Whitepapers

Pioneering Global Access to Cell and Gene Therapy Worldwide

Beyond Urban Centers: Expanding CAR-T Therapy with Decentralized Manufacturing

Abstract Chimeric Antigen Receptor T-cell (CAR-T) therapies are having remarkable success in treating certain cancers, but global accessibility to treatments like these is limited. This whitepaper examines the potential of a Decentralized Manufacturing Model (DMM) to address the distribution challenges that currently limit the widespread availability of CAR-T therapies, and

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Building a Sustainable Workforce for Decentralized Manufacturing: Perspectives from The Industry

Abstract This whitepaper explores both the challenges and opportunities associated with workforce development within the context of the Decentralized Manufacturing Model (DMM) for producing Advanced Therapeutic Medicinal Products (ATMPs). The ATMP manufacturing sector is currently facing a significant workforce deficit, emphasizing the urgent need for innovative and adaptive training models

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Enabling Decentralized Manufacturing of Autologous Advanced Therapy Products: A Review of Emerging Technologies

Abstract Advanced Therapeutic Medicinal Products (ATMPs), particularly Cell and Gene Therapies (CGTs), are pivotal in regenerative medicine. However, there’s a significant shortage in manufacturing capacity for these therapies. This paper discusses the transition from Centralized Manufacturing Model (CMM) to Decentralized Manufacturing Model (DMM), which could reduce costs and logistical complexities,

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Decentralized Manufacturing: Improving Access to Cell and Gene Therapies and Removing Barriers to Global Markets

Abstract Over the past decade, Advanced Therapeutic Medicinal Products (ATMPs), including Cell and Gene Therapies (CGTs), have revolutionized treatment options, particularly for patients with blood cancers. Despite their therapeutic success and substantial market growth, the current Centralized Manufacturing Model (CMM) poses accessibility challenges, especially for non-urban patients. Many patients face long waits or extensive

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