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Freeze Drying of In Vitro Diagnostics - 15-16 May - JJ Thomson Avenue, Cambridge, CB3 0US

Biopharma Group is hosting the 3rd edition of the popular freeze drying seminar series at the University of Cambridge. This year, the focus is on "Freeze Drying of In Vitro Diagnostics".

This 2-day seminar will cover a set of lectures and practical assignments covering:

· An evaluation of in vitro regulations in relation to diagnostics
· The fundamentals of PCR chemistry
· Planning R&D, production and scale-up in compliance with IVDR guidelines
· Handling of diagnostic products

On site, the team will be demonstrating our line of analytical instruments including the new LyobeadPro®, Lyostat 5 & MicroPress, and a benchtop freeze dryer Advantage Pro from ATS Scientific Products will also be available to discuss with our product specialists.

*Book your place today*

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Where: University of Cambridge, JJ Thomson Avenue, Cambridge, CB3 0US
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When: May 15, 2024 10:30 am - 17:00 pm May 16, 2024 9:00 am - 03:00 pm
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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

Attendance Price: £450 (per person) 
Book here

Presenters:

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Transport Options
As a sustainable building, we do not have any designated parking available. For those who do need to drive please be advised to use the park and ride which is located off Madingley road.

Madingley rd, Park and Ride
Lansdowne rd, Cambridge CB3 0EU

Guests are welcome to cycle, take a taxi or catch the U bus which stops directly outside the West Hub at the West Cambridge West Hub stop.

Accessible parking spaces are located along JJ Thomson Avenue. Guests can enter the West Hub via the main sliding door entrance, opposite the Ray Dolby Centre.

www.westcambridgehub.uk

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Suggestions of Accommodation

Hyatt Centric Hotel
www.hyatt.com

Turing Locke
www.lockeliving.com

Attendance Price: £450 (per person) 
Book here