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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…