GMP Qib Peptide Manufacturing|cGMP Peptide Manufacturing|Clinical Peptide Supply|Kev tshawb fawb-Peptide
Xav tau GMP qib peptide rau kev sim tshuaj lossis kev lag luam? Kev tshawb fawb-Peptide muab GMP Qib Peptide Manufacturing kev pabcuam, uas ua raws li FDA / EMA cGMP tus qauv, thiab txhawb nqa IND cov ntaub ntawv rau cov khoom lag luam . 20 xyoo dhau los, thiab ntau dua 100 pawg peptide rau kev siv tshuaj kho mob tau xa tuaj. Txais tos tiv tauj peb.
Koj peptide mus rau hauv tsev kho mob? GMP kev tsim khoom yog qhov nyuaj tom ntej
Vim li cas peb yuav tsum xav txog GMP ntau lawm tam sim no?
Nyob rau theem ntawm txoj haujlwm no, koj tuaj yeem nug: qib kev tshawb fawb peptide peb tau siv ua ntej yog qhov zoo heev, vim li cas peb thiaj li yuav tsum ua GMP Qib Peptide Manufacturing?
Qhov txawv yog qhov yooj yim: kev tshawb fawb-qib peptides yog rau "discovery", thaum GMP- qib peptides yog rau "neeg". Thaum koj peptide npaj txhij los siv rau hauv kev sim tshuaj, cov neeg tswj xyuas yuav saib xyuas txhua yam - qhov twg cov ntaub ntawv raw tuaj, cov txheej txheem tswj tau li cas, muaj pes tsawg impurities tam sim no, thiab cov khoom ruaj khov npaum li cas. Cov no tsis yog cov lus nug uas tshawb fawb - qib peptides tuaj yeem teb tau.
Lub hauv paus ntawm GMP Qib Peptide Manufacturing yog los xyuas kom meej tias txhua pawg ntawm peptide tsim muaj kev nyab xeeb, muaj txiaj ntsig zoo thiab zoo ib yam nrog lub kaw lus uas tuaj yeem tiv taus kev tshuaj xyuas. Peb tau nrog ntau tus ntawm peb cov neeg siv khoom raws li txoj hauv kev los ntawm IND ua ntaub ntawv mus rau Phase III kev kuaj mob mus rau kev lag luam.
Peb qhov chaw tsim khoom GMP
Science-Peptide yog nruab nrog tshwj xeeb tsim platforms rau txhua theem ntawm kev txhim kho tshuaj peptide:
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Cov chaw |
Thaj tsam |
Muaj nuj nqi |
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Kev Tshawb Fawb thiab Kev Txhim Kho Center |
1200㎡ |
txheej txheem kev txhim kho, analytical method validation, preclinical qauv npaj |
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GMP pilot site |
4800㎡ |
4 cov kab tsim khoom ywj pheej los txhawb kev tsim cov theem I-III kuaj kuaj (1-50 kg / batch) |
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cGMP API cov nroj tsuag |
10 daim |
Kev lag luam nplai ntau lawm, khoom-theem synthesis kettle txog 5000L, kua-theem tshuaj tiv thaiv kettle txog 3000L |
Txhua qhov chaw tsim thiab ua haujlwm raws li FDA / EMA cGMP cov qauv, muaj ntawv pov thawj thoob ntiaj teb ISO, thiab raug kuaj xyuas cov neeg siv khoom tsis tu ncua.
Peb GMP Qib Peptide Manufacturing Capabilities
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Qhov project |
Muaj peev xwm |
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scale ntawm ntau lawm |
Grams mus rau puas kilograms (scalable to tons) |
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Synthesis platforms |
solid-phase synthesis (SPPS), kua-phase synthesis (LPPS), solid-kua hybridization |
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Amino acid ntev |
2-40 amino acids |
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kev hloov kho muaj peev xwm |
Kev hloov kho GMP (PEGylation, fatty acid hloov kho, disulfide bonding, thiab lwm yam) tuaj yeem ua. |
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purity ntau |
Customized, mus txog 99.5% lossis ntau dua |
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kev ua raws cai |
cGMP (FDA/EMA), ICH Q7, ISO9001 |
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Cov ntaub ntawv system |
DMF filings, txheej txheem validation cov ntaub ntawv, stability ntaub ntawv, impurity profileing |
Vim li cas thiaj xaiv GMP Qib Peptide Manufacturing los ntawm Kepin Bio?
Vim li cas thiaj xaiv Science-Peptide's GMP Qib Peptide Manufacturing?
