Article | April 8, 2019

CMC Strategies For The Acceleration Of Commercial-Ready ADC Manufacturing

Source: AbbVie

By Courtney Morgret, Senior Scientist – Manufacturing Sciences, AbbVie

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The potential for antibody-drug conjugate (ADC) programs to accelerate from early to late stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently. Reduced time to market is key to deliver urgently-needed therapeutics to patients, as well as to secure commercial success and maximize return on investment.

Commercial launch readiness can be expedited through calculated planning of process/analytical development and characterization, commercial manufacturing site selection, and manufacturing-scale process performance qualification (PPQ).  An effective strategy will reduce the probability of late-stage process, analytical, or manufacturing site changes which could put chemistry, manufacturing and control (CMC) activities on the critical path.

Partnering with an experienced contract development and manufacturing organization (CDMO) can streamline the acceleration of commercial-ready ADC manufacturing. With established platform processes to allow for improved early-phase process understanding, and comprehensive knowledge of the scientific, technical, and regulatory requirements to bring a launch-enabling CMC dossier to health authorities, an ideal CDMO will offer unrivalled expertise to support every aspect of the process.

 

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