Making the Financial Pitch for Continuous Manufacturing: Thinking Like a CFO
The science and engineering behind continuous manufacturing (CM) has demonstrated the advantages this advanced technology has over tried and true batch manufacturing for pharmaceutical drug production. Nevertheless, adoption of CM has proceeded more slowly despite FDA support and reported benefits from various pilots and use cases. Part of what holds back further expansion of CM […]
Boosting manufacturing efficiency and reliability with AI
Moving from buzzword to bold implementations, artificial intelligence (AI) could have applications across the pharma manufacturing value chain to improve areas such as yield analytics and stock level maintenance. This session will look at where, and how, AI can boost to boost pharma manufacturing’s efficiency and reliability, including:
Digital transformation and pharma manufacturing
From digital twins and artificial intelligence (AI) to the Internet of Things (IoT), individual technologies are being steadily integrated into pharma manufacturing processes, but wholesale digital transformations remain elusive. This session will cover the big picture of digital and manufacturing, presenting strategic approaches to digitalisation, including:
Navigating regulatory change in the US and Europe
Amid unpreceded regulatory disruption, and landmark legislative change, biopharma manufacturers are being subjected to an onslaught of new directions with which to contend. This session will focus on some of the key challenges facing biopharma manufacturers as they strive to remain responsive to regulatory changes, including:
Quality control, and reference standards, in the GLP-1 era
The evolution of GLP-1 drugs from successful diabetes treatments to industry-shaping obesity products has brought with it critical quality control and regulatory compliance challenges. This session will discuss how pharma manufacturers can ensure test methods’ analytical accuracy when identifying and controlling impurities, including:
Lightening the nitrosamine load
Regulatory requirements for nitrosamine impurities are evolving, and the long-running issue continues to present pharma manufacturers with significant risk assessment, confirmatory testing and control strategy implications. As companies contend with the management of nitrosamine drug substance-related impurity (NDSRI) formation across a growing number of products, this session will cover:
Optimising contamination control
Minimising the risk of microbial contamination requires careful planning, operation, equipment and process decisions as part of an overarching contamination control strategy. This session will discuss some state-of-the-art approaches to establishing and innovating contamination control, including:
What It Takes to Move Beyond LAL:
A real-world perspective What does it really take to move beyond traditional LAL testing? In this session, Dr. Harmen Hawer shares a real-world perspective on transitioning to more sustainable endotoxin testing approaches. The presentation provides scientific background on classical endotoxin testing methods in comparison with modern alternatives, while also highlighting practical laboratory workflows, challenges encountered […]
Modernising environmental monitoring
Waves of pharmaceutical product innovation require environmental monitoring approaches that can advance in lockstep with the increasing range of emerging modalities and advanced therapies. Amid this progress, traditional environmental monitoring practices remain the standard for detection of environmental signals. Despite a focus on rapid microbiological methods, the uptake and acceptance of alternative methods has been […]
