High-resolution GMP-certified analytics for Gene Therapy Medicinal Products (GTMPs), ensuring the safety, purity, and potency of viral delivery systems.
Viral vectors (AAV, Lentivirus, Adenovirus) are the biological engines of modern gene therapy. Their structural complexity demands a specialized analytical approach that spans molecular biology, biochemistry, and virology.
BrownBiology Laboratory provides a comprehensive GMP-certified platform for the characterization of viral vectors. We leverage advanced platforms like Droplet Digital PCR (ddPCR) and High-Resolution Mass Spectrometry to provide the definitive analytical data required for regulatory submission.
Talk to the Gene Therapy Team 鈫?/a>
Defending the integrity of your therapeutic payloads from process to product.
Precise quantification of viral genomes using qPCR and ddPCR platforms, combined with identity confirmation of therapeutic genetic payloads.
Assessment of total capsid concentration and empty/full ratio analysis through ELISA and specialized chromatographic techniques.
Detection of host cell proteins (HCP), residual DNA, and process-related impurities using high-sensitivity MS and bioanalytical modules.
Functional characterization of viral vector infectivity and transgene expression through standardized cell-based bioassays.

Our facilities are uniquely equipped to handle the specific safety and containment requirements for viral vector manipulation. From early characterization to stability testing and global batch release, BrownBiology Laboratory is your trusted partner in gene therapy innovation.