The use of alternative treatments such as Cell and Gene Therapies (CAGT) holds great potential for bridging the gaps left by traditional treatments. These innovative CAGT clinical development programs require a suite of complex laboratory assessments to satisfy regulatory submissions and support Proof of Mechanism, Pharmacodynamic, Safety and Efficacy investigations. Q2 Solutions, with its global laboratory network and industry leading subject matter experts, is ideally positioned to shape, validate, and deliver those biomarker assessments. In partnership with IQVIA and IQVIA Biotech, Q2 Solutions can provide flexible, integrated Cell and Gene Therapy development solutions throughout the drug development journey, beginning with the pre-clinical phase and continuing through post-approval.
We quickly design and validate potential therapeutics and can accommodate early safety testing with specialized assays, including ddPCR, Next Generation Sequencing and single-cell portfolio.
We offer not only laboratory testing but also expertise in the design, validation, and choosing the correct assay for your specific need.
We develop customized assays in our North Carolina laboratory and transfer them seamlessly to Beijing and other laboratories around the world.
We are connecting across the organization and applying our collective intelligence to solve the most pressing challenges facing CAGT sponsors.
In just one example, a CAR-T therapeutic (YESCARTA) was approved by the FDA in 2017. An additional clinical study was set up in China in 2018 and was awarded to Q2 Solutions.
Category | Biomarkers | Matrix | Method |
PK | CD19 CAR-T cell expansion | PBMC | qPCR |
ADA | anti-FKC876 antibodies | Serum | ELISA |
RCR monitoring | RCR performed on PBMC samples | PBMC | qPCR |
Biomarkers | IL6, IL 15, IL1ra, IL2Rα, IFNγ, IL10, IL 8, MCP-1, IL2, GM-CSF, TNFα, IP-10, VCAM-1, Granzyme B | Serum | MSD |
CD19, CD20, PD-L1 | FFPE | IHC |
Talk to us about how we can help speed your cell and gene therapies to patients who need them.
The use of alternative treatments such as Cell and Gene Therapies (CAGT) holds great potential for bridging the gaps left by traditional treatments. These innovative CAGT clinical development...
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