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Bioanalysis Zone Powered by Bioanalysis TOP ARTICLE SUPPLEMENT CONTENTS REVIEW: Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis Bioanalysis Vol. 6 Issue 1 RESEARCH ARTICLE: An ultrasensitive method for the quantitation of active and inactive GLP-1 in human plasma via immunoaffinity LC-MS/MS Bioanalysis Vol. 6 Issue 1 REVIEW: Analytical protocols based on LC–MS, GC–MS and CE–MS for nontargeted metabolomics of biological tissues Bioanalysis Vol. 6 Issue 12 REVIEW Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data ana lysis With the advent of novel technologies, considerable advances have been made in the evaluation of the relationship between PK and PD. Ligand-binding assays have been the primary assay format supporting PK and immunogenicity assessments. Critical and in-depth characterizations of the ligand-binding assay of interest can provide valuable understanding of the limitations, for interpreting PK/PD and immunogenicity results. This review illustrates key challenges with regard to understanding the relationship between anti-drug antibody and PK/PD, including confounding factors associated with the development and validation of ligand-binding assays, mechanisms by which anti-drug antibody impacts PK/PD, factors to consider during data analyses and interpretation, and a perspective on integrating immunogenicity data into the well-established quantitative modeling approach. Through recognizing these challenges, we propose some opportunities for improvements in the development and validation of fit-for- purpose bioanalytical methods. Even though substantial advances have been The immunogenicity to biotherapeutics mea- Yow-Ming C Wang1, Vibha made in the understanding of PK, PD and sured as anti-drug antibody (ADA) response Jawa2 & Mark Ma*3 immunogenicity of biotherapeutics in the past can impact the exposure (PK), response (PD) 1Office of Clinical Pharmacology, decade, there are still several gaps that need to and drug safety (toxicity findings and adverse Office of Translational Sciences, Center for Drug Evaluation & be addressed, especially in the context of new events). Furthermore, immunogenicity has Research, US FDA, MD 20993, USA generation of novel constructs like bispecific been shown to be associated with a reduction 2Department of Clinical Immunology, Amgen, Inc., CA 91320, USA modalities, antibody–drug conjugated (ADC) or loss in efficacy; therefore it is a factor to 3Department of Pharmacokinetics & to small molecules or toxins and recombinant consider in the clinical setting. LBA formats Drug metabolism, Amgen, Inc., One fusion proteins. The increasing complexity and are usually employed to determine the level of Amgen Centre Drive, Thousand Oaks, CA 91320, USA novelty in the structure of biotherapeutics calls biotherapeutics immunogenicity quantitatively *Author for correspondence: for a modification or redesign of the existing or qualitatively. However, the reliable assess- E-mail: [email protected] ligand-binding assay (LBA) formats. The evo- ment of PK/PD and ADA can be influenced by lution of biotherapeutics from partially human, the sensitivity, specificity, accuracy and preci- chimeric, humanized and finally to fully human sion of the bioanalytical assays, including the was intended to engineer molecules with closer potential interferences by drug and/or immune resemblance to self-proteins that are more toler- reactive material present in the study samples. ant to immune responses. However, new aspects An increased understanding of the impact of of impurities from cell lines or cell systems, such ADA on PK and PD will enable an adequate as Escherichia coli and yeast were also introduced dose selection for long-term toxicology studies, with the innovative engineering. The desire for as well as first-in-human dosing. The prospective less-frequent dosing and high potency also led awareness of the doses where immune response to the generation of high-concentration for- can pose an obstacle, can be useful in selection mulations, where the biotherapeutics could of low or high doses that can reduce or overcome potentially conglomerate and form dimers, tri- the unwanted response, respectively. mers or aggregates during long-term storage or This review illustrates several key challenges during reconstitution from lyophilized forms. with regard to understanding the ADA and All of these aspects exacerbate the immuno- PK/PD relationships, including the factors to genicity risk and, potentially, leading to reduced consider during PK/PD data interpretation, the efficacy/exposure of biotherapeutics. possible mechanisms by which ADA impact the 10.4155/BIO.13.302 Bioanalysis (2014) 6(1), 79–87 ISSN 1757-6180 79 REVIEW | Wang, Jawa & Ma Key Terms PK/PD, confounding factors associated with the findings in preclinical studies. Immunogenicity Immunogenicity: Ability of development and validation of LBAs and con- is monitored in most preclinical and clinical an antigen, can be the siderations for quantitative model-based ana- studies via the measurement of ADA [7]. It is biotherapeutic, to elicit immune lysis of immuno genicity impact. The review also well-recognized that immunogenicity of bio- responses, which can be highlights the opportunity for improvements therapeutics can vary across products and across humoral and/or cell-mediated immune responses. in order to develop and validate fit-for-purpose study populations, depending on many influenc- bioanalytical methods, while recognizing these ing factors, such as the product origin (e.g., for- Biotherapeutics: Therapeutic material produced challenges. eign or endogenous), the route of administration using biological means, including [8], concomitant medications [9], patient-related recombinant DNA technology. PK/PD evaluations & data factors such as genetic makeup, diseased state Most biotherapeutics are interpretation of the individual and immune-suppressed ver- proteins that are engineered in the laboratory for PK characteristics of biotherapeutics are often sus immune-reactive state of the individuals. pharmaceutical use. complex, involving linear and nonlinear processes. The outcome of immunogenicity can also vary, Ligand-binding assay: The nonlinear PK commonly involves target- ranging from little to no impact to serious health Bioanalytical method for mediated dispositions [1,2]. PD character istics of implications [10,11]. In instances where the impact support of macromolecules in biotherapeutics are also often complex involving of immunogenicity was not clearly delineated preclinical and clinical multiple functional attributes of the molecular during clinical development, postmarketing development, which relies on specific protein binding to the structure, such as Fab region of monoclonal anti- studies may be conducted to provide further analyte of interest. body (mAb) for target engagement, FcgR bind- immunogenicity information following chronic Anti-drug antibody: ing site for antibody-dependent cell cytotoxicity dosing. Antibody that specifically (ADCC ) and complement-dependent cytotoxic- The humoral immune response to proteins targets biotherapeutics ity (CDC), receptor internalization, and so on. is characterized by the generation of antibodies While PK data combined with relevant PD data that could be T-cell-dependent or -independent. allow for the elucidation of exposure–response The T-cell-independent antibody responses may (E–R) relationships of desired effects; PK data be generated when B-cells recognize a repeated combined with safety/toxicity data provides infor- pattern (motif) in the therapeutics and respond mation on E–R relationships of undesired effects. by transiently producing low-affinity, pre- In order to obtain E–R relationships that are use- dominately IgM antibodies [12]. On the other ful and impactful for decision-making in develop- hand, high-affinity antibodies generated in ment programs, two elements are essential. The conjunction with T-cell help are referred to first is the selection of clinically meaningful PD as T-cell-dependent or thymus-dependent markers, because the resulting E–R relationships antibodies. will have enhanced probability of being correlated The T-cell-dependent antibody response is with clinical outcomes [3,4]. The second is the an outcome of interplay of antigen presenting selection of the most relevant bioanalytical assay cells, T-cells, secreted cytokines and B-cells. The that can produce concentration data reflective of mature immune response to the exogenously the moiety(ies) associated with PD responses [5]. administered biotherapeutics is also influenced E–R relationships are often the foundation by the genetic factors associated with each indi- for decision-making at milestones of develop- vidual, such as HLA haplotype expression and ment programs. For instance, preclinical E–R T-cell/B-cell repertoire. The T-cell-independent facilitates the decision of advancing into clini- low affinity responses are primarily observed cal development and of the first-in-human dose within a couple weeks after the first dose of the selection; E–R data from Phase II dose-ranging biotherapeutics. Subsequently, chronic mul- studies facilitate the selection of dose(s) for con- tiple dosing with the biotherapeutics can be firmatory Phase III studies; the demonstration of associated with the T-cell-dependent antibody E–R in pivotal Phase III studies can serve as
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