12th WCBP CMC STRATEGY FORUM
Quality by Design (QbD) for Biopharmaceuticals
| Forum Co-Chairs: |
|
John Dougherty, Eli Lilly & Company
Steven Kozlowski, CDER, FDA
Rohin Mhatre, Biogen Idec Inc.
Wassim Nashabeh, Genentech, Inc.
Mark Schenerman, MedImmune |
Download the Brochure PDF
The CMC Strategy Forum, co-organized by the FDA and the biotechnology industry, will focus on the implementation of Quality by Design (QbD) during development and manufacturing of biopharmaceuticals. The forum will consist of four workshops on building QbD in the cell culture, purification and formulation development of therapeutic proteins. Each workshop will cover case studies from leading biotech companies and a discussion forum on the application of design space and process analytical technology (PAT) to achieve QbD for the unit operations. The fourth workshop will be related to development and implementation of Quality and Regulatory Systems to support QbD.
The discussion sessions in the forum will address a wide array of questions related to QbD such as:
- How can a design space, developed at small scale, be confirmed at the production scale?
- How are critical quality attributes defined in the early and late clinical phase of the molecule?
- Which unit operations in upstream and downstream processes are most critical for establishing the design space and PAT?
- How does the design space translate to setting operating ranges for the process?
- How would building QbD in a process via design space and PAT change the current process validation paradigm?
- How can unit operation-based platforms be leveraged in the QbD paradigm?
- How can design space be incorporated into a regulatory filing? What is the mechanism to discuss a QbD filing strategy with the regulatory agencies and how would QbD affect the approval process?
- How can Regulatory Agreements, Comparability Protocols or other aspects of QbD filings simplify product lifecycle management? What changes will be required to Regulatory, Quality, and Compliance systems to realize the benefit?
Who should attend: scientists and managers in process development, manufacturing, quality control and regulatory affairs familiar with the concepts of design space and PAT should attend. Since this forum will focus on development of a strategy for implementing QbD in bioprocess development and manufacturing, participants should be knowledgeable in these areas and willing to actively participate in the discussions.
Session 1: Definition of Critical Quality Attributes
Using a Risk Assessment Process to Select Critical Product Quality Attributes
Mark Schenerman, MedImmune, Gaithersburg, MD USA
Workshop Session One Discussion Questions
- What is the process for using risk assessment as a basis for determining critical product quality attributes?
- How can non-clinical and clinical data be used to support the risk assessment process?
- Can data from other products be used to support the risk assessment process (e.g., platform products)?
- What types of testing schemes are most appropriate for attributes that are considered, “critical”, “key”, and “non-critical?”
- How can these categorizations be used as a rationale for testing in a Comparability Protocol?
- How can the risk assessment and supporting data be used as a justification for specifications?
Session 2: Development of Design Space in Cell Culture
Quality by Design in the Development of Post-Approval Changes
Michael Laird, Genentech, Inc., South San Francisco, CA USA
Quality by Design Strategy for a Clinical Cell Culture Process
Thomas Ryll, Biogen Idec Inc., San Diego, CA USA
Workshop Session Two Discussion Questions
- How is Quality by Design (QbD) incorporated into the early and late phases of process development?
- How much attention should be paid to choice of product sequence, cell line and expression technology in context of QbD?
- How is design space confirmed at the production scale?
Session 3: Development of Design Space for a Purification Process
Viral Clearance Design Space for mAb Purification Process
Qi Chen, Genentech, Inc., South San Francisco, CA USA
Formulation Development via Risk Assessment and Design Space Approach: A Case Study
Kingman Ng, Eli Lilly and Company, Indianapolis, IN USA
Introducing Design Space Considerations into Protein Purification Process Development
Jörg Thömmes, Biogen Idec Inc., San Diego, CA USA
Workshop Session Three Discussion Questions
- How are design space studies conducted for the various unit operations so as to meet the desired product quality attributes?
- How is the cell culture design space linked to the purification design space?
- What are the strategies for evaluating viral clearance during the development of the design space for downstream processing?
- How will the design space be incorporated into the operating ranges of the process?
Session 4: Implications of QbD for Regulatory Filings and Approval
Regulatory Approaches for QbD Submissions
Steven Kozlowski, CDER, FDA, Silver Spring, MD USA
EU Perspectives on QbD
Karin Sewerin, AstraZeneca, Bromma, Sweden
Workshop Session Four Discussion Questions
- What is the mechanism to discuss a QbD filing strategy with the regulatory agencies?
- How does QbD impact the current paradigm for pre-approval inspections? What other changes to compliance systems need to be considered?
- How is the risk evaluation and management built into the development of design space?
