Personalised medicine – a production scale-up is the key to success

• The biotech and pharmaceutical sectors are gearing up to deliver some highly innovative new products but are facing one major challenge in particular: production scale-ups

• Automation would be a good solution but is very challenging in this context due to the high complexity of the manufacturing processes

• In this blogpost, we present four approaches to tackle these challenges

The biotech and pharmaceutical sector has high hopes for innovative therapies with brand-new products. To truly take advantage of this market potential, however, many companies are facing one major challenge in particular: production scale-up. In this blogpost, I list the major obstacles in this field – and share the four most promising approaches for a successful automation.

ATMP (advanced therapy medicinal products) and cell and gene therapy products are expected to see the greatest innovation in the coming years. If nothing else, this is reflected by the immense number of clinical trials currently underway in these fields. This market is therefore promising enormous growth and is a major focus in research.

Another example of this is the actual and projected market development in the field of regenerative medicine – where the rather new domain of tissue engineering is expected to see high levels of growth. To really take advantage of this market potential, however, many well-established companies and startups alike are facing one major challenge in particular: production scale-ups. A production scale-up is a way to manufacture products on a larger scale. This leads us to our current situation:

Current situation

Manufacturing these innovative products is highly complex and normally requires numerous cumbersome manual procedures and many qualified employees to do so. The high sterility requirements also mean that production has to take place in special clean rooms, generating high production costs and limiting the possible output. Because so many manual tasks are often required, the products are also susceptible to quality fluctuations. As with so many other industries already, the best and most successful manufacturing method for these products is automation.

Why is the transition from the laboratory to series production often so difficult?

Production scaling for capacities through automation is also the right path in the field of cell and gene therapy or tissue engineering. But what challenges come up along the way?

The following factors can make scaling more difficult: 

• Manufacturing processes involve a high degree of technical complexity, and there are no devices on the market that can efficiently carry out these processes. 
• Many process steps have never been automated before, so there is a lack of experience needed to determine whether a certain method will actually work.
• At first glance, simple manual steps cannot be automated one-to-one, such as with tweezers used in manual production to perform delicate procedures.
• Such processes require highly specific expertise – so if the process only has to be slightly modified for automation, the information needed to assess the effects of these changes is often lacking. 

Confronting the challenges associated with scaling therefore requires methods for automated solutions to perform these tasks to be found. Otherwise, you get stuck at the laboratory scale, and the product’s market price is much too expensive – or the product doesn’t make it to market at all.
 

Automation & production scale-up: which approaches are the most promising?

The following aspects are essential:

• For the automation of complex processes, working with many unknowns and constant changes is a given. The highly rigid, unidirectional development process often found in the health sector reaches its limits here. It takes agile approaches to complete continuous iteration cycles under controlled conditions. 
   
• Grasping the process: manufacturing processes are often highly complex in the biotech and pharmaceutical sector. Understanding this complexity and breaking it down into smaller, more manageable problems has to be the main driver in automation projects. Here at Zühlke, for example, we put this to the test in a project for Cutiss by developing a fully automated cell isolation device.
   
• It is essential to possess an interdisciplinary understanding of technology and biology in order to automate these processes. It is also imperative to understand and consider the various technical languages and approaches used by the automation specialists and in the academic world.


• A shift towards closed-system disposables: there needs to be a way to minimise/eliminate the numerous manual steps while, at the same time, allowing for production outside expensive clean rooms. Increasingly, this is taking the form of transferring production steps to closed-system disposables, which allow for a fully automated process workflow enclosed in a sterile disposable article. 

Conclusion

Before the market can truly be conquered with ATMP or cellular and gene therapy products, the sector still has several exciting and, indeed, quite challenging years ahead in the area of automation. This is true for many startups and big players alike.

Smart automation is the key to success, and this requires innovative, experienced partners. We want to enable to you take a big step forward in this topic: That’s why we offer you a one-hour free of charge “automatization check” with our experts.