Reproducibility, Reliability, Robustness: Establishing Cornerstones for Standardisation Of Cell Manufacturing

In the context of advanced therapeutic medicinal products, the ability to manipulate complex biological mechanisms provides therapy developers with a powerful tool to direct against various diseases.

However, to move forward and establish the true efficacy of cell therapies against specific indications, we must begin to understand which biological variables should be standardised to generate desired therapeutic outcomes.

In this on-demand webinar, we consider which manufacturing parameters have significant effects on product performance and suggest potential strategies to mitigate variability. There is also a discussion on the following:

• Minimising variability in cell manufacture
• The variability within the industry, such as groups manufacturing their own reagents and the need for potency assays
• The considerations for ancillary materials and the impact they can have on both process and product
• How should manufacturers evaluate these reagents to minimise variability of the final product?
• The variability of starting materials and hMSCs, how it impacts cell manufacturing and how to mitigate​