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Assay Development


Rockland's full-service immunoassay development service bridges the path from discovery to product. Rockland's scientific expertise provides highly customized solutions to meet your basic, applied and clinical research demands in the development of unique in vitro assays.

To enable innovative biomarker development for drug discovery and diagnostic applications, we offer highly customized solutions. From the generation of highly specific antibodies to the development of unique in vitro assay systems, Rockland is your partner by providing scientific expertise for your biomarker evaluation and bioassay development needs. Our services include: Assay Development, Assay Qualification, Assay Validation, and Lot Release Testing and other related supporting services such as accelerated stability studies, antigen production and antibody development.




Custom Antibody Development



Assay Development

Rockland assay development services offers high quality bioanalytical assays supporting:

Companion and In vitro diagnostics
• Novel biomarker assays
Host Cell Protein assays
• Bridging Studies

As a partner Rockland will collaborate to define and develop user-defined specifications, which become the basis for designing immunoassays that meet or exceed your project goals. The development of specific immunoassays can form part of an antibody development project or can be initiated using existing assay-specific reagents supplied by the client.

• Fast Turnaround 3-4 months
• Scientific Expertise PhD and Industry experience

A unique strength at Rockland is our antibody generation and development capabilities. Novel assays can be created start to finish by leveraging our in-house monoclonal and polyclonal antibody generation services with assay development. This synergy allows for generation of all critical assay reagents throughout the assay development process. 

For all assay development services and information requests please inquire with one of our experts.


Dan Kenney

Director, Scientific Business Development

(484) 791-3823

Contact Us



Assay Qualification

Rockland can demonstrate that an accepted method provides meaningful data for specified conditions.


• Matrix effects
• Process specific samples evaluations
• Suitability of the protocol under actual performance conditions


Assay Development Flow



Assay Validation

• Comprehensive experimental performance
• Evaluation and documentation of the assay quantitative performance


Assay Validation Performance Parameters





Matrix Effects



Reference Standards







Lot Release Testing

Rockland offers quality control testing on reagents from individual production lots. This ensures purity, activity, stability, and performance

QC testing is available on:
• Raw materials
• Unprocessed bulk
• Purified bulk
• Filled finished products

Examples of Immunoassays

 Assay Binding Performance


Comparison of Capture-Detection Antibody Pairing
The result for this assay was that background and variability of blocker 1 incubated at room temperature for 2 hours were lowest compared to other blockers. 



Comparison of Capture Antibodies by Direct ELISA


Plates were coated with a serial dilution of antigen and probed with several capture antibodies.  The lead capture antibody has a limit of detection below 100 pg.




Comparison of Capture Antibodies





Cell-based fluorescent ELISA

Adherent epithelial cells were fixed onto a plate and probed with primary antibody anti-GAPDH and detected by a secondary DyLight 488 coupled antibody.



Blocking Solutions Testing




Comparison of several blocking buffers and time of blocking to optimize the ratio signal to noise.

The result for this assay was that background and variability of blocker 1 incubated at room temperature for 2 hours were lowest compared to other blockers.



You can acquire or obtain a quote from any assay development service here:


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Related Products and Services:

Custom Antibody Production
Cell Culture Services
In Vitro Diagnostic Services and Solutions 
Purification Services
Secondary Antibodies
Blocking Buffers
Enzyme Substrates


Rockland Assay Development Figures:

Assessment of Antibody Stability (pdf)
Cell Proliferation/Death Studies (pdf)
Screening of Candidate Antibodies (pdf)
US FDA Guidelines for Bioanalytical Validation


View All Custom Services




The Rockland Advantage - Quality

At Rockland, we understand that our antibodies and services allow critical R&D that may lead to future therapeutic treatments, cures for diseases, and diagnosis of unknown ailments. We also know that the researchers using our products depend on quality and consistent results.


Assay Development Assay Validation Assay Qualification Lot Release Testing