3 questions with…
Co Founder & Chief Executive Officer
What are the biggest challenges in the advanced therapy industry?
The industry is suffering from a product consistency issue, which is the reason why costs are so high and clinical translation has been limited. There is a lack of tools that enable both high-throughput research and translation to the manufacturing scales. The research tools such as flask and multi-wells are prone to yielding inconsistent results because of multiple manual operations, lack of online analytics, etc. This means research is slow to reach product consistency, even at a small scale. Then, when people move to manufacturing tools, they have to restart the process discovery all over again, because cells behave differently in larger volumes. It is very expensive to scale up, because these tools guzzle reagents and take up a lot of cleanroom space. This means that only a small portion of the cell process space can be explored and so the product consistency suffers. Some treatment batches still have 20-30% fail rate due to product not meeting its specifications. This missing link between research and manufacturing is the core issue of product variability.
What advanced therapy innovations are you most excited about?
I am excited about the push for automation and digitalisation for cell therapy research and manufacturing. This makes it possible to accumulate, analyse and exploit data that will surely lead to massive improvements in product consistency and costs, but also might give us new insights about the biology itself.
What are your predictions for the next 5 years for the Advanced Therapy Industry?
I wouldn’t be able to make any predictions given how fast the market is developing. But I believe the next 5 years will be make or break for this industry. Very large investments have already been made over the last 5-10 years, and with a potential recession looming, cell and gene therapies are going to have to demonstrate scalability beyond rare diseases and second- and third-line treatments. For this, we need research tools that enable fast process development and manufacturing tools that scale from research.