Cell and gene therapy (CGT) is one of the most promising and fastest growing sectors in biopharmaceutical industry. This is matched by increasing demand for novel technologies designed to improve workflow efficiency, while ensuring confidence in data. One of the requirements in the CGT manufacturing is ability to demonstrate product safety and consistency. The regulatory agencies expect that each therapeutic cell line is clonally derived, thus originates from a single progenitor cell. Traditionally, this was achieved by subcloning using limiting dilution (LD) method. However, due to the time and labor required combined with the low seeding efficiency and no evidence of clonality, many scientists are moving away from LD. Many alternative technologies utilise seeding and imaging of a single cell prior to dispensing. However, this approach often does not provide evidence of clonality, but only probability.

In this talk we will discuss how the latest developments from Advanced Instruments which provide solutions for single cell cloning, advanced cell detection, high-quality imaging, and data analysis. Our unique approach offers confidence in data and assurance of clonality as perfect solution for CGT in both process development and GMP-settings.