From CAR-T therapies and Artificial Intelligence (AI), to the enactment of the Drug Supply Chain Security Act (DSCSA), the past five years alone have been transformative for the industry. Unimaginable innovation in drug development has led to more complex and increasingly targeted therapies for smaller patient populations, particularly in the orphan disease and emerging cell and gene space, resulting in manufacturing challenges that require technically advanced solutions. Complexities related to formulation and delivery, and manufacturing and cold chain management of highly-potent drug products and biologics, have all led to increased outsourcing across the continuum, from drug discovery and development through to manufacturing and packaging. Some of the factors influencing the industry and outsourcing are more drug approvals requiring advanced manufacturing techniques, rigorous quality and regulatory demands requiring extensive data and validation of operations, and continuous manufacturing efforts to modernize drug production and improve operations, as well as overcoming waste and potential drug shortages. Click Here For Complete Article Text
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