Accelerating automation and moving towards ‘lights-out’ factories
Manufacturing sites offer increasing important opportunities for streamlining and optimising process, productivity and quality. This session will look at how robotic technologies can be harnessed for the safe and effective scaling of manufacturing, including:
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:
Transforming endotoxin testing
Endotoxin testing is a crucial element of pharma companies’ contamination control strategies, with significant patient safety, product quality and manufacturing process implications. Amid growing pressure on pharma manufacturers to take a more sustainable approach to their endotoxin tests and drastically reduce their reliance on finite natural resources, this session will discuss:
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 and processes are also in need of updating, with novel tools and technologies an often untapped resource. This session will discuss:
Amala Saju
Amala Saju is a regulatory affairs professional experienced in Chemistry, Manufacturing, and Controls (CMC) across global pharmaceutical companies, including Pfizer, Novo Nordisk, and currently, Sanofi. Her expertise lies in CMC technical writing focused on pharmaceutical manufacturing processes, quality control, and product specifications to support global regulatory submissions and compliance. She has contributed to over 100 […]
