For a monoclonal antibody-based therapeutic an important aspect of an investigational new drug (IND) application, is demonstrating that the production cell line is clonally derived. In this webinar, the featured speakers will explore single cell cloning and its associated techniques.
There are several technologies/techniques that can be used to demonstrate clonal derivation. One prominent technique that has been used for many years, is the limiting dilution (LD). This is a common method of achieving clonally derived cells within the cell line development (CLD) process. In some cases, two rounds of LD are performed without the support of whole well imaging, or a single round is performed coupled with whole well imaging. CLD labs may be using a combination of LD for some projects and an automated single cell printer for others.
Regardless of how LD is implemented, it’s important to understand the theory, science and statistics behind it. More recently, automated single cell seeding, and high-quality imaging technologies have come to the fore, both as alternatives and as complementary tools to LD.
In this webinar, industry experts give their perspective on the following:
- How to interpret the data — for example, seeding at 0.5 cells per well doesn’t mean that 50 percent of resulting wells will be clonally derived
- How best to mitigate risks associated with LD — for example, the possibility of selecting a cell line that is not clonally derived
- Questions on clonality from the medicines regulator in an IND review
As the industry shifts away from LD, the speakers discuss the latest alternative technologies, namely automated single cell seeding and whole well imaging together with their practical, economic and commercial benefits.
