Immunogenicity plays a critical role in the development of modern therapeutics, particularly biologics, vaccines, gene therapies, and immunomodulatory drugs. While these therapies offer significant clinical benefit, they can also trigger immune responses that may impact safety, efficacy, or pharmacokinetics. Understanding and managing these responses early is essential for successful drug development.
United Pharmaceuticals delivers end-to-end immunogenicity testing and bioanalytical solutions designed to support informed decision-making from preclinical research through late-stage clinical trials. Our scientific teams design fit-for-purpose immunogenicity strategies aligned with your molecule’s mechanism of action, study objectives, and regulatory expectations.
Every immunomodulatory therapy presents a unique biological profile. Differences in molecular structure, target engagement, dosing regimen, and patient population require customized immunogenicity assessment plans.
Our experts work closely with sponsors to define appropriate bioanalytical strategies, including:
We support programs involving oncology, autoimmune disorders, infectious diseases, metabolic conditions, and vaccine development, including studies requiring the handling of pathogenic or infectious samples.
Immunogenicity evaluation focuses on identifying and characterizing immune responses directed against a therapeutic product, including the detection of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs).
United Pharmaceuticals provides comprehensive support across all stages of immunogenicity testing, including:
Immunogenicity assays often face challenges due to matrix effects and biological interference. Our teams have extensive experience identifying and mitigating these issues using scientifically robust approaches.
We routinely address interference arising from:
Mitigation strategies may include acid dissociation, affinity capture elution, solid-phase extraction, physical separation techniques, or magnetic bead-based methods, selected based on molecule characteristics and study phase.
For early development programs, United Pharmaceuticals offers immunogenicity method qualification or validation tailored to study objectives and regulatory expectations. Qualification typically includes evaluation of key performance parameters using reduced replicates, while validation provides a more comprehensive assessment suitable for GLP studies.
Assay design is customized to balance scientific rigor with program timelines.
As programs progress into clinical development, immunogenicity assays must meet stringent regulatory requirements. Clinical assays are developed and validated to achieve appropriate sensitivity, specificity, and robustness, even in complex disease-state matrices.
We support studies across diverse populations, including healthy volunteers, ethnobridging cohorts, and patients with chronic or immune-mediated conditions. Our experience allows us to address challenges related to limited access to disease-specific matrices while ensuring assay performance remains representative and defensible.
Immunogenicity assessment is not a standalone activity—it is an integral part of a successful bioanalytical strategy. United Pharmaceuticals combines scientific expertise, advanced analytical platforms, and regulatory insight to deliver reliable immunogenicity data that supports safe and effective drug development.
Partner with our team to design immunogenicity solutions that reduce risk, strengthen regulatory submissions, and accelerate your program from early development through clinical success.