[Proteintech] cGMP Grade Humankine Cytokines & Growth Factors

Proteintech cGMP 등급 사이토카인과 성장인자 단백질 배너

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.
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