08.50 Chairperson’s Opening Remarks

09.00 Case Study: Design Space Development for Large Molecules in Upstream Processing Concept

• How to effectively establish a design space for biopharmaceutical product
• Outlining the tools and techniques you will require
• Effectively using a thorough understanding of CQA’s to establish your design space

Following a target-directed process development approach we ‘design processes delivering the desired quality (QbD)’ by science based development supported by multi-variate data analysis. Recent case-studies will focus on the successes as well as challenges in achieving the desired glycosylation and charge isoforms of monoclonal antibodies by upstream development.

Continuing from the knowledge gained during process development, we systematically characterize the process at small-scale to establish a Design Space predictive for large-scale performance with the goal to gain post-launch flexibility for continuous improvement. Our concept and the challenges of small-scale model qualification, setting a quality target product profile for the cell culture harvest, defining upstream process parameter criticality and the Design Space will be explained with recent case-studies.

Dr Corinna Sonderegger
Technical Development Strategy and Planning Manager, Global Biopharmaceutical Operations
Sandoz Austria

09.45 Case Study: Design Space Development For Large Molecules In Downstream Processing

• Establishing a design space for biopharmaceutical products in downstream processing
• Outlining the tools and techniques you will require
• Discussion of the downstream aspect of the industry consortium MAb case study

Amit Banerjee
Research Fellow, Purification
Pfizer USA

11.00 Case Study: The Application Of Microscale Techniques For The Development Of Design Spaces In Chromatographic Separations

• Evaluating the different types of microscale devices that are available for mimicking chromatographic separations
• How these can be implemented on robotic systems for automated screening and characterisation studies
• Examples of the application of such techniques for identifying optimal operating locations within a design space and their scale-up predictions

Dr Sunil Chhatre
Senior Research Fellow, Biochemical Engineering
University College London

11.45 Panel Discussion: Outlining A Strategy For QbD In Biopharmaceutical Process Development

• Discussion of the challenges faced when implementing QbD?
• How can these be overcome and what are the next few steps likely to be?
• How to effectively select and exploit the correct tool set for the job

Panellists:

12.30 Technology Spotlight

This session will be dedicated to a leading service provider from within the PAT and QbD arena, offering you the opportunity to hear first-hand how the latest technology innovations could help you reach your PAT and QbD application goals.

14.00 Portable Quality By Design

• Using the Design of Experiments method is essential for generating a response surface for a complex unit operation or over several integrated steps. However, the analysis applies only to the system tested within narrow conditions and cannot be applied to other processes
• Demonstrating that engineering equations are well suited for describing performance in simpler unit operations, and can be used to make exact predictions on process performance during scale up and transfer
• Making the engineering analysis “portable” by measuring the appropriate engineering parameter (such as mass transfer coefficient, rather than dissolution time.) It will then be applicable to multiple processes, as well as multiple scales

Dr Scott Rudge
COO, RMC Pharmaceutical Solutions Inc. and SVP, Product Development
Bradmer Pharmaceuticals Inc.

14.45 Harnessing The Knowledge From Real Time Data Processing To Support Your PAT/QbD Initiatives

• How to establish the capabilities you need from those you want
• The importance of data management in a QbD approach

Professor Gary Montague
Professor of Bioprocess Control, Newcastle University
UK

16.00 Small To Large Molecules: Transferring The Lessons Learned

• The principles of QbD apply to small molecules, large molecules, analytical methods, medical devices
• Discussion on Design Space, Control Space, Normal Operating Range, how these can be derived and the challenges that can be faced
• Case study example from small molecule API development shows how the acceptable ranges for process parameters can apparently disappear if statistical approaches are applied without thinking
• Evaluating how the risks with natural ingredients and live processes can be even greater
• Outlining the importance of process understanding, good design of experiments and common sense

George Bandurek
Consultant
GRB Solutions Ltd

16.45 Exploiting New Technology Tools For Achieving Quality By Design (QbD) Via Process Analytical Technology (PAT), Process Intensification, And Greener Processing Techniques

• Establishing continuous processing with micro-reactors
• Assessing the application of Micro-analytical tools
• Using standardiSed sampling approaches
• Effectively harnessing PAT and QbD Process optimiSation

Mel Koch
Executive Director
CPAC

17.30 Chairpersons Closing Remarks And Close Of Conference