JYMed nwere ike inye peptides ' API na peptide okokụre onunu ogwu mmepe maka gị oru ngo, dị ka n'okpuru:
[mmepe mmadụ]
CQA
QBD
Development na mkpebi siri ike nke usoro
Optimization nke usoro
3 batches mmepụta na-amata ndị feasibility n'ọtụtụ elu
1-3 batches pilot ọnụ ọgụgụ mmepụta
akparamagwa
3 nkwado batches mmepụta
Ich Kwụsie ọmụmụ
Clinical Sample mmepụta
[Gbasara nyocha Development]
Development nke gbasara nyocha ụzọ nke yiri umi na nnwale
adịghị ọcha ọmụmụ
Development nke gbasara nyocha ụzọ: GC, IC, amino acid analysis, counter ion na idebe ihe ọcha na usoro
Establishment of nkọwapụta
Ọrụ Standard Nkwadebe
Nkwado nke gbasara nyocha usoro
[Akwụkwọ iwu]
Nchịkọta nke data na DMF ndochi
Regulatory Support n'ihu US FDA / EDQM