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.