In-house manufacturing is a good option for cell and gene therapy (CGT) developers, according to researchers who say that, as well as providing better supply chain control, the approach is free of the oversight burden of working with contractors.
Outsourcing is an established practice in biopharma. But handing work to a third party is not always the optimal approach, according to Carol Houts, chief strategy officer at sterile manufacturing technology supplier GermFree.
“While outsourcing can be efficient for small developers with limited resources, some are deterred by the potential for bottlenecks or challenges caused by reduced oversight, as well as disruptions and delays,” notes Houts. “Of course, outsourcing to CMOs or CDMOs remains a viable option, especially for developers with longer lead times or those who can wait for capacity. However, the strategic advantages of in-house manufacturing—speed, control, flexibility, and risk mitigation—make it a preferred approach for many developers committed to advancing their therapies efficiently and reliably.”
The trick is to set up manufacturing capacity that is in line with the needs of the specific product.
Technology selection
“For cell and gene therapy developers setting up in-house manufacturing, key considerations include selecting appropriate, future-proof technologies and ensuring seamless integration of bioprocessing systems,” adds Houts. “It’s crucial to establish robust quality control measures, recruit and train a skilled workforce, design flexible facilities, and manage a reliable supply chain for raw materials and logistics.”
Cell and gene therapy developers should also opt for purpose-built bioprocessing technologies, rather than production systems designed for other types of therapy, Houts says, citing bioreactors as an example.
“Purpose-built bioreactors should specifically address the processing needs for CGT. These bioreactors should automate many manual tasks, reducing labor and manufacturing costs. In addition, effective digital integration ensures consistent batch quality and minimizes failures, leading to more reliable production,” she explains. “Also, purpose-built bioreactors support rapid optimization across various processes and cell types, with adjustable mixing mechanisms and flexible software. This allows for seamless transitions from research and development to full-scale manufacturing, speeding up the development process and enabling efficient scaling.”
These advancements in bioreactors and robotic solutions are poised to greatly improve CGT manufacturing, continues Houts. “By adopting these technologies, developers can make their processes more efficient and scalable, ultimately leading to better patient outcomes and wider access to life-saving therapies.”
In cell and gene therapy, maintaining sterile and adaptable production environments is crucial. One way of doing this while maintaining scalability is to use modular clean rooms.
“These units can be designed fit-for-purpose to meet specific production requirements and expanded as necessary, allowing developers to quickly adapt to changing production needs,” according to Houts. “They provide a flexible and cost-effective solution for clinical trials or small-scale production, ensuring that high standards are maintained regardless of location.”
Houts also suggests firms setting up in-house capacity should build systems that support artificial intelligence-based control.
“The consensus would suggest that these technologies would absolutely have a place within innovative CGT technology development, but that there just isn’t enough data or technological ‘readiness’ to allow a full-scale ‘movement’ toward the adoption of these technologies, as may have been seen in other areas. I’m sure it’s only a matter of time before we’re seeing the introduction of assistive technologies like these.”
