Seminar Timetable: 

DAY 1 - Wednesday 15 May 
10:30-11:00 - Registration and Coffee
11:00-12:00 - Session 1: Welcome and Introduction - session leader: Dr Kevin Ward

• Applications and challenges of freeze-drying across the diagnostics sector
• Input variables and output parameters for a freeze-dried product
• The traditional iterative approach to formulation and lyo cycle development

12:00-12:24 - Session 2: PCR Chemistry - Fundamental Aspects - session leader: TBC

• Essential ingredients: Enzymes, Buffers, Primers and Probes
  

12:40-13:30 - Lunch break 
13:30-14:30 - Session 3: Formulation Design for Freeze Dried Diagnostics - session leader: Dr Edmond Ekenlebie

• The effect of formulation ingredients on freeze-drying behaviour and critical temperatures
• Considerations for non-vial formats, including Lyobeads
• Case studies
  

14:30-15:30 - Session 4: Formulation Characterisation for Freeze-Drying - session leader: Dr Bhaskar Pandya

• Establishing fundamental lyo behaviour and critical temperatures
• Freeze-drying microscopy, thermal properties and other frozen-state phenomena
  

15:30-16:00 - Refreshment break 
16:00-16:45 - Session 5: IVDR - In Vitro Diagnostics Regulations - session leader: TBC

• Fundamental aspects of IVDR and how it differs from previous IVD guidance and practice
  

16:45-17:00 - Day 1 Final Q&A and Wrap-Up

DAY 2 - Thursday 16 May 
09:00-09:45 - Session 6: Practical Application of IVDR for Diagnostics Products - session leader: Niloofar Ganji

• Considerations for planning, R&D and production, in light of IVDR
  

09:45-10:30 - Session 7: Post-Lyo Handling and Secondary Packaging Challenges - session leader: Mervyn Middleton

• Handling hygroscopic materials, sealing of primary packaging, moisture uptake

10:30-11:00 - Refreshment break 
11:00-11:45 - Session 8: Scale-Up for Lyophilised Diagnostic Products - session leader: Dr Bhaskar Pandya

• Allowing for Scale-Up: Theoretical and Practical Considerations

11:45-12:45 - Practical Sessions and Demonstrations: Part 1

• Group A: Tour of Cambridge Centre for Medical Materials Facility / Open Lab
  by Dr Dan Bax, Research Fellow
  University of Cambridge
• Group B: Handling Lyocakes and Lyobeads - assessing appearance and mechanical properties
  - Generating Lyobeads - the LyobeadPRO
  - Measuring mechanical properties - the MicroPress

12:45-13:30 - Lunch break
13:30-14:30 - Practical Sessions and Demonstrations: Part 2

• Group A: Handling Lyocakes and Lyobeads - assessing appearance and mechanical properties
  - Generating Lyobeads - the LyobeadPRO
  - Measuring mechanical properties - the MicroPress
• Group B: Tour of Cambridge Centre for Medical Materials Facility / Open Lab
  by Dr Dan Bax, Research Fellow
  University of Cambridge

14:30-14:45 - Final Q&A, Wrap-Up and Take-Home Messages

Suggestions of Accommodation

Hyatt Centric Hotel
www.hyatt.com

Turing Locke
www.lockeliving.com