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*

Where:

University of Cambridge, JJ Thomson Avenue, Cambridge, CB3 0US

West Hub building, first floor, room EAST 2

Visit for directrions

When:

May 15, 2024, 10:30 am

May 16, 2024, 9:00 am

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Attendance Price: £450 (per person)

Seminar Timetable:

DAY 1 - Wednesday 15th May

Registration and Coffee

10:30 - 11:00

Session 1: Welcome and Introduction

• 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

11:00 - 12:00

Session Leader:

Dr Kevin Ward

Session 2: PCR Chemistry - Fundamental Aspects

• Essential ingredients: Enzymes, Buffers, Primers and Probes

12:00 - 12:45

Session Leader:

To be confirmed

Lunch Break

12:45 - 13:30

Session 3: Formulation Design for Freeze Dried Diagnostics

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

13:30 - 14:30

Session Leader:

Dr Edmond Ekenlebie

Session 4: Formulation Characterisation for Freeze-Drying

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

14:30 - 15:30

Session Leader:

Dr Bhaskar Pandya

Refreshment Break

15:30 - 16:00

Session 5: IVDR - In Vitro Diagnostics Regulations

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

16:00 - 16:45

Session Leader:

To be confirmed

Day 1 Final Q&A and Wrap-Up

16:45 - 17:00

DAY 2 - Thursday 16th May

Session 6: Practical Application of IVDR for Diagnostics Products

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

9:00 - 9:45

Session Leader:

Niloofar Ganji

Session 7: Post-Lyo Handling and Secondary Packaging Challenges

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

9:45 - 10:30

Session Leader:

Mervyn Middleton

Refreshment Break

10:30 - 11:00

Session 8: Scale-Up for Lyophilised Diagnostic Products

• Allowing for Scale-Up: Theoretical and Practical Considerations

11:00 - 11:45

Session Leader:

Dr Bhaskar Pandya

Practical Sessions and Demonstrations: Part 1

11:45 - 12:45

Group A

Group B

Tour of Cambridge Centre for Medical Materials Facility / Open Lab

by Dr Dan Bax, Research Fellow

University of Cambridge

Handling Lyocakes and Lyobeads - assessing appearance and mechanical properties

• Generating Lyobeads - the LyobeadPRO®
• Measuring mechanical properties - the MicroPress

Lunch Break

12:45 - 13:30

Practical Sessions and Demonstrations: Part 2

13:30 - 14:30

Group A

Group B

Handling Lyocakes and Lyobeads - assessing appearance and mechanical properties

• Generating Lyobeads - the LyobeadPRO®
• Measuring mechanical properties - the MicroPress

Tour of Cambridge Centre for Medical Materials Facility / Open Lab

by Dr Dan Bax, Research Fellow

University of Cambridge

Final Q&A, Wrap-Up and Take-Home Messages

14:30 - 14:45

Attendance Price: £450 (per person)

Our Presenters

Dr Kevin Ward

DIRECTOR OF R&D

Dr Edmond Ekenlebie

R&D MANAGER

Dr Bhaskar Pandya

SENIOR SCIENTIST

Mervyn Middleton

SENIOR SCIENTIST

Niloofar Ganji

RESEARCH SCIENTIST

Dr Johannes Kehle

GLOBAL MOLECULAR DIAGNOSTICS, QUIDEL

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

Suggestions of Accommodation

Hyatt Centric Hotel

www.hyatt.com

Turing Locke

www.lockeliving.com

Attendance Price: £450 (per person)

www.biopharmagroupcdmo.com