The landscape of parental drug manufacturing is rapidly evolving, with the continuous emergence of new and more efficient technologies, as well as the advent of novel therapeutic modalities. Discuss novel, enabling, and diverse strategies to overcome current and emerging challenges in sterile product manufacturing.
Theme 1. Present and Future of Drug-Device Combination for Sterile Products
Keywords: Devices, Combination Products, Compliance, Sustainability, Lifecycle Management, Implantable Devices
Focus on the present and future of drug-device combination across all modalities for sterile products such as autoinjectors, connected and smart autoinjectors, both biodurable and bioerodible implantable devices (i.e., intraocular, subcutaneous, intrathecal, etc.), large-volume patch injectors, etc. Discuss the regulatory and compliance aspects, comparative analyses for generic combination products, industrial challenges, product sustainability, lifecycle management, and other technological advances.
Theme 2. Tackling the CMC Challenges of New Therapeutic Modalities
Keywords: New Therapeutic Modalities, Cell and Gene Therapy, Autologous Therapy, Cold Chain Management, Biologics
The curative potential of new therapeutic modalities (such as cell and gene therapy, nucleotide-based therapeutics, and in vivo expressed biologics) has led to an explosion of interest and investment in this space in the past five years. While parallels can be drawn with small molecule drugs and monoclonal antibodies, there are a number of unique and significant challenges for the manufacture of these novel therapeutics. Discuss topics such as new technologies to increase yields, reduce manufacturing costs, and shorten turnaround time, as well as chain of identity and chain of custody for autologous therapies, cold chain management, agile supply chains supporting a resilient ecosystem, accessibility of GMP-grade reagents, and regulatory/compliance expectations.
Theme 3. Current Trends in Parenteral Drug Manufacturing
Keywords: Process Development, Manufacturing Facility, Environmental Monitoring, Process Engineering, Novel Excipients, Lipid Nanoparticles, Supply Chain
Parenteral administration has enabled targeted drug delivery of complex molecules such as proteins and mRNA, as well as small molecules for treating various diseases that need site-specific targeting and to minimize side effects. Developmental considerations such as technologies involving upstream and downstream processes, development of novel delivery modalities like lipid nanoparticles, and designing well-controlled manufacturing facilities have progressed over the course of years to provide the best suited manufacturing processes for various injectable products. Supply chain management plays a pivotal role in ensuring product quality and viability. Discuss current trends in manufacturing parenteral drug products, innovative technologies for delivery systems, downstream processing technologies, and facility design considerations, along with trends and challenges faced by supply-chain management.