Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK 21 structure for cell and gene therapy that can po- tentially handle millions and hundreds of mil- lions of patients. The investment in cell and gene manufacturing infrastructure capabilities will increase dramatically. Meurer (Biopharma Excellence): Enormous progress has been made in the application of CRISPR and gene-delivery technologies. One of the trends we're seeing is the combination of different technologies such as CRISPR, viral and non-viral gene delivery, and the potential of CAR-T and CAR-NK applica- tions for creating powerful therapeutic approaches. Progress in RNA-based gene delivery and trans- poson technology should not be underestimated either. Different gene modification and delivery tools are often used together. Chang (WuXi ATU): The [CGT] industr y is ex- panding rapidly, with emerging trends that can best be described as either therapeutic or pro- cess-based. Therapeutic advances, such as in vivo gene editing, were unheard of a few years ago, but some in vivo CRISPR/Cas9 therapeutics are now in the clinical phase. The growing prefer- ence for allogeneic over autologous cell thera- pies—including a llogeneic CAR T-cell t hera- pies—is another notable therapeutic trend. As for process-based trends, there's an increasing focus within cell and gene therapy to improve the scalability of manufacturing processes and reduce the costs associated with manufacturing. A similar focus is being paid within viral vector engineering and other production technologies to improve the quality of viral vectors in terms of packaging efficiency, infectivity, and even speci- ficity for a target cell type. References 1. S. Fried et al., "Patients With Out of Specification Tisagenle- cleucel Can Be Salvaged With Point-of-Care CART-T Cells: An Observational Intention-to-Treat Single-Center Analysis," pre- sentation at 2021 European Hematology Association Virtual Conference, EHA (Virtual, Aug. 15, 2021). 2. Stasiak, Andrzej. "Gene therapy," EMBO Reports, March 5, 2001. 3. FDA, "FDA Approves Novel Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss," FDA.gov, Press Release, Dec. 18, 2017. PT Pharmaceutical Technology presents the Drug Solutions Podcast, where the editors chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regula- tions related to the development and manufacture of drug products. In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology's science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies. In this discussion, Feliza Mirasol, science editor for Pharmaceutical Technology, explores innovative approaches, such as plant-made pharmaceutical manufacturing technology and organ-on-a-chip technology, that have been successful in enabling the development and manufacturing scale-up of biologics as well as some emerging therapies. Mirasol also discusses industry challenges, including cost considerations and development timelines, with Barry Holtz, PhD, Chief Scientific Officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technologies. Click HERE to listen to the podcast. Drug Solutions Podcast: Biologic Drug Development and Manufacturing

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