Innovations in OSD Processing

Monday 15 - Tuesday 16 September 2008
Manchester, United Kingdom



Seminar Leaders:
Ulrika Henningsson, AstraZeneca (Sweden)
Trevor Page, GEA Pharma Systems (UK)

  • Learn about new technologies in OSD manufacturing
  • Hear from innovative Quality by Design approaches to product and process design
  • Discover innovation in other processing industries

Quality by Design requires innovative thinking. Industry and Regulatory authorities are now using channels like the new Annex to ICH Q8 Pharmaceutical Development guidance and ISPE's PQLI initiative to paint a picture of an industry which will be significantly different in the future.

This picture will demand new and innovative approaches to product design, product specifications, process design and process control. While some of these changes may be novel in our industry, there is much we can learn from techniques which have been well proven to help other industries achieve world class 6 sigma production capabilities. With speakers from a range of backgrounds, this seminar will provide information about innovations from academia and industry, as well as take a broader view of techniques and technologies which are already currently employed in other industries, and which have the potential to improve pharmaceutical development and manufacturing.

The first day of the seminar will be devoted to the design pillar of Quality by Design, and case studies of Design Space developments will be presented as well as new innovative technologies for OSD manufacturing. The second day will be about the performance pillar of Quality by Design, and case studies on process control and quality assurance in real-time will be presented.

Take Back To Your Job:

  • An understanding of the four pillars of QbD: Product Design, Product Performance, Process Design and Process Performance
  • New and updated information on the technologies available for OSD processing
  • Insights into optimising your existing OSD manufacturing
  • Understanding how emerging trends in OSD manufacturing may impact things like quality management and introduction of new products onto your site.

The 2-day seminar will include sessions on:
  • Nano-chemical Approaches to Controlled and Targeted Drug Delivery
  • Lyopan – A Lyophilisation Technology for producing Fast-melting Tablets
  • Continuous Processing of OSD
  • Scientific Approach to Process Design
  • DEM Modelling
  • Real Time Statistical Process Control
  • QbD and ISPE OSD Baseline® Guide 
Case Studies on the following topics will be included: 
  • Design Space
  • Real-time Release
  • Real Time Performance Management in the process industry

Agenda


Monday, 15 September

10.00 – 10.15 Introduction & Welcome by Seminar Leaders
Ulrika Henningsson – AstraZeneca (Sweden)
Trevor Page - GEA Pharma Systems (UK)

10.15 – 11.00 Development of Design Space – case study
Jim Murray – AstraZeneca (UK)

  • Risk based approach
  • Design Space for formulations and processes
  • Development Challenges

11.00 - 11.45 Nano-chemical Approaches to Particles for Controlled and Targeted Drug Delivery of Biomolecules
Barry Moore – XtalBio (UK)

  • Self-assembly via coprecipitation of core excipient and biomolecule
  • Batch or continuous processing
  • Stabilisation of biomolecule on microcrystal surface
  • Platform for advanced drug-delivery applications

11.45 - 12.30 Design Space - A risk based approach
Kevin R Lief - GlaxoSmithKline (UK)

  • Risk based approach to assurance of quality
  • Accounts for the multivariate nature of the critical quality attributes
  • Uses a Quantitative Model linking critical quality attributes to input attributes and process parameters

12.30 - 14.00 Lunch and Networking Break

14.00 - 14.45 Understanding particle processing: How DEM can help reveal the behaviour of granular and particulate materials in real process systems
Dr Chris Riley - DEM Solutions (UK)

  • What is DEM and how does it differ from CFD in the way it treats particles
  • How DEM has helped design real equipment in the construction industry
  • Examples of the application of DEM to pharmaceutical processes

14.45 - 15.30 Real experience in Converting from Batch to continuous processing
Joel Marriott - GlaxoSmithKline (UK)

  • Batch vs continuous – Factors to consider when making a switch to continous processing, is continuous processing right for the product? Pros and Cons of continuous processing. 
  • Important factors in continuous processing - residence time distribution, flow control, transient vs steady state. 
  • Process understanting - looking at scale up. 
  • Material Control - How do we control materials from a reglatory point of view
  • Considerations for regulated products

15.30 - 16.00 Coffee and Networking Break
 
16.00 - 16.45 Britest – a Scientific Approach to Process Design
Paul Sharratt – Britest (UK)

  • Capturing mechanistic process understanding in a form to support sharing within teams
  • Exploiting understanding to drive experimentation and process design
  • Rational equipment selection and analysis
  • Case studies and operational experience of the tools

16.45 - 17.30 Quality by Design implementation – progress in Europe

17.30 Seminar Close

Networking Reception
 

Tuesday, 16 September

09.00 - 09.15 Review of Day 1, Introduction of Day 2
Ulrika Henningsson – AstraZeneca (Sweden)
Trevor Page - GEA Pharma Systems (UK)

09.15 – 10.00 Real Time Release – case study
Ulrika Henningsson – AstraZeneca (Sweden)

  • Business drivers for RTR
  • PAT tools to monitor and control quality attributes
  • Challenges to implementation

10.00 - 10.30 Coffee and networking break 

10.30 - 11.15 Innovation Process meets Containment (Quality by Design)
Richard Denk - Hecht Technologie (Germany)

  • Highly Hazardous Products require a new process understanding and implementation in an OSD facility
  • Are the current OSD technologies designed for highly hazardous products?
  • Brief update on the renewed OSD ISPE  Baseline Guide

11.15 - 12.00 Real Time Statistical Process Monitoring
Erik Johansson - Umetrics (Sweden)

  • Examples from the pharmaceutical and semiconductor industries
  • Visualisation and reporting in real-time
  • From risk assessment to validated process

12.00 - 13.30 Lunch and networking break

13.30 - 14.15 Real Time Performance Management in the Process Industry
Model Predictive Control – 15 years of Reducing Variability & Improving Quality
Process Understanding – Leveraging Fundamental and Empirical Knowledge 
Tom O'Callaghan – Pavilion Technologies, USA

  • Design Space – ensuring model accuracy with multi-dimensional boundaries
  • Lesson’s Learned and Success Achieved in other Industries
  • A Practical Risk Based Approach to Implementation
  • Unit Operations Applicability

14.15 - 15.00 Real Time Release - case study. Real Time Release – case study. Understanding the relationship between    powder properties and the process
Brian Armsrong - Freeman Tech (UK)

  • How material characteristics affect blending
  • Using PEPT to visualise the process
  • Using NIR to detect end point
  • Using powder test methods to predict the process

15.00 - 15.30 Questions & Answers, Close of Seminar
Ulrika Henningsson – AstraZeneca (Sweden)
Trevor Page - GEA Pharma Systems (UK)

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