Functional Assays

At EAG Laboratories we offer our clients best in class technical expertise coupled with use of cutting edge instrumentation. From IND enabling studies through commercialization our Bioassay Teams provide services to support the highly-specialized assays needed to assess the functional abilities of a Drug Product. Functional assays include cell based assays, ELISAs, binding assays and enzymatic assays.

Cell-based Assays

Cell based assays are among the most complex and sophisticated assays used to measure the biological activity of a molecule. Cell based assays are often the preferred choice to determine the activity of a compound, as they evaluate the physiological response of a product with the dividend of assessing functional activity. These assays are used throughout the development process; in early development as screening assays for viable compounds, in early phase product development and as validated assays.

• Potency assays
• Ligand Binding Assays
• Cytotoxicity & Cell proliferation assays, ADCC, CDC
• Apoptosis
• Cell Signaling
• Neutralizing antibody assays
• Toxin Neutralization assays
• Activation of cell signaling pathways (e.g. phosphorylation, ubiquitination)
• Cell migration assays
• Reporter gene expression assays, including B-galactosidase, Luciferase, Green fluorescent protein and Red fluorescent proteins

Cell Culture Services

• Derivation and characterization of cell lines and cell cultures
• Development of primary cell lines
• Generation of stable inducible cell lines
• Mycoplasma testing of cell cultures
• Cell Banking (in support of bioassays): Preparation, Characterization and Storage of Master and Working Cell Banks

ELISAs and Binding Assays

EAG offers a full portfolio of ELISAs including direct, indirect, sandwich, and competitive ELISAs. We have the capability to execute a wide range of high through put immunoassays assays using absorbance, fluorescence, luminescence, chemiluminescence, and electro-chemiluminescence endpoints.

EAG Labs offer a diverse array of binding assays designed to characterize and quantitate pharmaceutical and biotechnology products. We have the capability to execute a wide range of high throughput assays with single plex and multiplex capabilities using absorbance, fluorescence, luminescence and chemiluminescence endpoints.

ELISAs

• Antigen-specific antibody titers
• Antibody isotyping/subtyping
• Ligand Binding Assays

Immunogenicity

• Anti-Drug Antibody (ADA) Assays
  • Assay development
  • Screening and Confirmatory Assays
  • Neutralizing Antibody assays
• Protein Identification, Characterization and Quantitation
  • Enzymatic Assays
  • Protein Expression Assays for both mammalian and plant based systems
  • Western Blotting, Immuno-precipitation Assays
• Quantitation of Impurities
  • Host Cell Protein ELISAs
  • Residual Protein A Analysis

Characterization

• Two-dimensional gel electrophoresis/Western Blotting to assess immunocoverage
• SDS-PAGE, Agarose for protein and DNA

Enzyme Assays

Assays to study enzyme-catalysed reactions are vital for the study of enzyme kinetics and inhibition, and to assess potency of a drug product. EAG scientists possess deep experience in the development and performance of enzymatic assays to assess purity, enzyme activity, specific activity and % purity using multiple platforms, including fluorescence, absorbance, luminescence, chemiluminescence and electro-chemiluminescence.