PAT & QbD brochure (PDF) - JMP
PAT & QbD brochure (PDF) - JMP
PAT & QbD brochure (PDF) - JMP
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Conference Day Two: 20th January 2010<br />
08.45 Chairperson’s Opening Remarks<br />
08.55 KEYNOTE PRESENTATION<br />
Case Study: Development of a Monoclonal<br />
Antibody Using <strong>QbD</strong>: Results from the Industry<br />
Consortium<br />
• Overview of the case study describing<br />
monoclonal antibody development from molecule<br />
design through validation<br />
• Examples of risk assessment strategy and tools used<br />
• Examples of the use of prior platform knowledge<br />
and experimental design for mammalian cell<br />
culture and protein purification<br />
• The analysis leading toward critical quality<br />
attributes (CQAs) and control strategy<br />
• A proposal for design space and lifecycle<br />
management of the process and product<br />
Dr Victor A. Vinci, Director, Bioprocess<br />
Operations, Eli Lilly and Company<br />
09.40 Using <strong>QbD</strong> Approaches to Enable Development<br />
of Real-Time-Release for a Continuous Drug<br />
Product Process<br />
• Discussion of the <strong>QbD</strong> risk management<br />
approaches used at Pfizer<br />
• Generation of process understanding and design<br />
space capable of supporting a <strong>QbD</strong> filing<br />
• Moving from batch processing to continuous<br />
processing for Pharmaceutical drug products<br />
• Implementation of CQV and RTR in<br />
pharmaceutical manufacturing at Pfizer<br />
David Sharp, Senior Principal Scientist, Pfizer<br />
10.20 Business Case on the use of <strong>PAT</strong> in an Oral<br />
Solid Dosage Pilot Plant<br />
• Outlining a successful <strong>PAT</strong> implementation in an<br />
Oral Solid Dosage Pilot Plant<br />
• Overcoming some of the key challenges in<br />
putting a <strong>PAT</strong> strategy into practice<br />
• Discussion of how <strong>PAT</strong> has contributed towards<br />
cost saving objectives by helping speed up the<br />
development process and shorten the production<br />
time<br />
Patrick Bossuyt, SI<strong>PAT</strong> Sales Executive, SIEMENS<br />
11.00 Networking Coffee Break<br />
11.30 Case Study: Developing a Successful Change<br />
Management Approach When Implementing<br />
<strong>QbD</strong> in a Global Company<br />
• How do you approach implementing new<br />
concepts like <strong>QbD</strong> within the wider business<br />
• Overcoming the challenge of change by<br />
illustrating the benefits and securing buy in.<br />
• Ensuring the business keeps running with both<br />
current and new paradigm’s during implementation<br />
• Preparing for when <strong>QbD</strong> is part of how we run<br />
the business<br />
Michael Schousboe, Senior <strong>QbD</strong> Manager,<br />
Manufacturing Science and Quality, Novo Nordisk<br />
12.10 Case Study: Application of <strong>QbD</strong> in Development:<br />
Building the Control Strategy for Drug<br />
Substance Critical Quality Attributes in the<br />
Manufacturing Process of a Drug Substance<br />
The quality by design approach adopted for the<br />
definition of the control strategy for a drug in<br />
development is described. Details are given on:<br />
• The risk assessment done to identify the<br />
potential quality critical process parameters<br />
• The multivariate and univariate process studies<br />
undertaken to assess the potential quality<br />
critical process parameters<br />
• The specification controls on the input materials<br />
All these elements of control combined together,<br />
allowed the definition of a robust control<br />
strategy with the potential to remove the “endproduct<br />
testing” for some drug substance-CQAs.<br />
Zadeo Cimarosti, Manager, Chemical<br />
Development, GlaxoSmithKline Verona, Italy<br />
12.50 Panel Discussion: Integrating <strong>QbD</strong> principles<br />
into your Lifecycle Management Programme<br />
• Discussing the benefits of integrating the two<br />
initiatives<br />
• How can this actually be done? What are the<br />
first few steps?<br />
David Sharp, Senior Principal Scientist, Pfizer<br />
Zadeo Cimarosti, Manager, Chemical<br />
Development, GlaxoSmithKline Verona, Italy<br />
Michael Schousboe, Senior <strong>QbD</strong> Manager,<br />
Manufacturing Science & Quality, Novo Nordisk<br />
Philippe Cappuyns, Pharmaceutical Technology<br />
Director, Janssen Pharmaceutica<br />
13.20 Networking Lunch Break<br />
14.20 Case Study: Developing a Strong Business Case<br />
for <strong>QbD</strong> Implementation Within a Contract<br />
Manufacturing Company<br />
• Outlining the challenges faced by a CMO<br />
• Discussing the benefits of using <strong>QbD</strong> in<br />
customer projects<br />
• Highlighting some of the difficulties faced and<br />
how these were overcome<br />
Hans ter Maat, Senior Process Engineer, DSM Biologics<br />
15.00 Case Study: Model-based <strong>QbD</strong> Development<br />
Integrated in a Product Life Cycle Management<br />
Approach<br />
• The presentation will provide a systematic and<br />
proactive <strong>QbD</strong> development approach enabling to<br />
meet current ICH Q8, Q9 and Q10 guidelines<br />
• The characteristics of a model-based <strong>QbD</strong><br />
development methodology and the resulting<br />
benefits will be highlighted<br />
• The presentation will cover the integration of<br />
<strong>QbD</strong> into a Product Life Cycle Management<br />
approach and its business value<br />
Philippe Cappuyns, Pharmaceutical Technology<br />
Director, Janssen Pharmaceutica<br />
15.40 Networking Coffee Break<br />
16.10 Case Study: Delivering Robust Manufacturing<br />
Processes Using a Structured Critical Process<br />
Parameter workflow<br />
• Exemplification of the GSK API critical process<br />
parameter workflow<br />
• Workflow essentials: Planning, process<br />
understanding, performance, uncertainty, risk<br />
and control<br />
• Making it happen, adding value<br />
Martin Owen, Manager, GlaxoSmithKline<br />
16.50 Case Study: Implementing <strong>PAT</strong> and <strong>QbD</strong> at the<br />
Formulation Stage<br />
• Outline the challenges faced when implementing<br />
these tools earlier in the life cycle<br />
• Discussion of key examples used in transdermal<br />
drugs<br />
• Risk analysis study using these tools<br />
• Comparison of predictive and observed results<br />
Dr Barry Gujral MBA, Associate Director, Quality<br />
Engineering, Noven Pharmaceuticals Inc.<br />
Peter Amanatides, Vice President QA and QC,<br />
Noven Pharmaceuticals Inc.<br />
17.30 Chairperson’s Final Remarks and Close of<br />
Conference<br />
CALL: +44 (0)20 7368 9300 / 0800 652 2363 FAX: +44 (0)20 7368 9301 EMAIL: enquire@iqpc.co.uk