Precision develops cell-based assays in both 2D and 3D formats across a broad range of human primary cell types. Our assays have provided data supporting a range of different therapeutic indications from diabetes to fibrosis and oncology, but our primary focus remains in anti-inflammatory and autoimmune research. Our customized approach develops fit-for-purpose assays to the specific needs of your program. In addition to assay development, our breadth of analytical platforms enable us to deliver a comprehensive range of assay endpoints, including mediator/cytokine release, changes in gene expression, ICC, and high content cellular imaging.
Cell-Based Assays Customized to Your Program
Example Cell Types Used for Assay Development
- Blood – PBMC, monocytes, lymphocytes, neutrophils, monocyte-derived macrophages
- Skin – keratinocytes, fibroblasts
- Lung – bronchial epithelial cells, alveolar macrophages, alveolar type II cells, smooth muscle cells, tumor epithelial cells, cancer-associated fibroblasts
- Liver – hepatocytes, Kupffer cells, stellate cells
- Other – pancreatic islets, synovial fibroblasts
- 2D – multiwell plates
- 2D – transwells
- 3D – spheroid
- 3D – air-liquid interface
- 3D – OrganDOT matrix-free aggregates
- 3D – RAFT physiological density matrix
Cell-Based Assay and Endpoint Types
- Cytokine – mediator release
- Cell viability/proliferation
- Changes in gene expression
- Enzyme activity/release
- Barrier permeability
- Cell migration
- Multiplex immunofluorescence / high content cellular imaging
Case Study: Bioassay Validation Supporting EMA Marketing Authorization Application
Precision developed and fully validated a human primary cell-based assay for screening anti-TNFα biosimilars.
- 2D assay
- Synovial fibroblasts from rheumatoid arthritis donors
Assay development included:
- Reference standard inhibitor
- Titration of stimulus
- Selection of sentinel marker
- Formulation effect
Assay validation included:
- Linearity and range
- Relative potency
- Precision – intra/inter assay
- Biosimilar screen
Precision also performed a biosimilar screen comparing relative potency versus Humira.
Integrating biomarker and clinical trial data
To help researchers understand and interpret biomarker assay data in the context of other assays as well as the clinical trial data, Precision manages all assay data using our proprietary QuartzBio Translational Informatics platform.
Learn more about the sample management, informatics, and computational capabilities of QuartzBio.
Global Reach, Multi-site Support
We provide tissue cross-reactivity services that support preclinical research conducted anywhere in the world.
Working with Precision
Precision’s specialty lab scientists take a collaborative and consultative approach to projects and can provide recommendations on biomarker assay strategies and implementation. Services can be provided individually or as part of a comprehensive therapeutic development package, including biomarker assays and clinical trials.
Precision’s immunohistochemistry (IHC) services can be customized based on study needs, and can include development of logistical processes, kitting, special stains, and creation of a custom assay and scoring system.
Flow cytometry provides high-dimensional insight into immune cells and target engagement. We have both research-grade instruments for up to 20 parameters analysis and CLIA instruments, all supported by a global sample processing and logistics network to ensure sample integrity.
We offer automated multiplex immunofluorescence (mIF) services that enable quantitative visualization of as many as 9 markers in tissue and liquid biopsies, and individual cells. mIF can be integrated with other methods including co-analysis using fluorescent in situ hybridization/in situ hybridization (FISH/ISH).