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Critical Path in Biopharma Projects: A CMC Manager’s Perspective

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  In the highly specialized field of biopharmaceutical development, managing the critical path is essential to ensure the successful advancement of products and their timely introduction to market. Delays in this process not only disrupt project schedules but also postpone access to vital therapies for patients. For a CMC (Chemistry, Manufacturing, and Controls) Manager, overseeing the critical path is a key responsibility that directly impacts technical outcomes and regulatory timelines. In this edition of the newsletter, we will explore the concept of the critical path, its importance in biopharma projects, and effective strategies to address potential challenges — all from the perspective of a CMC Manager. What is the Critical Path? At its core, the critical path is the sequence of dependent tasks that determine the shortest time needed to complete a project. If any task on the critical path is delayed, the entire project timeline shifts. The Critical Path Method (CPM) originate...
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Streamlining Biopharma Manufacturing: The Role of Manufacturing Execution System (MES)

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                   Introduction In the fast-evolving world of biopharma, efficient manufacturing processes are critical to delivering high-quality therapies to patients quickly and cost-effectively. As therapies become more personalized and production scales more complex, robust tools are needed to address these challenges. Among the technological advancements driving this transformation is the Manufacturing Execution System (MES)—a powerful digital tool that bridges the gap between production and enterprise systems. In this edition, we explore the basics of MES, its origins, how it is implemented in biopharma manufacturing, its advantages, and the challenges of adoption. We’ll also discuss how MES improves key operational metrics such as turnaround time and capacity utilization, using a real-world case study to highlight its impact. What is Manufacturing Execution System? A Manufacturing Execution System (MES) is a software-based s...
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