Cell and Gene Therapy (CAGT)

Cell and Gene Therapy (CAGT)

Providing industry-leading science and innovative laboratory solutions across the CAGT spectrum

Expert services to stay ahead of advancing science

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.

Q2 Solutions offers an extensive array of CAGT laboratory solutions to meet the unique demands of CAGT clinical development

Gene and Cell Therapy

Industry-Leading Technology and Expertise with a Global Footprint

Genomics technology


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.


Thought leadership



We offer not only laboratory testing but also expertise in the design, validation, and choosing the correct assay for your specific need.


Global assays

assay - Copy

We develop customized assays in our North Carolina laboratory and transfer them seamlessly to Beijing and other laboratories around the world.



Winning the successful approval of CAR-T in China

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.


  • Study title: An Open-Label Clinical Study for Evaluating the Safety and Efficacy of FKC876 in the Treatment of Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
  • Phase 1-2 (bridging study)
  • Enrollment: 15.
  • Indications: R/R large B cell lymphoma, including DLBCL, PMBCL, HGBCL, TFL.
  • Primary endpoint: DLT, ORR
  • Secondary endpoint: AE, PFS, DOR, OS
  • Exploratory endpoint: FKC876 expansion and persistence in blood and correlation with efficacy; PD marker and predictive biomarker correlation with efficacy; FKC876 expansion/PD marker correlations with CRS and neurotoxicity; gene mutations correlations with efficacy. 


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


Talk to us about how we can help speed your cell and gene therapies to patients who need them. 

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