During the production of recombinant biologics, it is important to ensure consistent quality throughout the entire life cycle of a product. In fact, regulatory agencies ask to demonstrate the clonal derivation of existing cell banks used in the manufacturing process.1,2,3
The more traditional technique of 2 rounds of limiting dilution4,5- with low seeding densities – is not only time-consuming but also costly. Other acceptable procedures include the use of the ClonePix system6, flow cytometry-mediated single cell sorting7,8 and automated cell imaging systems.9 With that said, some ongoing clinical programs employ legacy cell lines that were created before the industry had access to such practices and methods. Therefore, their cell line may not satisfy current regulatory expectations for clonality when filing for market access. In these cases, rather than changing altogether their cell line to ensure compliance, TLA-based solutions offer the opportunity to still perform monoclonality assessment.
Assessing clonal derivation of CHO cells with TLA published by Glenmark
Designing a monoclonality assessment
TLA-based solutions make strides in cell line development
For more information on how TLA can support your cell line development process, watch our latest webinar:
A single NGS-based solution for (CHO) clone selection and comprehensive characterization of transgene integrity, clonality and stability for cell line development
Recorded Thursday 20 May 2021