Mastering QbD for Successful Process Validation Campaigns and Commercial Manufacturing of Biologics

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Webinar Date/Time: Thu, Apr 25, 2024 11:00 AM EDT

Learn more about Quality by Design principles and how they can be applied in drug product development to bring better biologics to patients faster.

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Event Overview:

Quality by Design (QbD) has transformed the approach to biologics manufacturing and quality assurance by shifting the focus from end-product testing to process understanding and design control. The implementation of QbD enables biopharmaceutical companies to expedite development timelines, reduce costs, and ensure product safety, efficacy, and overall quality. In this webinar, bioprocess experts involved in biologics production will discuss the challenges associated with the implementation of QbD in the development and manufacturing of biologics. The webinar will include a case study illustrating how QbD principles can be applied in drug product development to overcome challenges, achieve desirable outcomes, and bring better biologics to patients faster.

Key Learning Objectives:

  • Understand the evolution of the QbD paradigm in the industry
  • Discuss the practical aspects of QbD, including risk assessment, process mapping, and design of experiments
  • Demonstrate how to apply QbD principles throughout each stage of development with practical examples

Who Should Attend:

  • Heads of Mfg
  • Heads of Ops
  • Heads of R&D
  • Heads of CMC
  • Heads of Analytical Development
  • Heads of Product Development
  • Heads of Formulation Development
  • Consultants


Claudia Berdugo-Davis, PhD
Director, Process Development
Catalent Biologics

Dr Berdugo-Davis strives to implement biomanufacturing processes that are both scalable and optimized to complement overall unit operations. She currently leads process development at Catalent Biologics. Before joining Catalent, Dr Berdugo-Davis was a scientist at Becton, Dickinson and Company (now BD), where she worked on development of media and media supplements for the pharmaceutical industry and studied the application of bioreactor scale down systems for process development applications. Her previous positions include an internship at GlaxoSmithKline, where she performed studies to evaluate mass transfer capabilities and improve bioreactor performance, and as a process engineer in the petrochemical industry. In this role, she applied her chemical engineering background for biotechnological applications. As part of her post-doctoral work, Dr Berdugo-Davis provided training on the use of a shear stress device to companies including Biogen, Genentech, Amgen, and Millipore. She received her doctorate in Chemical Engineering from The Ohio State University, Columbus in 2010.

Anurag S. Rathore, PhD
Professor, Department of Chemical Engineering
Indian Institute of Technology, Delhi

Dr Anurag S. Rathore is an Institute Chair Professor for the Department of Chemical Engineering at the Indian Institute of Technology, Delhi, India. He is also the coordinator for the DBT COE for Biopharmaceutical Technology. His previous roles included management positions at Amgen Inc., Thousand Oaks, California, and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, medical image analysis, process analytical technology, and quality by design. Dr Rathore has authored more than 600 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of The AAPS Journal and Associate Editor for Journal of Chemical Technology and Biotechnology. He also serves on the editorial advisory boards for Biotechnology Progress, Biotechnology Journal, Electrophoresis, BioPharm International, Journal of Chromatography B, Journal of Chromatography Open, Pharmaceutical Technology Europe, and Separation and Purification Reviews. Dr Rathore has edited books titled Process Validation (2023), Preparative Chromatography for Separation of Proteins and Peptides (2017), Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004), and Scale-up and Optimization in Preparative Chromatography (2003). He has a PhD in Chemical Engineering, which he obtained from Yale University.

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