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Who should attend Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals
The course material is highly relevant for a broad spectrum of biopharmaceutical industry staff, including research scientists, process development scientists (process, analytical, formulation and drug product), regulatory affairs.
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Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals  

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The course material is highly relevant for a broad spectrum of biopharmaceutical industry staff, including research scientists, process development scientists (process, analytical, formulation and drug product), regulatory affairs.

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Seminar Summary:

This seminar will provide the attendee with an understanding of how the Quality by Design approach has altered the way in which modern biopharmaceuticals are developed, manufactured, and licensed by the regulatory authorities. (see full course description)

 
 

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Training Course Syllabus:


Course Description:

This seminar will help you to understand impact of Quality by Design Principles on the development and commercialization of biopharmaceuticals.

Learning Objectives:

Attendees will gain an understanding of the:

  • Structural and functional complexity of biopharmaceuticals, including the impact of post-synthetic modifications and major degradation pathways on safety and efficacy

  • Regulatory requirements for the licensing of biopharmaceuticals

  • Sources and potential consequences of protein immunogenicity

  • The principles of the Quality by Design approach to biopharmaceutical development

  • Means for determining the physiological relevance of protein quality attributes and the relevant Critical Quality Attributes of biopharmaceutical products

  • The importance of protein glycosylation and means for determining the potential relevance of variations in glycosylation profiles

  • The importance of designing the right molecule for the desired clinical effect

  • The concept of process design space and its relationship to the process and product control strategy

  • Risk assessment approaches to process and product development

  • Capabilities of modern protein characterization methods, and how they enable the Quality by Design approach

  • Capabilities of modern protein characterization methods, and how they enable the Quality by Design approach

  • Quality by Design approaches to method development and validation

  • The link between process parameters, product attributes and a rational specification strategy
  • Areas Covered:

  • Protein structure/function, with an emphasis on monoclonal antibodies, the most abundant class of licensed biopharmaceuticals

  • Harmonized international regulatory expectations for licensing biopharmaceuticals in the 21st Century

  • Product quality attributes of proteins and their impact on safety and efficacy, including the sources of protein immunogenicity

  • Application of Quality by Design principles to the development of biopharmaceutical processes and analytical methods

  • Quality-by-Design based specifications and control strategy

  • DAY 01(8:30 AM - 4:30 PM)

  • 8:30 AM - 8:59 AM: Registration, Meet & Greet.
  • Lecture 1: Introduction
  • Lecture 2: The special challenges of developing protein-based drugs
  • Lecture 3: Considerations on Protein Safety
  • Lunch (Overview of Quality Design Principles: A New Paradigm for Biopharmaceutical Development)
  • Lecture 4: Quality by Design in Practice
  • Lecture 5: Analytical Considerations
  • Day 1 review and wrap up


  • DAY 02(9:00 AM - 1:00 PM)

  • Lecture 6: Monoclonal Antibodies: A Leading Driver of Biopharmaceutical Growth
  • Lecture 7: Protein Glycosylation: Safety and Efficacy Considerations
  • Lecture 6: Quality Attributes and application of Quality by Design Principles in the Real World
  • Review and Wrap Up
  • Seminar Summary:

    This seminar will provide the attendee with an understanding of how the Quality by Design approach has altered the way in which modern biopharmaceuticals are developed, manufactured, and licensed by the regulatory authorities. (see full course description)

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