The Future of

Bio/Pharmaceutical Analysis

Agenda

Day 1 | Day 2

Day 1

18th June

Day 2

19th June

Day 2 – Session 1

Presentation

8:00 – 8:30 BST

The Smart Lab Revolution:

Digitalisation and Automation for Enhanced QA/QC Efficiency and Reliability

Discussing the benefits of the smart lab revolution and what practical steps are needed to apply the smart quality approach
How companies can effectively digitalise, automate, and integrate their quality controls
Focus on some practical examples such as application of a high-throughput automated colony-counting system powered by AI for environmental monitoring

Anke Hossfeld

Global Product Manager BioMonitoring – Pharma Innovation

Merck Life Science

Karen Capper

Head of Microbiology, New Modalities and Parenteral Development

AstraZeneca

Day 2 – Session 2

Presentation

9:00 – 10:00 BST

Continuous Manufacturing:

Transforming Pharmaceutical Production for Efficiency and Agility

Tariffs on pharmaceutical products imposed by the US – the impact on global supply chains and investment decisions

Clifford Rossi

Professor-of-the-Practice, Executive-in-Residence, SERC Director

University of Maryland

Day 2 – Session 3

Presentation

10:30 – 11:30 BST

Next-Gen Biologics Characterisation:

Pushing Boundaries

Advanced characterisation of antibody-drug conjugates and complex formats using integrated automated sample fractionation, digestion, and MS workflows

Endotoxin Control Strategies for New Products

Tim Sandle

Head of QA GxP Compliance

Kedrion Biopharma, Inc.

Allen Burgenson

SME Testing Services

Lonza Walkersville, Inc.

Proactive Compliance:

Building Adaptive Quality Systems to Navigate Future Regulatory Landscapes

This session covers:

An overview of recent developments in the sector and key lessons learnt. Consideration of how these can inform compliance when building quality systems today
How to adapt quality systems amid a rapidly changing industry to support future regulatory compliance
Practical strategies for ensuring a flexible approach when navigating changes in regulation

Day 2 – Session 6

Talk / Panel

14:30 – 15:00 BST

Sustainable Pharma:

Driving Efficiency, Innovation, and Long-Term Value Creation

Day 2 – Session 7

Case Study

15:30 – 16:00 BST

Nitrites and Nitrosamines in Pharmaceuticals

Understanding their impact and ensuring compliance

Nitrosamines, especially those formed through nitrites, remain a significant concern in pharmaceutical safety. Staying compliant with evolving regulations is crucial.

This session will provide insights on:

Regulatory landscape – overview about recent updates
Analytical challenges – techniques for accurate detection
Role of nitrites – their contribution to nitrosamine formation
Case studies – practical insights and real-world examples

Emiliano Dominicis

Chemistry Research Director

Merieux NutriSciences

Day 2 – Session 8

Talk / Panel

16:30 – 17:00 BST

Harnessing IoT and Data Analytics for Proactive Contamination Control

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The Future of

Bio/Pharmaceutical Analysis

Agenda

Day 1

Day 2

The Smart Lab Revolution:

Digitalisation and Automation for Enhanced QA/QC Efficiency and Reliability

Anke Hossfeld

Karen Capper

Continuous Manufacturing:

Transforming Pharmaceutical Production for Efficiency and Agility

Clifford Rossi

Next-Gen Biologics Characterisation:

Pushing Boundaries

Dan Bach Christensen

Sponsored by

Endotoxin Control Strategies for New Products

Tim Sandle

Allen Burgenson

Sponsored by

Proactive Compliance:

Building Adaptive Quality Systems to Navigate Future Regulatory Landscapes

Sustainable Pharma:

Driving Efficiency, Innovation, and Long-Term Value Creation

Nitrites and Nitrosamines in Pharmaceuticals

Understanding their impact and ensuring compliance

Emiliano Dominicis

Harnessing IoT and Data Analytics for Proactive Contamination Control