최근 임상 시험의 증가로 safety, purity, stability가 검증된 재조합 단백질 제품에 대한 수요가 증가하고 있습니다. Proteintech의 HumanKine® 단백질은 xeno-free, animal component-free일 뿐만 아니라 ISO13485 인증을 받았으며, GMP를 준수하여 생산하므로 임상 응용에 이상적입니다.
“For Humans… By Human Cells”
HumanKine HEK293-expressed human proteins
- Animal component free
- Tag, xeno and endotoxin free
- Authentic human proteins
- Native human folding & glycosylation
- High purity & activity
- Manufactured in the USA
cGMP Grade Cytokines & Growth Factors
Proteintech is ISO13485 certified and our cGMP Policy ensures:
- ISO13485 certified
- Regulatory compliance: USP <1043>, Ph. Eur. 5.2.12, WHO TRS, No. 882, 1992 Annex 1
- Quality check at every step of production
- ISO rated clean rooms for manufacturing and filling
- Animal component free and Xeno free production process
- Regulatory support and Facilitiy available for on site audit
Documents for cGMP grade proteins
Documents available on request
- Certificate of Analysis (COA)
- Certificate of origin (COO)
- Sterility certificate
- BSE/TSE statement
- Viral testing certificate for Master cell bank
- Drug Master Files- filing in progress.
Proteintech is ISO 13485:2016 certified and our GMP HumanKine products are manufactured and tested in accordance with the relevant sections of the following standards:
- USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Ph. Eur. General Chapter 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products
- Sterility testing according to USP <71>.
- Mycoplasma testing according to USP<63>.
- Bacterial endotoxin test according to USP<85>.