Optimized Manufacturing of mAb-based Products: Flexibility, Speed, and Efficiency can Co-exist

Optimized Manufacturing of mAb-based Products: Flexibility, Speed, and Efficiency can Co-exist

04/17/2018, 2:30 PM - 3:15 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall


The manufacture of mAb-based products represents a large portion of many company's drug substance pipeline. In order to ensure that critical business goals focused on manufacturing optimization and lower cost-of-goods can be supported by new manufacturing assets, developing operational-driven approaches to process and facility design is the main driver of many current and future-looking projects. A facility asset that supports rapid deployment and delivery, flexibility for both multi-product and multi-phase manufacturing, and high manufacturing utilization is the benchmark for success today. This presentation will develop the Manufacturing Enterprise model and define the impact of CQAs and CPPs on facility design that allows for flexible mAb production. Discussions on fed-batch and continuous manufacturing approaches, single-use and hybrid platforms, integrated engineering focused on control strategy, open architecture solutions, and rapid deployment models will address the question of design optimization. What are the attributes that define flexibility and how can they be met? Case study examples will be presented to support these options and the facility delivery model.


  • Jeff Odum


    Global Technology Partner


Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives 1. Understand the impact of unit operational analysis in optimized facility design 2. Identification of the critical relationship between CQAs and CPPs in facility design 3. Create an integrated execution approach for optimized facility design to support multi-phase manufacturing approaches


  1. Track
    Optimizing Facilities through Innovation & Technologies

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