gene editing Archives - Medical Design Sourcing

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Oncology may continue be one of the hottest sectors across the pharma sector, but other therapeutic areas are catching up in terms of innovation and investment. While oncology and hematology jointly accounted for about one-third of the new FDA approvals in 2023, investors are increasingly betting on precision medicine, advanced drug delivery systems and the use of AI and machine learning for drug discovery and development.

The shift is not entirely new. In a report from late 2023, McKinsey also notes ML-enabled drug discovery, cell therapies, and gene editing continue to attract significant funding, making up over two-thirds of biotech VC deals in 2022, constituting $15.5 billion in total. The consultancy also noted that immunology had displaced oncology as the hottest therapeutic area for asset-based biotech investments, also citing allogeneic cell therapies …

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Cell and gene therapy (CGT) manufacturing is rapidly transitioning from scientific curiosity to clinical reality. But the manufacturing complexity of CGTs far outpaces traditional biologics production, presenting a multifaceted challenge that is part scientific, part technological. “The manufacturing process for cell therapies and gene therapies is infinitely more complex than it is for let’s say, monoclonal antibodies or recombinant proteins,” said Betty Woo, vice president and general manager of cell, gene, & advanced therapies at Thermo Fisher Scientific.

Despite the complexity, much of the current cell therapy manufacturing process relies on manual procedures. “Manual intervention introduces a level of human variability,” Woo said. “This not only leads to inconsistencies, but also increases the risk of human error.”

While manufac…

gene editing

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The shift from manual to machine learning in cell and gene therapy drug discovery