Innovative Quantification of Critical Quality Attributes.

Abstract

Potency testing is an important part of the evaluation of cellular therapy products. In vitro quantification of identified quality-related biomarkers is a technique often used at the laboratory. Nonetheless, the limited stability of most cellular therapy products, the lot variability and the limited time within which to perform testing are currently hindering their widespread use. Fortunately, within the last two decades, the evolution of material technology and miniaturisation processes has enabled the research community to shift the spotlight of attention towards the Lab-on-Chip concept for diagnostic applications. Such devices enable portable, rapid, sensitive, automated and affordable biochemical analyses aiming to advance the healthcare services across a broad application spectrum. However, it could be argued that the aspirations on their affordability are far from being exceeded, mainly due to the lack of a practical manufacturing technology. The Lab-on-Printed Circuit Board (Lab-on-PCB) approach has demonstrated enormous potential for developing economical diagnostic platforms leveraging the advantage provided by economy of scale manufacturing of the long-standing PCB industry. The integration capabilities that the PCB platform introduces to the Lab-on-Chip concept concerning the electronics and microfluidics seem to be unique. In this chapter, we will be reviewing the progress of Lab-on-PCB prototypes quantifying within miniaturised microchips a range of critical quality attributes with potential in potency testing. We will focus on their technology and applications whilst addressing the potential of this approach in practical use and commercialisation.