Custom Development Capabilities

Cell-based assays are valuable tools employed throughout the drug discovery and development phases and into commercial release and stability testing. Implementing cell-based assays for in-house custom assay development can be challenging, from establishing physiological relevancy to method qualification, validation, post-implementation, and support. Phase-appropriate assays, in particular, can be technically challenging, expensive, and resource-intensive, delaying moving programs forward to the clinic.

Eurofins DiscoverX® offers the industry’s most extensive off-the-shelf menu of cell-based assays that can be implemented for your programs. Several customized solutions can be delivered for program-specific needs by utilizing our deep expertise in cell line engineering, assay design, method qualification, and cell and protein production. Some solutions include engineering a cell line with a different cell background, target, or cell model; developing an assay with a unique mechanism of action (MOA); or creating a ready-to-use bioassay qualified with your clinical molecule.

Gain from our experience leveraged over 20 years of custom development expertise and a vast history of generating thousands of customized assays for drug discovery programs at multiple companies globally through screening, lead optimization, and bioanalytical assay development.

Product Highlights
  • Development Expertise – Decades of cell-based assay development, cell line engineering, and recombinant enzyme development expertise
  • Cell Line Engineering Capability – Exogenous expression approaches or gene editing
  • Collaborative – Consultative product development with regular updates through a dedicated project manager
  • Complete Solution – Customized assay development with screening and profiling services within the same team
CONTACT CUSTOM DEVVIEW VIDEO

Highlights

Key Custom Development Capabilities

  • Cell line engineering through exogenous expression (constitutive vs inducible) approaches, gene editing (e.g. KO/KI with CRISPR/Cas9), or retroviral or lentiviral transduction
  • Bioassay development and International Council for Harmonisation (ICH)-based method qualification
  • Screening (high and ultra-high throughput), characterization, profiling, Investigational New Drug (IND)-enabling studies, and comparability studies
  • Membrane preparation development and production
  • Analytical Master Cell Bank (MCB) (critical reagents; bioassay cells) 2-tiered production
  • Bioassay method transfer to QC testing sites
  • Dedicated large lot or multiple lots production of ready-to-use cryopreserved cells
  • Protein development and production, including recombinant enzymes (active, inactive, unactive) and multi-subunit proteins

Custom Assay Development Project Workflow

Phase 1:
Project Definition		 Phase 2:
Project Execution		 Phase 3:
Material Delivery
  • In-Depth Consultation
    Define project goals and scope
  • Extensive Research
    Investigate and evaluate project feasibility
  • Deliverable
    Detailed work plan with timelines, project deliverables, and pricing
  • Cell Line Engineering
    Stable cell line development, functional testing, and stability testing
  • Assay Development
    Method optimization, detailed protocols
  • Screening and Profiling
    Test client’s molecules with catalog or custom assay
  • Deliverables
    Bi-weekly status updates and detailed milestone reports
  • Deliverables
    Assay format as per work plan with detailed protocol
    • Validated stable cell line
    • Qualified ready-to-use bioassay
    • Membrane preparations
    Study Reports
    • Bioassay ICH qualification
    • Comparability studies
  • Additional Options
    • Large lot production
    • Master Cell Bank
    • Method transfer to testing site