg tau tias tag nrho traceability thiab kev tswj hwm thoob ntiaj teb rau peb cov neeg siv khoom thoob ntiaj teb.
3. Muaj nuj nqis & kev ua tiav
Txog rau tam sim no, peb tau ua tiav kev nce qib thiab kev lag luam ntau dua 100 cov khoom tsim, suav nrog GLP-1 txhaj tshuaj, peptide sustained-tso formulations, thiab tsom RDC tshuaj. Peb lub peev xwm tsim tau txhua xyoo ncav cuag kaum tawm lab koob tshuaj / vials. Peb muab "ib-nres" cov kev pabcuam tsim khoom uas txhawb nqa cov tshuaj tshiab los ntawm cov qauv kuaj mob mus rau kev lag luam tawm, ua rau lub sijhawm luv luv rau kev ua lag luam. Los ntawm cov txheej txheem optimization thiab automation hloov khoom dua tshiab, peb pab cov neeg siv tshuaj generic ua tiav kev tswj hwm tus nqi thiab kev txhim kho kom zoo, pab txhawb kev nkag mus rau thoob ntiaj teb ntawm kev kho tus nqi siab.
Los ntawm kev txhais lus thev naus laus zis mus rau kev tsim khoom loj, peb txhawb nqa cov ntsiab lus ntawm "kev ua tau zoo ua ntej, kev ua haujlwm tau zoo," seamlessly integrating R & D nrog kev tsim khoom los ua ib tus neeg ntseeg siab hauv kev hloov kho tshuaj tshiab rau hauv kev kho mob thoob ntiaj teb.
