Patient Safety in CDMO Operations: Leveraging Quality and Toxicology Synergies to Accelerate Manufacturing Pipelines

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.