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.
Join this webinar to learn about single cell cloning, techniques to achieve clonal derivation and the industry thinking on clonality.
Arna Andrews PhD, Principal Consultant, Arna Andrews Consulting
Arna Andrews is currently working as a consultant to the Life Sciences sector, specialising in Cell Line Development and Biotechnology. Arna previously worked for CSL Limited, one of the world’s largest specialty biotech companies, where, from 2007 to 2019, she held the position of Director, Cell Line Development. In this role she was responsible for establishing and managing the global cell line development function at CSL Ltd/CSL Behring. Previously, (2000-2007) Arna held the position of Senior Scientist, at Zenyth Therapeutics Pty Ltd.Message Presenter
Paul Butler, Senior Product Leader, Advanced Instruments, LLC.
Paul has worked across functions in the life science industry including sales, field applications support and product commercialization with experience across a range of technologies including automation, imaging (cellular, multi-spectral and in vivo), label/label-free detection technologies and next-generation sequencing. Additionally, Paul has worked across many global territories including Europe, North America and Asia Pacific. Currently, he is working on the launch of several new Solentim products that will enable more consistency across the cell line development process and ultimately earlier patient access for novel therapeutics.Message Presenter
Who Should Attend?
Anyone working in cell line development and master cell banking for biotherapeutic drug products — especially roles that include achieving and demonstrating that cell lines from a process are clonally derived.
What You Will Learn
In this webinar, attendees will:
- Get an overview of tools to assist in developing clonal cell lines and their relative pros and cons
- Gain a better understanding of the underlying theory and science behind limiting dilution and potential pitfalls to avoid
- Learn from experts about their real-world experiences of providing evidence of clonality to the medicines regulator
Advanced Instruments is a global company offering a novel portfolio of analytical tools including, OsmoTECH®, a robust line of micro-osmometers to support bioprocessing and quality control (QC), and Solentim, a portfolio of best in class imaging and single-cell deposition technologies for cell line development workflows and assurance of clonality for regulatory bodies.