The emergence of artificial intelligence and machine learning has been transforming all sectors. How can pharmaceutical manufacturers leverage this technology for quality control applications?
Through illustrative examples of Industry 4.0 technologies including artificial intelligence/machine learning, robotic process automation, AR/VR, this presentation showcases the tangible business benefits, both financial and operational, derived from embracing digital innovation across pharmaceutical manufacturing and testing.
Join to discover:
Digital Transformation Leader
Dr Reddy’s Laboratories
The pharmaceutical industry is on the verge of a revolution driven by artificial intelligence (AI). In the next five years, AI is expected to permeate every aspect of drug development, from identifying promising targets to designing effective therapies, ensuring patient safety, and optimising manufacturing.
In this presentation, you will discover:
Director Analytics
LabVantage Solutions
Head of Technical Sales Support
LabVantage Solutions
Almost six years after N-nitrosodimethylamine (NDMA) contamination was first identified, the toxic short alkyl chain N-nitrosamine issue appears on the way to resolution. In contrast, N-Nitrosamine drug substance-related impurities (NDSRIs) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. This session will:
Head-Toxicology, Safety Assessment
Syngene International Ltd
Senior Applications Chemist
Ellutia
Senior Manager, Nitrosamine Testing and Analytical Technologies
TEVA Pharmaceuticals
Director of R&D
Cambrex
Analytical Specialist - External and Member of Nitrosamine Task Force
Novartis
Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador
12.00 – 12.30 pm CET
Break
Discover the latest recommendations for chemistry and manufacturing controls required to identify the potency, purity and safety of advanced therapeutic medicinal products (ATMPs). This session will cover:
Head of Process Development
ReiThera
Senior Director of CMC, for a major Advanced Therapy Developer and manufacturer in Europe
VP European Manufacturing and Technical Operations
Adaptimmune
QP and GMP Compliance Consultant
eXmoor
Principal
Advanced Cell & Gene Therapy, LLC
With an ever-increasing focus on sustainability across the pharmaceutical industry, many companies are looking to recombinant methods for bacterial endotoxin testing. During this panel discussion, experts will discuss the latest guidelines and regional variations on recombinant Factor C (rFC) and recombinant Cascade Reagents (rCR). Make sure you join to:
SME Testing Services
Lonza
Chief Microbiologist, Global Quality
AstraZeneca
Deputy Head Microbiology Safety Section
Paul-Ehrlich-Institut
Senior Principal Scientist
Merck Research Laboratories
Head of QA GxP Compliance and Sterility Assurance
Bio Products Laboratory
Traditional batch production methods in biopharmaceuticals manufacturing require human intervention to process materials and can take months to complete the final formulated product, resulting in high costs and prolonged delivery of therapeutics to patients. Factors that influence the cost include the complexity of the mRNA sequence/structure, yield and purity of the manufacturing process, batch size, facility overheads, and regulatory compliance.
Join this session to learn:
Head of Process Analytics and Data Science
ReciBioPharm
In antibody-drug conjugates (ADCs), the drug load, that is how many drugs are attached to an antibody, and the drug’s sites of attachment, are important quality characteristics that can be assessed by mass spectrometry.
Join this session to learn for two separate presentations that cover:
Senior Principal Scientist, Protein Characterisation Team
Lonza Biologics
Principal Scientist
Dragonfly Therapeutics
After almost two decades, ICH Q2(R1) guideline on validation of analytical procedures have been revised to integrate knowledge management principles while broadening its applicability to encompass a diverse array of technologies and address multivariate procedures helping support the validation of Real Time Release testing (RTRT). ICH Q2(R2) became official in November of 2023 and this session will:
Scientific Affairs Manager
USP and scientific liaison for the USP Analytical Procedure Lifecycle Joint Subcommittee (JS)
6.15 pm CET
Agenda Close
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