Chromatography has evolved from its origins in the 19th century to become a fundamental component of drug development, particularly as the industry shifts towards complex molecules and advanced modalities. This evolution underscores the necessity for robust purification strategies that not only meet regulatory standards but also ensure patient safety and maximize therapeutic potential.
As drug developers increasingly focus on complex modalities like Antibody Drug Conjugates (ADCs) and Highly Potent Active Pharmaceutical Ingredients (HPAPIs), the challenges of scaling chromatography from laboratory to commercial production become apparent. Factors such as resin availability, pressure drops, and equipment limitations can hinder the translation of bench-scale methods to large-scale operations, leading to costly delays. Contract Development and Manufacturing Organizations (CDMOs) play a pivotal role in addressing these challenges through deep process understanding and strategic technology transfers, enabling efficient purification that aligns with the demands of modern drug development.
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