ADA Assay Development

Develop robust immunogenicity assessment strategies with Rockland’s comprehensive anti-drug antibody (ADA) assay development services. Our experts specialize in producing high-quality ADA positive controls to support the accurate detection and quantification of anti-therapeutic immune responses.

With over 25 years of experience partnering with leading biopharma companies, we deliver reliable, fully customized ADA assay solutions that help advance your biologic therapeutics toward regulatory approval and commercial success.

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Understanding ADA Assay Formats

ADA assays are designed to detect anti-drug antibodies (ADAs) and can be tailored using various formats depending on the therapeutic and detection requirements.

Our ADA Assay Development Process

Antigen & Immunogen Preparation

We utilize your therapeutic antigen or develop custom immunogens tailored to elicit a robust, specific immune response. Our process ensures the generation of high-affinity anti-drug antibodies capable of detecting subtle differences in drug binding.

Anti-Drug Antibody Generation

Using our in-house animal facilities, we raise anti-drug antibodies that serve as ADA positive controls or as assay reagents. Our flexible approach accommodates monoclonal, polyclonal, or recombinant antibody production, depending on your requirements.

Purification & Characterization

We employ a range of purification strategies—Protein A, Protein G, Protein A/G, and affinity purification—to achieve the desired specificity and purity levels. Each antibody batch can be tested to confirm its binding characteristics and stability.

Conjugation & Customization

To enhance detection capabilities, we offer a variety of conjugation options, including biotin, horseradish peroxidase (HRP), alkaline phosphatase, and a vatiety of fluorochromes. These customizable reagents help ensure your ADA assays perform optimally in ELISA or other assay platforms.

Our Antibody Capabilities

Our expertise extends beyond traditional anti-drug antibody generation. We also specialize in producing various antibody types to support a wide range of therapeutic development programs:

Anti-Antibody

Anti-Protein

Anti-Oligo

Anti-siRNA

Addressing Immunogenicity in Biologics

Immunogenicity is a critical consideration in the development of biologics, such as therapeutic protein products. Immune responses to these protein-based treatments can significantly influence their pharmacokinetics, pharmacodynamics, safety, and efficacy.

Risk-based assessment: Different biologics come with varying immunogenicity risks. Employing a risk-based approach allows developers to prioritize testing strategies that are most critical for product integrity and patient safety.

Comprehensive ADA profiling: An effective immunogenicity testing strategy involves not only screening and confirmatory assays but also titer and neutralization assessments. These additional characterizations provide deeper insight into ADA implications.

Impact on drug performance: ADAs can alter a biologic’s distribution, metabolism, and clearance, affecting dose requirements and potentially reducing overall therapeutic benefit. Close monitoring of these parameters enables timely adjustments in treatment regimens.

Drug clearance: Understanding the frequency, magnitude, and clinical relevance of ADA responses is pivotal. These findings inform regulatory filings, prescribing information, and clinical decision-making, ultimately supporting a safer and more effective patient experience.

Addressing Immunogenicity in siRNA Therapeutics

As the field of siRNA-based therapies continues to expand, so does the need for rigorous immunogenicity assessments. Anti-drug antibodies (ADAs) have the potential to alter the efficacy, safety, and pharmacokinetics of siRNA drugs, making reliable analytical tools essential for managing these emerging challenges.

Immune-mediated adverse events: The formation of immune complexes between ADAs and siRNA may trigger unwanted immune responses, such as inflammation or other side effects.

Reduced efficacy: ADAs can bind to siRNA, preventing it from reaching its target or silencing the gene effectively, which can lead to a decrease in therapeutic benefit.

Altered pharmacokinetics (PK): ADAs might change the distribution or metabolism of the siRNA, potentially leading to altered drug levels and necessitating adjustments to dosing regimens.

Drug clearance: ADAs can also enhance the clearance of siRNA from circulation, potentially reducing the duration of its therapeutic effects.

Supporting Reagents

To further optimize your ADA assyas, Rockland provides a wide range of supporting reagents that enhance assay performance, including detection antibodies, substrates, stablizers, and bocking buffers:

Product	Usage
Human IgG Fc Antibody	Capture & Detection
Human IgG Fc Antibody Biotin Conjugated	Capture
Chemiluminescent FemtoMax™ Super Sensitive HRP Substrate	Substrate
TMB ELISA Peroxidase Substrate	Substrate
TMB Prestained Red ELISA Peroxidase Substrate	Substrate
ELISA Coating Stabilizer	Stabilizer
HRP Conjugate Stabilizer	Stabilizer
ELISA Microwell Blocking Buffer with Stabilizer	Stabilizer + Blocking Buffer
Blocking Buffer for Fluorescent Western Blotting	Blocking Buffer
Blocking Buffer (2X) for Fluorescent Western Blotting	Blocking Buffer
10X BBS Fish Gel Concentrate	Blocking Buffer
10X PBS Fish Gel Concentrate	Blocking Buffer
10X TBS Fish Gel Concentrate	Blocking Buffer

Interested in ADA assay development services?

We can help move your program forward—contact us to find out how.

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