Cell and gene therapies (CGTs) are gaining strategic importance across the healthcare landscape, with oncology being the leading therapeutic area followed by cardiovascular and central nervous system (CNS) diseases. In 2024, regulatory authorities approved eight cell and gene therapies —including two cell therapies, two gene therapies, and three gene-modified cell therapies. Among them, Iovance Biotherapeutics’ Amtagvi, a T-cell therapy, is projected to reach $846 million by 2029 with a blockbuster potential by 2030. AAV remains the predominant viral vector in gene therapy, with recent funding trends favoring de-risked programs supported by strong clinical data and commercial viability. Yet, unlike monoclonal antibodies, CGTs have not undergone a manufacturing revolution that would enable faster, more automated production. The production of cell and gene therapies remains constrained by a limited talent pool and specialized infrastructure, necessitating outsourcing from small to large biopharma companies. The industry still faces significant operational hurdles: manufacturing scale-up, analytical bottlenecks, and complex supply chain dynamics. This is where large contract development and manufacturing organizations (CDMOs) play a vital role.
Manufacturing innovations that improve scalability and efficiency are essential to lowering production costs and ultimately drug prices— making CGTs more accessible to patients. The demand has shifted from mere capacity availability to advanced capability. CDMOs must now offer platform-based manufacturing, simplified tech transfers, AI-driven automation, and robust analytical services. Speed is also critical—traditional 18–24-month timelines are no longer acceptable.
Catalent is meeting these evolving customer needs through early-stage engagement and smart infrastructure use, offering end-to-end services from CMC planning and regulatory alignment to logistics and supply chain support. Catalent’s clinical to commercial capacity enables customers to ‘grow with Catalent,’ scaling their programs while supporting the evolving partnership needs of customer programs. Catalent’s scalable, cGMP-ready AAV platform minimizes late-stage challenges, enabling a seamless transition from development to clinical and commercial manufacturing on accelerated timelines. Catalent’s case management program is uniquely positioned to ‘think beyond manufacturing’, integrating draw-to-infusion logistics support to meet the nuanced demands of close-to-patient infrastructure for autologous cell therapies. Looking ahead, the success of CGTs will hinge on CDMO partnerships that combine deep expertise, operational agility, and strategic foresight—qualities exemplified by Catalent.
