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EPR - the future of bio/pharmaceutical analysis online summit 2025 logo

The Future of

Bio/Pharmaceutical Analysis

Agenda

Day 1  |  Day 2

Day 1

18th June

Day 2

19th June

Day 2 – Session 1
Talk
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
Karen Kapper

Karen Capper

Head of Microbiology, New Modalities and Parenteral Development
AstraZeneca
Day 2 – Session 2
Presentation
09:00 – 10:00 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

Dan Bach Christensen

Dan Bach Christensen

Scientific Director
Symphogen
Day 2 – Session 3
Presentation
10:30 – 11:30 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

Clifford Rossi

Professor-of-the-Practice, Executive-in-Residence, SERC Director
University of Maryland
Ian Betteridge
Moderator

Ian Betteridge

Director of Content
European Pharmaceutical Review
Sponsored by
Lonza logo
Day 2 – Session 4
Presentation
12:00 – 13:00 BST

PRESENTATION: Endotoxin Control Strategies for New Products

This presentation explores the Low Endotoxin Recovery (LER) phenomenon, the underlying chemistry and the history behind its interpretation.

Attendees will learn:

  • How LER impacts endotoxin testing accuracy
  • Strategies for potential remediation
  • Ongoing efforts to revise PDA TR-82 to align with emerging analytical advancements
Allen Burgenson

Allen Burgenson

SME Testing Services
Lonza Walkersville, Inc.
Tim Sandle
Moderator

Tim Sandle

Head of QA GxP Compliance
Kedrion Biopharma, Inc.
Sponsored by
Bruker logo
Day 2 – Session 5
Panel
13:30 – 14:30 BST

Innovation vs. Regulation:

Balancing the Pace of Analytical Technological Advancement with Evolving Regulatory Frameworks

The pharmaceutical industry has experienced considerable transformation over the past decade, characterized by a notable shift towards biologics and a revived focus on peptide and oligonucleotide drug modalities. It has also witnessed significant changes in the regulatory landscape, particularly with the recent implementation of Analytical Quality by Design concepts. The full ramifications and impacts of these developments on pharmaceutical quality control are yet to be completely ascertained. In this panel discussion, we will explore how this evolving environment, alongside pressing sustainability concerns, drives and fosters innovation in advanced pharmaceutical analytics. We will deliberate on strategies and analytical solutions designed to address the future of quality control, encompassing both the principles of quality and sustainability.

Ben Shapiro

Ben Shapiro

Director – Digital Product Development and Marketing
U.S. Pharmacopeia
Charles Heise

Charles Heise

Associate Director (BPSD, Process Development)
FUJIFILM Diosynth Biotechnologies
James Heindl

James Heindl

Principal Scientist at Thermo Fisher Scientific
Patheon
Valentin Poirier
Moderator

Valentin Poirier

Solutions Product Manager
Bruker
Sponsored by
Charles River and ACC logos
Day 2 – Session 6
Panel
14:45 – 15:45 BST

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
Amala Saju

Amala Saju

Regulatory Affairs Strategist
Sanofi
Miriam Guest

Miriam Guest

Senior Principal Scientific Advisor, Microbial Solutions
Charles River
Veronika Wills

Veronika Wills

Director of Global Technical Services
Associates of Cape Cod, Inc.
Ian Betteridge
Moderator

Ian Betteridge

Director of Content
European Pharmaceutical Review
Day 2 – Session 7
Case Study
16:00 – 16.30 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

Emiliano Dominicis

Chemistry Research Director
Merieux NutriSciences
Ian Betteridge
Moderator

Ian Betteridge

Director of Content
European Pharmaceutical Review

Day 1

18th June

Day 2

19th June

Register Now

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