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

Head-Toxicology, Safety Assessment

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

Consultant (Uro-Oncology Franchise)

Ferring Pharmaceutical Inc, USA

Vasiliki Kalodimou

Director at Flow Cytometry – Research & Regenerative Medicine Department

Iaso

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

Day 1 – Session 3

Presentation

9:45 – 10:15 BST

Innovation vs. Adaptation:

Key learning points for this session:

Changes in frequency in environmental monitoring and their difficulties in adaptation according to c-annex 1.
New requirements in media fills according to current Annex 1 and the real benefit behind the increased costs.
Recent technology advancement in environmental monitoring and the challenge in their adaptation

Doris Lacej

Head of infusion solutions department

Profarma sha

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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

Vice President of R&D

United States Pharmacopoeia

Moderator

Dr. Archana Bahuguna

Regulatory Compliance Specialist

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

Deputy General Manager (Analytical)

Innoxel Lifesciences Pvt Ltd

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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

Malcolm Rossi

Analytical Specialist – External and Member of Nitrosamine Task Force

Novartis

Sharmin Afroz

Sr. Asst. Manager, PD-ARD

Radiant Pharmaceuticals Ltd.

Ziyaur Rahman

Professor of Pharmaceutical Sciences

Texas A&M University

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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

Senior lecturer in analytical chemistry

Liverpool John Moores University

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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

Rajasekhar Reddy Poonuru

Professor

St. Peter’s Institute Of Pharmaceutical Sciences

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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

Rajasekhar Reddy Poonuru

Professor

St. Peter’s Institute Of Pharmaceutical Sciences

Timothy Francis

Technical Specialist, LAL Division

Fujifilm Wako Chemicals USA

Moderator

Tim Sandle

Head of QA GxP Compliance

Kedrion Biopharma, Inc.

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

Head of Process Analytical Technology, Data Engineering and Data Science

ReciBioPharm

Moderator

Ian Betteridge

Director of Content

European Pharmaceutical Review

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The Future of

Bio/Pharmaceutical Analysis

Agenda

Application of Artificial Intelligence to Predict Toxicity

AI-Driven Biomanufacturing:

Revolutionising Production and Quality in Pharmaceuticals

Moderator

Innovation vs. Adaptation:

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

Moderator

Navigating the Global Landscape:

Challenges and Opportunities in Analytical and Quality Standards

Moderator

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

Moderator

Sponsored by

Successful Mitigation Strategies for Nitrosamines

Moderator

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

Moderator

An Overview of Various Endotoxin Detection Tests

Moderator

Sponsored by

Innovative Technologies for Rapid and Sensitive Endotoxin Detection

Moderator

Empowering 5.0 Biosolutions through Realtime PAT and Computational Controls

Moderator