In an earlier blog, we introduced the concept of Cell and Gene therapies (CGT) and touched on the current landscape and the many complexities that CGT involves.

Cell therapies are a promising field of medicine, with the potential to treat many different diseases. However, their manufacture can be complex and time consuming, which limits their availability and increases costs. This blog takes a closer look at the manufacturing process and discusses the potential offered by greater automation, as well as the challenges it presents.

 

Why consider automation?

The CGT landscape is currently progressing from the early stages of research into clinical stage research and commercialisation, bringing an increasing need to scale up manufacturing capabilities. Reflecting this evolution, manufacturing is seeing a shift from a more open, labour-intensive process into more automated protocols.

One of the key benefits of automation is that it can reduce the risks of human error and contamination. Producing cell therapies involves a large number of steps, including cell isolation, expansion and quality control. Each of these require precise and consistent handling. Since automation can ensure accuracy and consistency at every stage, it can make the manufacturing process faster, more traceable and more replicable, while also cutting the risks of variability and contamination that can make the final product less effective or safe.

 

One size fits few

Nevertheless, automation is far from being a simple, plug-and-play solution. Manufacturing cell therapies demands close attention to several key variables. These include the development stage of the product, its probability of success and the most suitable technology to use at different stages.

The source of the cells is also particularly important, because it helps to determine the best way to automate the manufacturing process. For allogeneic cell therapies, which are off-the-shelf products using cells from healthy donors, automation may offer a good way to increase production volume while also keeping tighter control of critical product attributes during the manufacturing process.

By contrast, autologous cell therapies are unique products that are created from the cells of the very patient to be treated. Here, automation may prove critically important in several areas, such as standardising protocols across the individual donor sources, making the therapeutic effect more consistent, reducing the manual labour required to produce a unique product for each patient, and processing parallel batches more efficiently.

 

Not just upside

Although automation has enormous potential, it also presents a series of challenges, starting with its cost. Technologies and systems that can automate human labour are expensive, so require significant up-front investment. This may present a major hurdle for smaller companies with limited resources or who only need to work with smaller batches.

Another consideration is timing. Automation that is introduced too early may not be able to handle the flexibility required in the early stages of research or discovery. However, if it is introduced too late, it can duplicate existing work and cause lengthy regulatory hurdles from authorities who require reassurance that the new technology does not affect the quality of the product.

In addition, different cell therapy development processes can vary considerably, depending on the developer. Such process variability makes it extremely challenging to create automated systems and technologies that are sufficiently flexible to accommodate the needs of different CGT developers.

 

Maybe try modular?

Fully automated, all-in-one solutions can offer significant benefits when it comes to standardisation, sterilisation and quality control. However, they may not provide optimal use of time, money or space. Moreover, they may not give developers the flexibility they need to build further capacity, thereby potentially limiting how much further they can scale up production.

Instead, a modular system can offer greater flexibility by allowing different systems to be used alongside each other, by enabling equipment to be repurposed or replaced, and by allowing individual steps in the process to be modified without necessarily needing to change the entire system. However, a good rule of thumb in cell therapies is that the less human intervention involved, the better. As such, a downside of modular systems is their greater need for human labour and its associated risks of potential errors and contamination.

 

The future is promising

In summary, elements of cell therapy manufacturing are now experiencing more demand, innovation, data and convergence. CGT developers that implement more automated systems are anticipated to have the upper hand over competitors, although this remains only one side of the coin. Reimbursement, accessibility, and associated services remain among the key determinants that dictate what products will finally reach the patients and, so far, only a handful of companies have managed to advance in this direction.

 

Our next blog will look at payment models for CGT and how do we make them affordable for patients, but also commercially viable for pharma companies. Make sure you’re following our LinkedIn to be the first to hear when we post.

 

Words by, Filippo Zordan, Shruti Singla, Jordan Lee and Stephanie Kocura


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