Executive Development Programme in Biopharmaceutical Antibody Analysis
-- ViewingNowThe Executive Development Programme in Biopharmaceutical Antibody Analysis is a comprehensive certificate course, designed to meet the growing industry demand for expertise in antibody analysis. This program emphasizes the importance of understanding the biopharmaceutical landscape, regulatory requirements, and cutting-edge analytical techniques for antibody characterization.
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โข Introduction to Biopharmaceutical Antibody Analysis: Overview of antibodies, their structure, and function; Importance of antibody analysis in biopharmaceuticals; Regulatory guidelines.
โข Analytical Techniques for Antibody Analysis: Characterization methods (size-exclusion chromatography, field-flow fractionation, mass spectrometry); Potency assays (competitive/non-competitive, sandwich/binding, surface plasmon resonance, bio-layer interferometry).
โข Immunogenicity Testing: Principles of immunogenicity, clinical impact, and regulatory requirements; In vitro and in vivo methods for immunogenicity assessment; Risk mitigation strategies.
โข Biophysical Characterization of Antibodies: Techniques for biophysical characterization (circular dichroism, differential scanning calorimetry, dynamic light scattering, intrinsic fluorescence, static light scattering); Impact on stability, aggregation, and functionality.
โข Biotherapeutic Antibody Development: Antibody engineering and design; Selection of appropriate antibody format; Choice of animal models and expression systems; Upstream and downstream processing.
โข Quality Control and Quality Assurance: Quality management systems, regulatory compliance, and best practices; Process validation, method validation, and data integrity; Change management and continuous improvement.
โข Clinical Development and Translation: Biomarker discovery and validation; Phase I-IV clinical trial design and execution; Pharmacokinetics, pharmacodynamics, and toxicity; Biomanufacturing scale-up considerations.
โข Commercialization and Market Access: Intellectual property protection; Market analysis and competitive landscape; Pricing, reimbursement, and market access strategies.
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