Dr. Nandu Deorkar, senior vice president, research & development at Avantor, addresses the manufacturing challenges that remain when developing cell and gene therapies at scale.
Key insights:
- There is a need for process standardisation in production systems to improve scalability, and closed so they are less exposed to failure modes.
- Developing partnerships with providers as soon as possible should increase process efficiency and minimise later missteps.
- There is considerable raw material expense associated with components such as plasmid DNA, so that potentially harmful or adventitious agents cannot be introduced through the raw material supply chain.
One of the most exciting and revolutionary trends driving biopharmaceutical growth and innovation is cell and gene therapy. It is exciting not only because of the growth of successful trials and approved therapies, but also for the technology’s ability to impact patients’ lives.