Antibody-drug conjugates nonclinical support: from early to late nonclinical bioanalysis using ligand-binding assays.
نویسندگان
چکیده
The objective of antibody-drug conjugate (ADC) bioanalysis at different stages of drug development may vary and so are the associated bioanalytical challenges. While at early drug discovery stage involving candidate selection, optimization and preliminary nonclinical assessments, the goal of ADC bioanalysis is to provide PK, toxicity and efficacy data that assists in the design and selection of potential drug candidates, the late nonclinical and clinical drug development stage typically involves regulated ADC bioanalysis that delivers TK data to define and understand pharmacological and toxicological properties of the lead ADC candidate. Bioanalytical strategies and considerations involved in developing successful ligand binding assays for ADC characterization from early discovery to late nonclinical stages of drug development are presented here.
منابع مشابه
Current status of antibody-drug conjugate bioanalysis
ADC bioanalytical strategies With the US FDA approval of Adcetris® (brentuximab vedotin) in 2011 and Kadcyla® (ado-transtuzumab emtansine) in 2013, antibody-drug conjugate (ADC) has been a hot topic in industry. Because of the complexity of an ADC, combining monoclonal antibody and small molecule toxin, its bioanalysis has seen unprecedented amount of discussion compared to other drug modalitie...
متن کاملCharacterization of Critical Reagents for Ligand Binding Assays
the immunogenicity of biotherapeutic molecules, and determine drug concentrations for pharmacokinetic analyses. The accuracy and performance of LBAs, however, depends on the quality of key reagents, called critical reagents. The Global Bioanalysis Consortium (GBC) and the European Medicines Agency classify critical reagents as analyte specific or binding reagents, specifically antibodies; pepti...
متن کاملStrategies to compare clinical antitherapeutic antibody data when changing assay platforms: a case study.
Zhihua Julia Qiu has over 20 years post PhD experience in academic institutes, pharmaceutical industry and biotechnology startup settings; focused on novel therapeutics discovery and development and diagnostic tools. She is currently a Scientist in the Bioanalytical Sciences department at Genentech; responsible for developing, evaluating and implementing Bioanalytical strategy to support protei...
متن کاملEBF recommendation for stability testing of anti-drug antibodies; lessons learned from anti-vaccine antibody stability studies.
Long- and short-term stability testing of the analyte is one of the key parameters in bioanalytical method validation in support of pharmacokinetics. However, for immunogenicity testing, the scientific rationale for long- and short-term stability testing on quality control samples most often spiked with polyclonal antibody raised in a different species should be questioned. Therefore, the Europ...
متن کاملIncurred sample reproducibility and stability assessment in a cell-based drug concentration assay.
Joleen White is Principal Scientist in Translational Sciences at Biogen Idec. Throughout her career, she has applied her background in biophysical protein chemistry to pharmaceutical development in therapeutic indications with significant unmet medical need. In her current role, she supports method development and regulated bioanalysis of biomarkers, biopharmaceuticals, and immunogenicity in bi...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Bioanalysis
دوره 7 13 شماره
صفحات -
تاریخ انتشار 2015