PQLI®: Case Studies in QbD for Biotechnology and Small Molecule Product Realization (E02)

7-8 June CEUs: 1.2

Sponsored by PQLI.

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 compliment 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 realization) 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. Additionally, the regulatory implications of what has been proposed can be discussed.

How You Will Benefit

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

• Understand the application of both simple and advanced Quality by Design principles with emphasis on biotechnology products, including small molecule applications
• 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

Who Should Attend

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

Leaders

• Ranjit Deshmukh, PhD, Senior Director of Corporate Technical Science, MedImmune, USA
• Beth Junker, Senior Scientific Director, Biologics Pre-Clinical Development Group, Merck & Co Inc, USA

Speakers

• Eric Ahuja, PhD, Director: Analytical Chemistry, Development and Supply, Merck & Co Inc, USA
• Barry Cherney, Supervisor Biologist, FDA, USA
• Kumar Dhanasekharan, Principal Scientist-Engineer, Genzyme Corporation, USA
• Tara Gooen, LCDR, PHS, Team Leader, FDA/CDER/DMPQ, USA
• John Groskoph, Director, New Products Group, Pfizer, USA
• Irwin Hirsh, Principle Specialist (Quality), Novo Nordisk, Sweden
• Duncan Low, PhD, Scientific Executive Director, Amgen Inc, USA
• Michael Schousboe, Senior QbD Manager, Novo Nordisk A/S, Denmark
• Deborah Shnek, Director Process Development, , USA
• Stephen Tyler, Director, Quality Engineering, Abbott Laboratories, USA
• Victor Vinci, PhD, Director, Bioprocess Operations, Eli Lilly & Co, USA
• Keith Webber, Deputy Director, DHHS/FDA/CDER/OPS, USA
• William Whitford, Bioprocessing Marketing Manager, Thermo Fisher Scientific, USA
• Wendy Zwolenski-Lambert, Director, Pharma Business Support, Abbott Laboratories, USA

Communities of Practice (COPs)

• Biotech
• PAT
• Product Process Development
• API
• OSD
• Sterile Products Processing

Knowledge Elements

• 1 - Product Development
  • A. Formulation, clinical phases, and manufacture
  • B. Technology transfer
  • C. Production scale-up and optimization
• 5 - Production systems
  • A. Production unit operations - drug (small molecule) and biologics
  • C. Production Control
• 6 - Regulatory compliance (includes drugs, environmental, health and safety)
  • A. Government regulations
  • B. Standards, practices, and guides
• 7 - Quality systems
  • A. Risk management and Quality Management System (QMS)
  • B. Systems validation (changed from Validated Controls)

Related Information

• PQLI Web site at www.ISPE.org/PQLI
• A-Mab Case Study ( 5 MB) accessible on the PQLI Web site

PQLI Program Committee

• Timothy J.N. Watson, PhD, Assoc. Res. Fellow, Pfizer, USA
• William Whitford, Bioproc. Market Manager, ThermoFisher Scientific, USA
• Duncan Low, PhD, Sci. Exec. Dir., Amgen, USA
• Victor A. Vinci, PhD, Director, Eli Lilly & Co., USA
• Irwin Hersh, Expert, Novo Nordisk, DENMARK
• Wendy Z. Lambert, MSc, Assoc. Res. Fellow, Pfizer, USA
• Kumar Dhanasekharan, PhD, Tech Dev, Genzyme, USA
• John Donabauer, PhD, Abbott, USA

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.