JYMed tuaj yeem muab peptides'API thiab peptide tiav kev txhim kho ntau npaum rau koj qhov project, raws li hauv qab no:

[Peocess Development]

CQA

QBD

Kev txhim kho thiab kev txiav txim siab ntawm cov txheej txheem

Optimization ntawm txheej txheem

3 batch ntau lawm los ntsuam xyuas qhov ua tau los ntsuas

1-3 batch pilot scale ntau lawm

Cim xeeb

3 validation batch ntau lawm

ICH Stability txoj kev kawm

Clinical Sample ntau lawm

[Analytical Development]

Kev txhim kho ntawm cov txheej txheem analytical ntawm cov khoom muaj feem xyuam thiab kev soj ntsuam

Kev kawm impurity

Kev loj hlob ntawm txoj kev tshuaj ntsuam xyuas: GC, IC, amino acid tsom xam, counter ions thiab kev tu cev

Kev tsim tshwj xeeb

Kev Npaj Ua Haujlwm

Validation ntawm analytical method

[Cov ntaub ntawv kev cai]

Cov ntsiab lus ntawm cov ntaub ntawv thiab DMF sau

Kev Tswj Xyuas Kev Pabcuam nyob rau pem hauv ntej ntawm US FDA / EDQM