Operational Innovation
In the summer of 2021, IQVIA Laboratories opened a new state of the art, custom designed laboratory space, known as IQVIA Innovation Laboratories. Located on the new IQVIA Innovation Park Campus, in the heart of the dynamic Research Triangle Park in central North Carolina, this facility creates an innovative scientific community that includes multiple laboratory disciplines from service lines including Large Molecule Bioanalytical, Vaccines Center of Excellence, Genomics Center of Excellence and Translational Science and Innovation Laboratory (TSAIL).
With scientific thought leaders from anatomic pathology, flow cytometry, genomics, vaccine development, and large molecule bioanalytical services under one roof IQVIA Laboratories is well poised to engineer solutions for sponsors that will support our mission to turn patients’ hope into the help they need.
Genomics and Bioinformatics Center of Excellence
IQVIA Laboratories industry-leading genomic, molecular, and bioinformatics services provide customers with global testing to support clinical research and precision medicine, from discovery to late phase trials and companion diagnostic development. IQVIA Laboratories works with clients, using a wide array of innovative technology platforms including next generation sequencing and targeted biomarker testing to ensure maximum efficiency and quality delivery for every study.
Our genomics and bioinformatics services provide DNA and RNA sequencing and other molecular testing to support drug discovery, translational medicine, clinical development, and precision medicine including companion diagnostics.
The following are some of the key features of our new genomics laboratory:
- Double the amount of core laboratory square footage
- Increase in capacity and fleet size in key areas such as biorepository, Biosafety Cabinets, and automation
- Colocation with IQVIA Laboratories Specialty Sciences such as Large Molecule Bioanalytical, Vaccines, and TSAIL allows for an expanse of scientific thought leadership available for collaboration
Large Molecule Bioanalytical Laboratory
Our large molecule bioanalytical laboratory develops custom PK concentration, biomarker and anti-drug antibody/immunogenicity assays in support of all phases of drug development. Validation follows bioanalytical method validation guidance as applicable to ligand binding methodology. These assays are then put to action to support sample testing following a GLP/GCP quality system. Our laboratory also performs bioconjugation services and calculates statistical cut points in support of our sponsors.
The following are some of the key features of our new large molecule bioanalytical laboratory:
- Custom designed wet laboratory for optimized workflow, includes cell and genomics suites.
- 50% increase in capacity, significant and broad investments in automation, next generation immunoassay formats and increased fleet size.
- Colocation with IQVIA Laboratories Specialty Sciences such as Genomics, Vaccines, and TSAIL enables effective collaboration as we expand our cell and gene therapies support with bioanalytical flow cytometry and PCR services.
Vaccines Laboratory
Our vaccines laboratory offers standard and custom services to support vaccine, infectious disease, and immunogenicity testing, as well as assay technology transfer and de novo assay development and validation. Balancing the promise of emerging technologies with the current needs of our clients, IQVIA Laboratories anti-infective and vaccine development solutions include assay development, immunogenicity testing, genomic solutions, efficacy monitoring, project management and data management to meet your vaccine testing needs, whether it be product development or large-scale clinical trials. IQVIA Laboratories offering includes an active global footprint, proven supply-chain and quality-management systems, and decades of specialized experience enabling us to be an invaluable and responsive partner at every stage of the vaccine development lifecycle.
The following are some of the key features of our new vaccines laboratory:
- BSL-3 lab space permitting:
- Work with emerging infectious diseases (such as SARS-CoV-2)
- Work with select agents
- Work with wild-type plaque reduction neutralization assays
- Antiviral discovery work with infectious virus
- Expanded capacity for Ligand binding, neutralization, and PCR assays
- Cross disciplinary testing with TSAIL offering new capacities such as vaccine induced cell mediated immunity via ELISPOT and/or intracellular cytokine staining
Translational Science and Innovation Laboratory (TSAIL)
IQVIA Laboratories state-of-the-art translational science and innovation laboratory (TSAIL) is designed to accelerate the drug development process with advanced laboratory capabilities spanning biomarker discovery through next generation vaccine, genomic and bioanalytical sciences, outside the regulatory confines of clinical trials. IQVIA Laboratories dedicated team of cross-disciplinary translational scientists work with clients to provide early access to technology-driven research and innovation as well as support early assay development to ensure better patient outcomes.
This previously unmet industry need will enable new technology evaluation and support early biomarker development to facilitate adoption of assays into clinical trials and advance the development of companion diagnostic tests to better impact patient outcomes.
The following are some of the key features of our new TSAIL laboratory:
- Exclusive focus on human biomarker discovery activities and exploratory clinical sample testing
- New technology and innovation evaluation and method comparison studies
- Fit for Purpose validation
- Integration of AI/ML and Informatics assisted analytics
- Testing focused on Genomics, Flow Cytometry, Anatomic Pathology, Immunoassays