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A dedicated partner that you can rely on. We deliver what we say we will, when we say we'll deliver it and work with you to meet your bioassay requirements.

 

We offer a comprehensive range of bioassays tailored to your needs and delivered by experts at an affordable cost, with quick, transparent service and a guarantee of robust data and analysis that will power your product through development.

Our GLP compliant, bioassay testing services deliver end to end support from preclinical phase to licensing and commercial stages of your biopharmaceutical drug development project:

  • Assay feasibility
  • Assay design and development
  • Assay qualification & validation
  • Sample analysis (cGMP lot release and characterization)

State-of-the-art cell-based assay facilities are run by a veteran team of highly experienced scientists well-versed in the quality and regulatory demands of biological assay development to support your innovation in the areas of biologics and biosimilars.

Cell based bioassays

Cell based assays are designed to assess the mechanism of action (MOA) and relative potency of your drug by rigorous statistical methods. Our cell based services includes:

  • Reporter gene
  • Neutralization
  • ADCC/CDC
  • Receptor activation
  • Proliferation
  • Cytotoxicity

Our test platform includes: Absorbance, Fluorescence, Luminescence, HTRF, TRF, Alpha Lisa.

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Ligand binding assay

Ligand binding assays are employed to characterize the receptor binding properties of your biotherapeutics. We offer biolayer interferometry services to evaluate the binding affinity of your biologic.

Residual impurity testing

The immunogenicity of a biologic must be evaluated as it impacts drug efficacy. We have developed and qualified a host cell protein and DNA assay to determine the safety of your drug. Our platform includes: HCP, HCD, SCP, Trypsin.

Cell banking services

Stelis offer cell banking services to ensure quantity and consistency in your development programs, validation, stability and lot release testing. Our cell banks are tested for sterility and stored in liquid nitrogen and monitored continuously.

Stability/lot release testing

Stelis provides sample analysis services for stability and lot release from a cGMP compliant facility, delivering the results quickly to support fast release to market.

Biosimilarity

Our testing services demonstrate that a proposed therapeutic protein product is biosimilar to the reference product with rigorous statistical analysis and representation.