Quality by Design: A New Paradigm for the Development and Commercialization of Biopharmaceuticals: One and a Half Day In-Person Seminar

By: Drew N. Kelner, Ph.D, President, Colorado Biotechnology Consultants, LLC
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Course Description:

The paradigm for biopharmaceutical development and commercialization has been dramatically impacted by the advent of Quality by Design approaches that have been driven by the regulatory authorities and encapsulated in recent FDA, EMEA, and ICH guidelines. The traditional approach, in which the process provides for the characteristics of the product (a paradigm in which “the process is the product”), is being replaced by development programs that pre-define the desirable product quality attributes and then develop the process to reproducibly meet those requirements. This approach, used in many industries to build the quality into the product, relies heavily on understanding how the characteristics of the product are impacted by the manufacturing process, as well as on the use of risk assessment methodologies to focus the process and product control strategies on the attributes of the product that impact its quality. This strategy is replacing the traditional approach, in which a large battery of analytical tests- “all of the usual suspects”- are tracked by in-process and/or release (specification) tests without regard to whether or not variations in product attributes impact the safety or efficacy of the product. The structural and functional complexity of biological drugs will be presented, along with the analytical approaches that are used to track quality attributes of biopharmaceuticals. The application of Quality by Design principles to the development of monoclonal antibodies (the major class of licensed biopharmaceuticals) will be emphasized. The use of powerful modern analytical tools to determine the physiological relevance of protein quality attributes will be presented to demonstrate how product knowledge informs the process control strategy and product specifications. The importance of protein immunogenicity, and the ways in immunogenicity risks can be mitigated, will also be discussed. The advantages of Quality-by-Design approaches in process, formulation, and analytical development, and how the Quality by Design approach enables product commercialization, will be presented, along with case studies to illustrate key concepts of the Quality-by-Design approach. In 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.

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
  • 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.

Who will Benefit:

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, quality control, quality assurance, manufacturing staff, and executive leadership. Another potential target audience is attorneys who specialize in biotechnology law, particularly those who engage in litigation of biopharmaceutical patent disputes, as this will provide a valuable overview of the key issues in biotechnology process development and commercialization.

Course Outline:

Day One (8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration, Meet & Greet.
  • 9:00 AM -10:00 AM: Lecture 1: Introduction
    • Seminar objectives preview, expectations and scope
    • From Gene to Protein: The Business of Biopharmaceuticals
    • Biopharmaceuticals Past, Present and Future
  • 10:00 AM - 11:00 AM: Lecture 2: The special challenges of developing protein-based drugs
    • Protein micro-heterogeneity: post-synthetic modifications
    • Protein stability and major degradation mechanisms
    • Product Quality Attributes in biopharmaceuticals: process and analytical challenges
  • 11:00 AM - 12:00 Noon: Lecture 3: Considerations on Protein Safety
    • Immunogenicity of protein-based drugs
    • Modern approaches to assessing clinical safety
  • 12:00 Noon - 1:00 PM: Lunch (Overview of Quality Design Principles: A New Paradigm for Biopharmaceutical Development)
  • 1:00 PM - 2:00 PM:
    • Regulatory Expectations for registration of protein-based drugs- the traditional approach
    • Regulatory expectations for the Quality by Design approach
  • 2:00 PM - 3:00 PM: Lecture 4: Quality by Design in Practice
    • Designing the molecule
    • Design Space and the Quality by Design Control Strategy
    • Risk Assessment Concepts
  • 3:00 PM - 4:15 PM: Lecture 5: Analytical Considerations
    • Capabilities of modern protein characterization methods
    • Method Design in a Quality by Design World
    • Biopharmaceutical Specifications Past, Present and Future
  • 4:15 PM - 4:30 PM: Day 1 review and wrap up
Day Two (9:00 AM - 1:00 PM)
  • 9:00 AM -10:00 AM: Lecture 6: Monoclonal Antibodies: A Leading Driver of Biopharmaceutical Growth
    • Antibody structure/function
    • Antibody quality attributes: What Matters
    • Considerations on antibody constructs of the future
  • 10:00 AM - 11:00 AM: Lecture 7: Protein Glycosylation: Safety and Efficacy Considerations
    • Overview of protein glycosylation (antibody emphasis)
    • Effector functions and antibody clearance mechanisms
    • The conventional approach vs. the Quality by Design approach to glycosylation specifications and controls
  • 11:00 AM - 12:30 PM: Lecture 6: Quality Attributes and application of Quality by Design Principles in the Real World
    • Advantages of the Quality by Design approach in creating the control strategy
    • Case studies in quality issues and how the Quality by Design development approach mitigates risks to safety and efficacy
  • 12:30 PM – 1:00 PM: Review and Wrap Up

Meet Your Instructor

Drew N. Kelner
Drew N. Kelner, Ph.D
President, Colorado Biotechnology Consultants, LLC

JA 30 year biotechnology industry veteran with extensive leadership experience in analytical, formulation and drug product development, Drew Nathaniel Kelner retired in May 2015 from his position as Executive Director of Global Analytical Sciences at Amgen, where he was responsible for the company’s worldwide analytical organization, including management of the organizational interfaces between Analytical Development, Quality Control and Regulatory Affairs.

Dr. Kelner has extensive leadership and change management experience, including 10 years at Bayer Biotechnology and 12 years at Amgen. In his last position at Amgen as the Executive Director of Global Analytical Sciences, he successfully built a global analytical development organization to more efficiently serve the needs of the world’s largest independent biotechnology company at a time of significant growth in the late-stage pipeline, including the development and commercialization of multiple biosimilars referencing industry-leading biopharmaceuticals such as Humira, Avastin, Herceptin, and Remicade.

During his career, he has served as a scientific advisor and/or section author for regulatory guidance documents in the United States, European Union, and Japan, including guidance covering monoclonal antibody production and quality control, analytical method validation, the application of Quality by Design to biotechnology product development, product comparability and biosimilarity. Dr. Kelner is currently the President of Colorado Biotechnology Consultants, in which he leverages his experience in the trenches of the biotechnology industry to provide biotechnology companies with proven and effective scientific and business strategies for solving their most perplexing scientific, regulatory, and organizational challenges.

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