Elisa Development

ELISA Development Services

PHARMout offers ELISA assay service which includes Assay Development, Assay Validation, and Sample Analysis. Our Assay Development comes with custom antibodies or antigens, such as PD-1 Ab, PD-L1 Ab, PD-1 and PD-L1, which are validated in accordance with the FDA Bioanalytical Guidance.

Our expertise specifically aligns with our capability to implement a variety of sample tests tailored to our customer’s needs.

ELISA Development Services:

 • Meet the regulatory requirements by the customer
• Obtain the antibody or antigen supplied by the customer or commercial vendor
• Recommendations for appropriate control samples if requested
• Determine the dilution factor of the antibody and analyte and perform antibody
   conjugation labeling
• Define the dilution factor for the samples, standards and controls
• Specify incubation times and temperatures
• Specify acceptance criteria based on data analysis
• Perform a sensitivity analysis
• Perform a Precision Analysis
• Determine Lower Limits of Detection and Quantitation
• Determine Upper Limits of Detection and Quantitation

ELISA Validation Services:

• Create a validation protocol using the information provided by the customer and
   the QA unit.
• Document all sample requirements, such as blinding, procurement,
   accessioning, testing, storage, and retention.
• Perform validation testing in accordance with the Validation Protocol.
• Report validation results and provide a summary report that includes data
   analysis.
• Comply with the GLP requirements or specified by the customer.
• Comply with customer-defined qualification requirements, such as supplier
   audit.