PQLI®: Case Studies in QbD for Biotechnology and Small Molecule Product Realisation

Monday 20 September - Tuesday 21 September

Seminar Content Level: Intermediate - Advanced

Seminar Leader: Ranjit R. Deshmukh, Pfizer, USA

Is Quality by Design (QbD) applicable to biotechnology? Yes, and by participating in this two-day Product Quality Lifecycle Implementation® (PQLI®) workshop you will understand and discuss the A-Mab case study, which is the latest thinking in the application of QbD to biotechnology.

This workshop provides the ideal forum to understand and take away practical examples of how principles of QbD can be applied to biotechnology, product development, and manufacturing. To complement the biotech approach and for comparison, a second case study developed by a PQLI team (a core component of a forthcoming ISPE Good Practice Guide on Product Realisation) will be presented that explains QbD principles for a small molecule drug substance and drug product.

Through these case studies and discussion you will better understand tools and processes to identify critical quality attributes and process parameters, as well as how an integrated control strategy can be developed and implemented in manufacturing. Additionally, the regulatory implications of what has been proposed can be discussed. PQLI’s early thoughts will be discussed on implementation of a modern pharmaceutical quality system, for example a company change management process.

Take Back to Your Job:

At the conclusion of this session, participants will be able to:

  • Understand the application of both simple and advanced Quality by Design principles and their application, for example in manufacturing
  • Apply tools and processes to identify critical quality attributes and process parameters
  • Explain how integrated control strategies can be developed
  • Discuss regulatory implications of application of QbD
  • Input to PQLI’s programme to implement a modern pharmaceutical quality system

Related Technical Documents, Articles, and Publications

A-Mab Case Study accessible on the PQLI Web site, www.ISPE.org/PQLI

Who Should Attend

Development, manufacturing, operations, technical services, quality assurance, quality control, process engineers, regulatory affairs, senior management, and life sciences professionals

Communities of Practice (COPs):

Sponsoring COPs: Biotech, PAT, and Product Process Development

Related COPs: API, OSD, and Sterile Products Processing



Day 1, Monday 20 September

10.00 – 10.10 Welcome and Introduction
Ranjit R Deshmukh, MedImmune (USA) and Beth Junker, Merck (USA)

10.10 – 10.50 PQLI Roadmap: Product Design, Development and Realisation; a Science and Risk-based Approach to Implementation on Product Realisation
Steve Tyler, Abbott (USA)

  • Introduction to the new guide
  • PQLI progress and new initiatives
  • Small molecule illustrative example and further development work on AMAb large molecule case study

10.50 – 11.30 Update on FDA Pilot Programme on QbD Applications in Biotechnology
Patrick Swann, USFDA (USA)

  • Current status of the pilot programme
  • Consensus element sponsors are implementing well
  • Opportunities for more dialogue and more industry data

11.30 – 12.10 EU Regulatory Feedback on QbD Applications in Biotechnology
Mats Welin, Medical Product Agency (Sweden)

  • Handling QbD related issues for biotechnology products within in EU
  • Regulatory perspective on QbD related submissions in biotechnology products
  • Key emergent issues in these submissions
  • What are the implementation areas EMA regulators would like to see developed more

12.10 – 12.30 Introduction to Workshops
Ranjit R. Deshmukh, MedImmune (USA) and Beth Junker, Merck (USA)

12.30 – 13.30 Lunch and Networking Break

13.30 – 15.15 Workshop 1: Case Studies and Discussions in Successfully Implementing ICH Q10 and Topics in PQS
Rob Hughes, Astra Zeneca (USA)

  • Key issues and solutions in implementing Q10

15.15 – 15.45 Break

15.45 – 17.30 Workshop 2: A-Mab Case Study and Further Developments in Applying QbD for Biologicals
Michael Defelippis, Lilly (USA), John Berridge, ISPE (UK)

  • Key learnings from the case study
  • Updates on implementing QbD
  • What are the next steps?

17.30 Close of Day 1
Ranjit R Deshmukh, MedImmune (USA) and Beth Junker, Merck (USA)

17.45 – 18.45 Exhibition Networking Reception

Day 2, Tuesday 21 September

09.00 – 09.15 Review of Day 1, Introduction to Day 2
Ranjit R Deshmukh, MedImmune (USA) and Beth Junker, Merck (USA)

09.15 – 10.30 Workshop 3 - Discussions on Using First Principle Models, Multivariate Analysis to Build, Describe Design Space and Manage Control Strategies
John Lepore, Merck & Co Inc (USA); Bruce Davis, Global Consulting (UK)

  • Examples on use of models
  • How do you maintain models?
  • Implementation challenges for small molecules and biologics

10.30 – 11.00 Break

11.00 – 12.30 Workshop 4 - How Much QbD for Raw Materials and Excepients: Small Molecules and Biologics Issue
William Whitford, Thermo Fisher Scientific (USA); John Donabauer, Abbott (USA) (TBC)

  • What is the starting material?
  • What data is sufficient?
  • What are the QbD strategies being implemented to complement current practices?
  • What do you need to add to Q11?

12.30 – 13.30 Lunch and Networking Break

13.30 – 14.15 Biological QbD: Genentech Perspective
Nirdosh Jagota, Genentech (USA)

  • Approaches for QbD for biologicals
  • Strategies for implementation

14.15 – 15.00 Assembling the Business case for Biopharmaceutical QbD Implementation
Beth Junker, Merck (USA)

  • Establishing qualitative and quantitative benefits
  • Weighing costs and benefits
  • Estimating return-on-investment (ROI)

15.00 – 16.00 Panel Discussion, Questions and Answers, Next Steps, Close of Seminar
Ranjit R. Deshmukh, MedImmune (USA) and Beth Junker, Merck (USA)