1. Kev paub dhau los hauv GMP ntau lawm, tau xa ntau tshaj 100 batch
Peb tau ua tiav ntau tshaj 100 pawg ntawm GMP Qib Peptide Manufacturing tej yaam num, npog tag nrho cov theem los ntawm IND ua rau kev lag luam. Peb tau ua lag luam ntau dua 10 APIs, suav nrog Atosiban, Terlipressin, Octreotide, Cetrorelix, thiab lwm yam, txhua tus tau ua tiav cov txheej txheem kev lees paub thiab kev tshawb fawb ruaj khov.
2. Tag nrho cov txheej txheem zoo los ntawm kev tsim (QbD)
Nyob rau theem txheej txheem txhim kho, peb tau qhia txog QbD lub tswv yim los txheeb xyuas cov txheej txheem tseem ceeb (CPP) thiab cov yam ntxwv tseem ceeb (CQA) kom ntseeg tau tias qhov ntsuas muaj zog - nce. Txawm tias nyob rau theem pib kho mob, peb khaws qhov chaw rau kev lag luam tom ntej -txog kom txo qis qhov kev pheej hmoo ntawm lig- theem txheej txheem hloov.
3. Kev tswj xyuas nruj nruj nrog cov khoom siv traceability
- Tag nrho cov txheej txheem kev tswj hwm zoo: kev tshawb pom nruab nrab, crude peptide purity, purity tom qab purification, impurity profile tsom xam.
- Kev kuaj pom muaj peev xwm: HPLC, UPLC, MS, MS / MS, Amino Acid Analysis, Moisture, Residual Solvent, Endotoxin, Microbial Limit, Elemental Impurities, thiab lwm yam.
- Cov kev tshawb fawb txog kev ruaj ntseg: ntev- lub sij hawm, nrawm, cuam tshuam qhov kev ntsuam xyuas los txhawb kev tsim kho hnub tas sij hawm.
4. Ua tiav cov ntaub ntawv tswj hwm kev txhawb nqa, kev tshaj tawm thoob ntiaj teb tsis muaj kev txhawj xeeb
Peb muab tag nrho cov ntaub ntawv uas ua tau raws li US FDA / European EMA ua ntaub ntawv thov:
- Cov ntaub ntawv DMF (tuaj yeem raug xam raws li cov neeg siv khoom tso cai)
- Cov txheej txheem validation tsab ntawv ceeb toom (nrog cov txheej txheem piav qhia, validation program thiab tau txais)
- Impurity Profileing (npog cov txheej txheem impurities, degradation impurities)
- Cov ntaub ntawv ruaj ntseg (txhawb lub sijhawm rov kuaj dua thiab hnub tas sij hawm teeb tsa)
- Hloov tswj thiab tswj kev sib txawv (raws li ICH Q10)
5. Kev ruaj ntseg ntawm cov saw hlau, tsis muaj kev ntshai ntawm kev cuam tshuam
- Dual-Kev yuav khoom: tsawg kawg yog ob tus neeg muag khoom tsim nyog rau cov ntaub ntawv tseem ceeb (resins, amino acids, cov kuab tshuaj).
- Strategic stockpiling: Khaws cov khoom ruaj ntseg ntawm cov khoom siv feem ntau los tiv thaiv cov kev xav tau uas xav tau.
- Ntau-poob ntau lawm: R&D, pilot cog thiab kev lag luam yog muab faib rau hauv peb cov nroj tsuag ywj siab los faib cov kev pheej hmoo.
6. Cov qauv yooj yim ntawm kev koom tes, nrog rau cov kev pabcuam
Txawm hais tias koj yog ib lub tuam txhab tshuaj tshiab, lub tuam txhab biotech, lossis lub tuam txhab muaj txiaj ntsig, peb muab kev sib koom ua ke hloov pauv nyob ntawm theem ntawm koj qhov project:
- Kev koom tes thaum ntxov: txheej txheem kev txhim kho + kev soj ntsuam cov qauv tsim, pob nqi.
- Tom qab-hloov: Peb tuaj yeem pab hloov thev naus laus zis mus rau koj lub chaw tsim khoom, lossis ntev - OEM ntau lawm.
- Kev them nyiaj yug ua ntaub ntawv: koom tes nrog rau ntawm - kev tshuaj xyuas qhov chaw thiab muab cov ntaub ntawv xav tau.
Cov xwm txheej dab tsi xav tau GMP Qib Peptide Manufacturing?
