On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
As a world-leading authority in the field of immunogenicity testing, BioAgilytix understands the complexities that must be addressed in Anti-Drug Antibodies analysis, Neutralizing Antibody (NAb) assay development and validation, isotyping, and more. Our experts will help you determine the optimal method for immunogenicity assessment, and select the optimal analytical equipment platform to yield high-quality data results.
Immunogenicity is a significant concern for biologic drugs as it can affect both safety and efficacy. The consequences of product immunogenicity vary from no evidence of clinical effect to severe, life-threatening responses. Therefore the assessment of undesirable immunogenicity of therapeutic proteins and peptides is a key element in biological drug development. In the context of immune-mediated adverse effects of biological drugs, it is critical to understand the interplay of the adaptive and innate immune responses.
In recent years, there has been growing consensus regarding the data needed to assess product immunogenicity. Understanding the incidence, kinetics and magnitude of Anti-Drug Antibodies, its neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and the related clinical impact, may enhance clinical management of patients treated with biologic drugs.
Dr. Arno Kromminga discusses the emerging technologies that are making analytical and clinical data interpretation of immunogenicity more challenging, and the issues that must be addressed in the comparative immunogenicity analysis of an innovative therapeutic and biosimilar.
Our team’s scientific, medical, and technical expertise supports all aspects to assess this key aspect for the approval of the protein drugs. We understand that the measurement of adverse immune reactions is complex as it depends on many drug- and disease-specific aspects. The selection of appropriate assays and an assay strategy has to be selected specifically for each project. A generic approach for the assessment of immunogenicity is not feasible. Challenges in appropriate assay selection include the evaluation of the presence of anti-drug antibodies prior to the initiation of the treatment (pre-existing antibodies) or cross-reactivity of ADA of different isotypes.
Immunogenicity data are interpreted in the context of PK and PD data, but the clinical manifestations of the patients also must be taken into account. Sometimes the loss or reduction of drug efficacy can be observed after a long period of time, measured by disease activity scores or by MRI or other clinical parameters.
Therefore, ADA should not only be measured during drug development in pre-clinical or clinical studies, but also post-approval as a routine monitoring parameter in specialized clinical laboratories.
The cascade of immunogenicity testing is performed following a tiered approach starting with a screening assay, followed by a confirmatory assay and characterization assay.
The assessment of immunogenicity can leverage a variety of analytical equipment platforms. Each of these platforms possesses unique strengths, weaknesses and therefore, optimal uses. BioAgilytix has experience immunogenicity assay development across the bioanalytical lifecycle requiring high drug tolerance levels. We can recommend strategies and provide contract services for assessing immunogenicity using a variety of technologies. The platforms we typically leverage are listed below.
Immunogenicity and bioanalytical assessments are becoming more challenging as the immune system is exposed to more complex biologics. Learn more about this evolving topic in a recent article from one of our experts.
Our experts understand the complexities that must be addressed in immunogenicity testing, including isotyping, ADA analysis, NAb assays, and more, and will help you determine the optimal analytical equipment platform to yield high-quality data results. Specifically, our immunogenicity services include labeling of antibody reagents, ADA purification, and oversight of surrogate positive control antibody generation. Our scientists are experienced in supporting immunogenicity studies in a variety of species including rodents, humans, and non-human primates.