Advanced Therapy Medicinal Products (ATMPs) will revolutionize 21st century medicine, as evidenced by several major scientific and clinical breakthroughs in the past decade.
By using cells as therapeutic agents, one can treat or cure an unprecedented variety of diseases or defects, even as a personalized therapy.
However, the complexity of living cell products makes the ATMP field equally challenging as it is promising.
Of the 10 ATMPs approved by EMA from 2009-2018, only 6 are currently still on the market, which is a waste of public resources as well as potentially life-changing therapies.
At present, ATMPs are typically not effective enough, as well as too expensive.
Personalized, closed and automated processes (i.e. industry 4.0) are often cited as a key facilitators towards the mitigation of these challenges.
A prerequisite for these processes, as corroborated in the Process Analytical Technology (PAT) initiative and statement by the FDA, is that the Critical Quality Attributes of the product can be evaluated cost-effectively, non-invasively, automatically, and in real-time.
However, there are no off-the-shelf sensor options for ATMPs that meet these criteria.
More advanced analytical methods such as Raman spectroscopy, impedance spectroscopy and soft sensing have been cited as promising monitoring methods for cell-based processing for over a decade.
There are two main challenges to the use of these methods.
In this project, we would like to address these challenges. Additionally, we will explore resource-efficient process optimization strategies.