Cell and gene therapies (CGT) and advanced therapy medicinal products (ATMP) require sophisticated approaches to characterization and release testing. Solvias has extensive expertise in this specialized area, from physicochemical characterization to biosafety and product release testing in a regulated cGMP environment.
Our comprehensive technical capabilities include:
from raw material testing, cell culture media-specific analysis, and oligonucleotide analytics to vector characterization.
including high-resolution LC-MS/MSMS, SEC-AF4-MALS Platform, and FT-IR under GMP, offering the sensitivity for patient-specific release testing.
the gold standard in RNA/DNA filling degree analysis for AAV cGMP release testing.
using ddPCR coupled with Cergentis’ Targeted Locus Amplification (TLA) technology.