As the biopharmaceutical industry shifts its focus toward cell and gene therapies, the manufacturing landscape presents both opportunities and challenges. While regulatory approvals have enabled the industry to make strides in disease treatment, there is an ongoing need to optimize and streamline manufacturing processes to ensure cost-effective and scalable deployment. The current challenges faced by cell and gene therapy (CGT) manufacturers include challenges associated with delivery system manufacturing, stability, and contamination control. However, disruptive approaches such as decentralized manufacturing, automation, disposable bioreactors, and digitalization of the supply chain are poised to revolutionize the industry.
The adoption of disposable production line technology alone has the potential to reduce costs by 25-30% and accelerate manufacturing by up to 60%. Leading companies, such as Cytiva, Sartorius, and Nucleus Biologicals, are actively exploring the benefits of single-use technology in CGT manufacturing.
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