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Theem |
Dem |
Peb yuav ua li cas |
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IND tshaj tawm |
GLP / GMP raws toxicology ntau thiab kev kuaj mob ntau yuav tsum tau kuaj |
Kev loj hlob sai, muab tag nrho cov ntaub ntawv ua ntaub ntawv |
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Clinical Phase I/II |
Xav tau ntau yam khoom siv GMP, tshawb xyuas ntau npaum li cas |
Ntau-batch ntau lawm, txheej txheem muaj zog, tswj tsis pub dhau qhov profile |
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Clinical Phase III |
Yuav tsum muaj txheej txheem validation ntau kom paub meej tias kev lag luam ntawm cov txheej txheem |
Cov txheej txheem validation (PPQ), kev tshawb fawb kev ruaj ntseg |
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kev lag luam npe |
Xav tau cov khoom siv tas mus li, tus nqi optimization |
Txheej txheem optimization, dual- qhov chaw lav khoom, ntev - kev koom tes |
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generic tshuaj txhim kho |
Rov qab engineering yuav tsum tau tsim cov txheej txheem ua raws |
Heterogeneous pawg spectrometry tawm tsam tus thawj, tshaj tawm kev txhawb nqa |
Kev xa khoom thiab kev txhawb nqa
Daim ntawv xa tuaj:aseptic hnab / nruas, tuaj yeem ntim tau raws li cov neeg siv khoom xav tau (xws li hauv ob sab phlu tshwj xeeb, tiv thaiv nitrogen).
Cov ntaub ntawv nrog:COA (nrog purity, impurities, residual solvents, thiab lwm yam), cov txheej txheem validation report (negotiable), stability summary (optional).
Kev tswj hwm kev txhawb nqa:muab tag nrho cov ntaub ntawv xav tau rau kev ua ntaub ntawv, thiab koom tes nrog rau ntawm - kev tshuaj xyuas qhov chaw.
Kev hloov technology:Peb tuaj yeem pab hloov cov txheej txheem mus rau tus neeg siv khoom lub Hoobkas, lossis muab kev pabcuam OEM ntev -.
Tiag - piv txwv lub neej: los ntawm IND mus rau kev lag luam, txhua txoj hauv kev mus nrog
Case 1: Kev kho mob lig ntawm cov tuam txhab tshuaj tshiab
A domestic innovative pharmaceutical company is developing a peptide drug, ready to enter the phase III clinic, and needs 20 kilograms of GMP-grade materials. By utilizing our existing solid phase synthesis platform, we completed the process scale-up and 3 batches of GMP production in 4 months, with purity >98% thiab monohybrid<0.5% in all batches. The customer has successfully submitted NDA and has been approved for marketing, and we continue to supply API for commercialization.
Case 2: DMF ua ntaub ntawv txhawb nqa rau cov tuam txhab tshuaj txawv teb chaws
Lub tuam txhab tshuaj European tau npaj ua nws cov peptide API hauv Suav teb thiab xav tau kev txhawb nqa DMF los ntawm cov chaw tsim khoom cGMP hauv zos. Peb tau npaj DMF cov ntaub ntawv raws li ICH M4 hom ntawv thiab tso cai rau tus neeg siv los hais nws hauv daim ntawv. Cov neeg siv khoom tau txais kev pom zoo thiab peb tau dhau los ua ib feem tseem ceeb ntawm nws cov khoom siv hauv Asia.
Case 3: "Cov neeg tua hluav taws" thaum muaj xwm txheej tsis txaus
Lub tuam txhab tshuaj multinational kev lag luam peptide API, tus neeg muag khoom thawj zaug tau tso tseg vim muaj teeb meem ib puag ncig, ntsib lub ntiaj teb cov khoom tsis txaus. Peb tau txais kev txiav txim ceev kom xa 100 kg ntawm API nyob rau hauv 6 lub hlis, thiab peb tau npaj ob kab ntawm cov khoom siv -theem thiab kua-theem ntau lawm nyob rau hauv parallel, thiab thaum kawg xa cov khoom 2 lub lis piam ua ntej lub sij hawm, pab tus neeg muas zaub kom tsis txhob muaj kev tsis txaus nyob rau hauv lub khw.
Tam sim no, dab tsi txog koj qhov kev xav tau GMP?
Txawm hais tias theem twg ntawm koj qhov project - IND filing, kev sim tshuaj, lossis kev lag luam tawm - peb tuaj yeem muab koj cov kev pabcuam ua raws, txhim khu kev qha, thiab muaj txiaj ntsig GMP Qib Peptide Manufacturing services.
Thov qhia rau peb:
Peptide Sequence lossis Structure (Signable NDA Tsis pub twg paub)
theem tam sim no thiab xav tau ntau qhov loj
Cov kev xav tau zoo (purity, impurity txwv, thiab lwm yam)
Cov kev xav tau tshwj xeeb (piv txwv li, tu tu, ntim, ntaub ntawv)
Muab kev ntsuam xyuas ua tau zoo rau koj thiab hais lus hauv 24 teev.
