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Assay Development


 

Assay Development Services

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

LOD, LLOD

Specificity

Reproducibility

LOQ, LLOQ

Matrix Effects

Robustness

Accuracy

Reference Standards

Recovery

Precision

Linearity

 

 

 

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

 

 

Dilution

 

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:

 

Get a Quote

 

 

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