The Evolution of Cell & Gene Therapy: Development and Manufacturing Insights and the Role of CDMOs
David McErlane, Group President of Biologics, Catalent, reacts to trends in cell and gene therapy development and manufacturing and comments on Catalent's ESG strategy to support people, the environment, and communities.
Sponsored by Catalent.
Contract Development and Manufacturing Organizations (CDMOs) play a critical role in advancing the field of cell and gene therapies by providing specialized expertise, state-of-the-art facilities, and scalable manufacturing solutions. Their technical knowledge and ability to adapt to evolving regulatory standards enable faster development timelines and ensure compliance, supporting biotech companies in bringing life-changing therapies to patients more efficiently. By leveraging their established infrastructure, CDMOs also offer cost-effective solutions that allow biotech firms to focus resources on groundbreaking R&D while reducing the need for significant investment in in-house production facilities. This combination of expertise, flexibility, and cost efficiency ultimately accelerates the path to market for innovative treatments.
As cell and gene therapies continue to revolutionize the treatment of previously untreatable diseases, key trends are shaping the future of manufacturing in this field. Streamlined regulatory approval processes, such as the anticipated FDA Platform Technology Designation Program, aim to reduce the time and complexity of bringing therapies to market. Advancements in automation, artificial intelligence, and digitalization enhance the efficiency, scalability, and reliability of manufacturing processes, reducing costs and barriers to patient access. Additionally, innovations in supply chain management improve reliability and traceability, ensuring timely delivery of these highly individualized therapies.
Looking ahead, the balance between insourcing and outsourcing in cell and gene therapy manufacturing is likely to shift, with many biotech companies prioritizing funding for core innovation rather than maintaining in-house production capacity. CDMOs with phase-appropriate expertise and facilities are positioned to become essential partners, particularly as companies seek to offset high development costs and manage the complexities of production. Allogeneic cell therapies, with their streamlined requirements, are especially well-suited to outsourcing, further underscoring the growing importance of CDMOs in the industry.
The commitment to Environmental, Social, and Governance (ESG) principles is another area where CDMOs like Catalent can demonstrate leadership. By fostering a diverse and inclusive workplace, minimizing environmental impact through science-based targets, and giving back to local communities, CDMOs align their operations with the broader goals of sustainability and social responsibility. Sustainable manufacturing practices, ethical sourcing, and robust governance frameworks further reinforce their dedication to ethical and environmentally conscious operations. This holistic approach not only builds trust with stakeholders but also supports healthier communities and a more sustainable planet.
Want to learn more? Watch episode 3 of this series here.
