Navigating Nitrosamines: Strategies, Safety, and Supplier Impact

The investments will be made to increase capacity for biologics including recombinant vaccines for COVID-19 and advanced gene therapies in the UK and the US

Pharmacovigilance is not limited to adverse event reporting. Safety data reporting is the first step for detection and mitigation of new drug- related risks, identification of new opportunities to improve medicine and device safety profiles to ensure consumer safety worldwide, guarantee compliance with global and local regulations and increase the commercial interest of the pharmaceutical products.

Hear about the future of pharma from its current young leaders. Join this session featuring our Future Leader Award nominees as they share their insights on the industry's future and discuss strategies to cultivate the next generation of leaders. Discover how these young visionaries are driving change and shaping a more dynamic and sustainable future for the industry.

Even though it should be considered part of our everyday business, is it standard for multimodal CDMOs to truly operate with a holistic quality mindset, prioritizing the health and safety of both workers and patients? At FUJIFILM Diosynth Biotechnologies, quality and safety are two sides of the same coin, with our customers’ patients sitting at the interface of the two. Manufacturing biologically-derived drug substances require pushing the envelope on innovation while maintaining unprecedented quality delivery and meeting regulatory requirements. This mandates a synergistic relationship among safety, quality, and customer stakeholders, specifically in our new product introduction, risk assessment, and risk mitigation processes. This presentation will highlight the unique infrastructure FUJIFILM Diosynth Biotechnologies has built around safety operations and quality, with a focus on our new product introduction and patient risk assessments. The beginning of every drug substance’s manufacturing journey begins with a carefully crafted toxicology assessment and mitigation plan that is predicated on a strong customer mindset, optimizing operational efficiency and accelerating pragmatic risk management solutions. Whether it is an early phase gene therapy or commercial scale protein therapeutic, we partner with customers at every stage of their manufacturing journey to provide appropriate risk management solutions and protect the customers’ patients we ultimately serve.

The role of nutraceuticals in healthcare is growing in prominence and R&D is fueling innovation across the sector to enhance the safety and therapeutic value of dietary supplements and nutraceuticals. Why tapping into the consumer market can help manage current delivery expectations; How can current formulation technology help develop new and sustainable products; How will AI impact the future of Precision Nutrition

Understanding how excipient quality affects drug performance and stability Exploring the differences between excipient grades and their implications for formulation Strategies for ensuring consistent access to high-quality excipients Selecting the optimal excipient grade for targeted drug delivery.

Highlighting common worker safety challenges and opportunities in HPAPI production What practices are required to ensure that workers are protected from highly potent toxins Why its essential to maintain initiatives in product quality, regulations and continuous improvement to help safeguard patient safety during HPAPI production

Join our session on safeguarding the supply chain, where we'll discuss strategies for identifying and managing disruption triggers, implementing strategic mapping and monitoring to prevent bottlenecks, and staying ahead of future disruptions through proactive forecasting.

GMP principles in pharmaceutical ingredient manufacturing for ensuring consistent quality and safety Overview of auditing processes, including planning, execution, reporting, and follow-up actions, to ensure compliance and drive continuous improvement Comparative analysis of regulatory frameworks across key regions, focusing on differences, similarities, challenges, and strategies for ensuring compliance

Fujifilm has been in the healthcare business since the early days of its 90-year history. Today, we provide CDMO services to help our partners develop innovative medicines in the field of biopharmaceuticals. In the field of lipid-nanoparticles (LNPs), Fujifilm's team of synthetic chemists has developed a proprietary library of ionizable lipids. Ionizable lipids are essential LNP components directly related to safety and efficacy. In this presentation, application data of the lipids will be presented. Liposome is a drug-delivery-technology that encapsulates small molecules in stable lipid nanocapsule particles. Even in the world of the 2020s, small molecules are still a promising modality for anticancer drug development. The design of small molecules for hard druggable targets has inherited significant difficulties in reconciling high affinity to targets with other properties: pharmacokinetics, biodistribution and safety. In this session, the presenter will discuss the potential of liposomes in advanced small molecule development and Fujifilm's capabilities.

Join our panel of experts, where we delve into the new frontier in formulation development and how the pharma ecosystem in the Middle East are looking to shape next-generation development

Join our panel as we delve into the role of Critical Medicines Alliance (CMA) initiative that was set by the European Commission. The CMA serves as a consultative platform that unites relevant stakeholders from EU Member States, with its objective is to pinpoint essential areas and priorities for action, offering solutions to bolster the supply of critical medicines in the EU.

The European Union faces a growing challenge in securing its supply of essential pharmaceuticals. Currently, the majority of its active pharmaceutical ingredients (APIs) and finished medicines are imported from Asia, with China being the largest single supplier. This heavy reliance on external sources has raised concerns about the EU's resilience to supply chain disruptions, price volatility, and potential geopolitical risks. To address these concerns, the EESC have set about the Critical Medicines Act to help strengthen the EU's domestic pharmaceutical production capacity.

Your CDMO Partner Advancing Medicines Through Critical Milestones With Expert CMC Support Services

We are an established leader in advancing vaccines from preclinical development to commercial supply across multiple modalities.

Our gene therapy process development and manufacturing capabilities are designed to confidently and rapidly progress your products from gene to market through development of robust and reproducible cGMP practices.

We are a world-leader in process development and cGMP manufacturing of proteins derived from a range of microbial hosts including E. coli, P. pastoris and S. cerevisiae .

End-to-end services designed for patient safetyand centricitywhile offering contracting convenience, cost efficiencies and time savingsOur globally integrated drug product (DP) and finished goods (FG) services offer agileand flexible solutions for clinical to commercial products. OurDP capabilities include aseptic filling in vials, pre-filled syringes or cartridges using state-of the-art isolator technologies,phase appropriate process development, formulation,stability and release testing of clinical and commercial products. Our FG capabilities include assembly, packaging and labeling lines in addition to storage capacity.

Your CDMO Partner Advancing Cell Therapies to Patients

FUJIFILM Diosynth Biotechnologies is a leading provider of cell culture services for biologics, advancing and delivering life changing therapies. We offer complete solutions for cell line development, process development,late phase activities, clinical and commercial manufacturing of a wide variety of biopharmaceuticals.

"We’re looking for people who share our passion, drive, and energy – what we call Genki – to join our team"