Growth factors and cytokines are types of signaling molecules that play a crucial role in regulating cell growth, differentiation, and function. They are widely used in research, preclinical studies, and clinical trials to study various biological processes and develop new treatments for diseases. The main difference between research use only, preclinical, and GMP areas is in the quality and documentation required for their manufacture and use.
Growth factors and cytokines for research use only (RUO) are produced for use in basic research and are not intended for diagnostic or therapeutic applications. They are typically manufactured using standard laboratory procedures and may not meet the stringent quality requirements necessary for clinical use. They are often used in academic research or commercial applications such as drug discovery, screening, and target identification.
CellGenix preclinical growth factors and cytokines are intended for use in the early development phase of cell & gene therapies. They are produced under the same conditions as the CellGenix GMP growth factors and cytokines, using identical production steps and expression systems. This ensures equal product quality and performance and enables a seamless transition when switching to the GMP grade growth factors and cytokines. Our preclinical grade, therefore, offers a cost-efficient alternative for preclinical phase when regulatory support and quality of raw materials have a lower priority and access to GMP-relevant documentation is not required yet.
CellGenix GMP growth factors and cytokines are manufactured under strict conditions in compliance with relevant GMP and global guidelines to meet the highest quality and safety standard for use in clinical trials and ultimately in patient treatment. The difference to CellGenix preclinical is that we offer regulatory support, and more comprehensive QC testing including tighter specifications and documentation.
In summary, the main difference between cytokines with a research use only, preclinical, and GMP quality grade is in the level of quality control and documentation, and their intended use.
RUO grade: intended for basic research
Preclinical grade: intended for preclinical ex vivo use
GMP grade: intended for ex vivo use in clinical trials and commercial ATMP manufacturing