In order to meet the growing demand for our consumables in clinical use, a cell therapy grade product line was necessary and the next logical development for the company. We will now provide the new quality grade with extended quality controls, documentation, and traceability information in line with industry regulatory standards CFR21-Part 210 and USP<1043>. With this customized and high safety profile approach to serving customers, we have innovated in solving unique manufacturing challenges such as cell yield, process time and cell quality.
“We’ve made an investment in developing CTG consumables as we’ve seen a key opportunity in the market. There are simply too few existing options for customers looking for safe, high-performance products for clinical trials – with current international supply chain conditions, this is especially true. We aim to give cell manufacturing organizations an alternative that’s safe, available and compliant.’’ says Dr. Richard Wetzel, Managing Partner of denovoMATRIX.
Read more here: https://www.denovomatrix.com/cell-therapy-grade/