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Abstract

<jats:p>The analytical target profile (ATP) is a cornerstone of modern and enhanced approaches to analytical development in the biopharmaceutical industry. It provides a structured, risk-based framework for method development, validation, and lifecycle management. As regulatory expectations evolve and products become more complex, the need for harmonized, practical guidance on ATP implementation has never been greater. This guide highlights benchmarking data from 27 biopharmaceutical companies with diverse portfolios and various business models, offering a comprehensive overview of current practices, challenges and actionable recommendations. Through detailed analysis and real-world case studies, it aims to support organizations in achieving robust, compliant and efficient analytical strategies throughout the analytical procedure lifecycle.</jats:p>

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Keywords

analytical development biopharmaceutical lifecycle target

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