ELISA and MSD Immunoassays within Ligand Binding Bioanalysis
Emery Pharma’s Immunoassay deliver scientifically rigorous and regulatory-ready quantitation of large molecule therapeutics and biomarkers across preclinical and clinical studies. Specializing in ligand binding assay (LBA) services, our team develops, transfers, and validates tailored immunoassays such as PK quantitation of monoclonal antibodies and ADC, PD biomarker monitoring and translational biomarker validation, biosimilar comparability, and Immunogenicity (ADA and nAb). Emery Pharma’s LBA services support clients with critical decision-making in drug development, from early pharmacokinetics to clinical sample analysis and regulatory filings.
Our comprehensive offering spans both traditional ELISA development and validation and multiplexed assays on the Meso Scale Discovery (MSD) platform, ensuring flexible solutions for single-analyte and multi-analyte quantification. With deep expertise in biomarker quantitation assays, plasma/serum biomarker testing, and custom assay design, we help biopharmaceutical sponsors mitigate risk, streamline study execution, and generate high-quality data that stand up to regulatory scrutiny.
Immunoassay Development and Validation Services
Emery Pharma provides end-to-end immunoassay development, optimization, and validation using ELISA and MSD platforms for large molecule quantitation and biomarker analysis. Our assay workflows are tailored to the analyte, matrix, and study phase, ensuring reliable performance and regulatory-ready data across preclinical and clinical programs.
ELISA Development and Validation
Description
Emery Pharma provides custom ELISA development and validation services to quantify large molecules and biomarkers in biological matrices such as plasma, serum, urine, and tissue homogenates. Our ELISA assays are designed to meet the sensitivity and specificity needs of your program.
Methodology
Using state-of-the-art plate reader and following ICH M10 (LBA validation) and FDA/EMA bioanalytical method validation guidances, we develop, optimize, and validate ELISA methods tailored to your analyte and matrix. Our bioanalytical scientists ensure robust performance across dynamic range, precision, and accuracy criteria required for preclinical and clinical data.
Deliverables
- Fully developed and optimized custom ELISA method
- Bioanalytical method validation reports in compliance with regulatory guidances
- Standard operating procedures (SOPs) and assay performance summaries
- Data ready for regulatory submissions and audits
MSD Assay Development and Validation
Description
Our MSD assay services offer sensitive, multiplexed immunoassay solutions for quantifying biomarkers and large molecule therapeutics. The MSD platform enables higher throughput and expanded dynamic range compared with traditional single-analyte approaches.
Methodology
Emery Pharma’s MSD development and validation workflows leverage the Meso Scale Discovery (MSD) electrochemiluminescence platform under ICH M10 (LBA validation) and relevant FDA/EMA guidances. We customize multiplex U-Plex and V-Plex panels to your biomarker and analyte profile, optimizing assay conditions to deliver precise, reproducible results across multiple targets.
Deliverables
- Custom MSD assay design and development
- Validation datasets and performance characterization
- Multiplex panel documentation and SOPs
- Regulatory-ready reports supporting large molecule quantitation
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Our Scientists
Dr. Prajita Pandey, Ph.D. is an analytical chemist and Associate Director at Emery Pharma, where she directs advanced method development and validation strategies for pharmaceutical products. With extensive experience in the structural characterization of complex large molecules, Dr. Pandey advises on the critical quality attributes of monoclonal antibodies, ADCs, and peptides. She ensures that all validation protocols—whether for characterization or quantitation—adhere to ICH and FDA guidelines, helping sponsors generate robust data packages for their preclinical and clinical programs.
News & Blog Articles
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average lead time for study initiation
response time to new requests
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Applicable Standards
ICH M10 (LBA validation), FDA/EMA bioanalytical method validation guidances
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Target Product / Molecule Type
Biologics, Peptides, Proteins, Biomarkers
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Instrumentation & Analytical Platforms
96-well microplate reader, Meso Scale Discovery (MSD)
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Sample Requirements
Variable depending on target analyte and dilution. Generally between 20-200 µL per run.
Why Choose Emery Pharma for Immunoassay Bioanalytical Services
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GLP/GMP Compliance
Emery Pharma adheres to stringent compliance standards, ensuring that ELISA and MSD assay data meet expectations for regulatory submissions and inspections across bioanalytical programs. -
Regulatory Expertise
Our team is deeply familiar with ICH M10 (LBA) and FDA/EMA bioanalytical validation guidances, providing strategic assay design and validation plans that align with regulatory requirements for large molecule quantitation and biomarker endpoints. -
Breadth of Instrumentation and Methodologies
With both plate reader-based ELISA and MSD platform capabilities, we deliver flexible solutions from simple single analyte assays to complex multiplex panels, tailored to your study needs. -
Cross-Industry and Multi-Molecule Experience
Dedicated project management and optimized workflows for ELISA development and validation and MSD assay service ensure efficient progression from method concept to validated data. -
Cross-Industry Experience
Trusted by pharmaceutical and biotechnology sponsors, Emery Pharma brings cross-industry insights that enhance assay design, data quality, and study success across preclinical and clinical bioanalysis.
State-of-the-art instruments used in immunoassays.
ELISA and 96-well microplate reader, Meso Scale Discovery (MSD)
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Frequently Asked Immunoassay Questions
What is the primary difference between ELISA and MSD platforms?
While both are immunoassays, the difference lies in the detection method. ELISA (Enzyme-Linked Immunosorbent Assay) typically uses a colorimetric or fluorometric readout. MSD (Meso Scale Discovery) uses Electrochemiluminescence (ECL). MSD offers significantly higher sensitivity, a broader dynamic range, and the ability to multiplex up to 10 analytes in a single well.