Cytokiny a media GMP kvality
High Quality- High Performance from Research to ATMP
GMP Quality raw materials for ATMP manufacturing: Human cytokines, growth factors, and other recombinant cell culture components in preclinical abd GMP quality as well as proprietary serum-free media for further manufacturing of ATMPs.
GMP grade products allow for the safe use in clinical trials and commercial manufacturing in accordance with the guidelines set by the (FDA) Food and Drug Administration and the European Medicines Agency (EMA).
Cytokines – Animal-Derived Component-Free Policy
Media – Serum-Free Policy
Preclinical and GMP grade cytokines: Both product grades are produced under the same conditions in a GMP facility, using identical production steps and expression systems. This ensures an equal product quality and performance.
The difference between both quality levels is that we offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products. Our preclinical grade products therefore offer a cost efficient alternative for the early development phase when safety and quality of raw materials have a lower priority.
Preclinical grade: Intended for preclinical ex vivo use
GMP grade: Intended for ex vivo use in clinical trials and commercial ATMP manufacturing
More info: www.cellgenix.com