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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 1 – Session 1
Presentation
8:00 – 8:20 BST

Application of Artificial Intelligence to Predict Toxicity

  • The use of in silico models to predict toxicity and its advantages over traditional in vitro and in vivo approaches
  • Understanding the limitations of in silico techniques – how to avoid applying them blindly in every instance
Varun Ahuja

Varun Ahuja

Head-Toxicology, Safety Assessment Speakers
Syngene International Limited
Day 1 – Session 2
Panel
8:30 – 9:30 BST

AI-Driven Biomanufacturing:

Revolutionising Production and Quality in Pharmaceuticals

  • How can pharmaceutical manufacturers leverage AI technology for quality control applications?
  • Embracing digital innovation across pharmaceutical manufacturing and testing – from artificial intelligence/machine learning and AR/VR to robotic process automation
  • How to use AI to customise QA/QC strategies, enhancing efficiency and minimising waste, while maintaining top-tier standards
  • Real-life examples of AI-enabled applications in biomanufacturing
Daniel Thadani

Daniel Thadani

Consultant (Uro-Oncology Franchise)
Ferring Pharmaceutical Inc, USA
Vasiliki Kalodimou

Vasiliki Kalodimou

Director at Flow Cytometry – Research & Regenerative Medicine Department
Iaso
Day 1 – Session 3
Presentation
9:45 – 10:15 BST

Innovation vs. Adaptation:

Annex 1, Balancing the Need of Technological Advancement With the Challenges Related To Their Adaptation

Day 1 – Session 4
Panel
10:30 – 11:30 BST

Navigating the Global Landscape:

Challenges and Opportunities in Analytical and Quality Standards

  • Global regulatory environment – present and future concerns
  • Supporting product safety and compliance in an increasingly complex regulatory environment
  • How do you keep up with the accelerating pace of digitalisation in manufacturing
  • Improving data traceability and security – from risk assessments to access controls
  • Discussing other challenges and opportunities in analytical and quality standards

Mrunal Jaywant

Mrunal Jaywant

United States Pharmacopoeia
Archana Bahuguna

Archana Bahuguna

Founding Expert Member and Nitrosamine Exchange Ambassador
Regulatory Compliance SME
Day 1 – Session 5
Presentation
11:45 – 12:15 BST

Analytical Method Validation of Nitrosamine Impurity for Drug Substance & Drug Product

  • Small molecule nitrosamine impurity & NDSRIs
  • Importance of risk assessment report and specification criteria
  • Requirement of validation
  • Validation parameters and case study
Jigar Shah

Jigar Shah

Deputy General Manager (Analytical)
Innoxel Lifesciences Pvt Ltd
Day 1 – Session 6
Panel
12:30 – 13:30 BST

Successful Mitigation Strategies for Nitrosamines

  • Nitrosamine contamination in the context of increased regulatory assessments for marketed products and new drug applications
  • Nitrosamine remediation: which way to go – low nitrite excipients or addition of scavengers?
  • Debating the recent challenges related to N-nitrosodimethylamine (NDMA) contamination and N-Nitrosamine drug substance-related impurities (NDSRIs). Nitrites in excipients leading to nitrosamine formation in drug product
  • An update on the latest guidelines on nitrosamine risk evaluation and risk assessment. On the path to international regulatory harmonisation

Malcom Rossi

Malcolm Rossi

Analytical Specialist – External and Member of Nitrosamine Task Force
Novartis
Ziyaur Rahman

Ziyaur Rahman

Professor of Pharmaceutical Sciences
Texas A&M University
Day 1 – Session 7
Presentation
13:45 – 14:15 BST

Evaluation of Four Spectroscopic Techniques for Rapid Authentication of Covid-19 Vaccines

  • ATR-FTIR, NIR, Raman and fluorescence spectroscopy are complementary in authenticating Covid-19 vaccines
  • Selecting the appropriate spectroscopic technique depends on the products’ physicochemical properties and requirements to maintain product integrity
  • Spatially offset Raman spectroscopy for maintaining products integrity
  • Where product can be destroyed, synchronous fluorescence, ATR-FTIR, or NIR can be used provided interference from water is addressed for ATR-FTIR and NIR spectroscopy
Sulaf Assi

Sulaf Assi

Senior lecturer in analytical chemistry
Liverpool John Moores University
Day 1 – Session 8
Presentation
14:30 – 14:45 BST

An Overview of Various Endotoxin Detection Tests

  • Debating which techniques are most effective at detecting endotoxins swiftly and sensitively to prevent severe illness
  • Field-effect transistor (FET) biosensors and aptamers as one of the most promising biosensors in recent years
  • Endotoxin detection advancement including techniques such as molecular imprinting, quartz crystal microbalance (QCM), HPLC, and electrochemical approaches
  • Discussing a new technique involving recombinant cascade reagent (rCR), which replicates the LAL reaction naturally without utilising horseshoe-derived blood cells
  • Other promising methods for endotoxin detection that allow for quick, label-free and sensitive analysis – using the mass sensing capabilities of quartz crystal microbalance (QCM) and the highly specific binding sites created by molecular imprinting (MIP)
  • Focus on an in vitro test called the Monocyte Activation Test (MAT) that gauges how human monocytes react to endotoxins making it an alternative where traditional methods cannot suffice
  • The rolling droplets technique as one additional novel technique that detects amphiphiles at extremely low concentrations by using rolling droplets on micro structured surfaces
Sponsored by
Fujifilm Wako logo
Day 1 – Session 9
Panel
15:00 – 16:00 BST

Innovative Technologies for Rapid and Sensitive Endotoxin Detection

  • The rise of recombinant methods for bacterial endotoxin testing
  • The latest guidelines and regional variations on recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR)
  • Different approaches and strategies for method validation
Tim Sandle

Tim Sandle

Head of QA GxP Compliance
Kedrion Biopharma, Inc.
Timothy Francis

Timothy Francis

Technical Specialist, LAL Division
Fujifilm Wako Chemicals USA
Day 1 – Session 10
Presentation
16:15 – 16:45 BST

Empowering 5.0 Biosolutions through Realtime PAT and Computational Controls

  • Real-time testing utilising PAT. How continuous manufacturing can help reduce costs, increase productivity, and improve product consistency
  • How the integration of process analytical technologies (PAT) and AI-driven computation techniques is a key enabler of continuous mRNA manufacturing
  • Data-driven decision-making process using ML/AL
  • Digital twins and digital infrastructure
  • Seamless manufacturing using PAT and Digital Twins
Edita Botonjic-Sehic

Edita Botonjic-Sehic

Head of Process Analytical Technology, Data Engineering and Data Science
ReciBioPharm
Day 1 – Session 11
Talk
17:00 – 18:00 BST

Innovation vs. Regulation:

Balancing the Pace of  Analytical Technological Advancement with Evolving Regulatory Frameworks

Valentin Poirier

Valentin Poirier

Solutions Product Manager
Bruker BioSpin GmbH & Co. KG
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