How to select a cell line to produce a biosimilar

Author
Published on

If you are developing a biosimilar of a recombinant protein, you need to select a cell line to produce your product. The easiest choice is to use the same cell line as is used to manufacture the reference product. However, if you cannot use the same cell line due to patent restrictions or business reasons – should you abandon your plans to develop a biosimilar produced in a different cell line? 

Upon reading this paper you will learn what regulatory authorities have to say on this and what pitfalls are lying on your path.

Explore Starodub updates

MEB Planning Tool Mandatory from 1 July 2025

ICH Q1A Guideline – Stability Testing of Drug Substances and Products – open for consultation

Meet Starodub at HollandBIO Dutch Biotech Event – 27 June 2025

Valentyna Starodub
Founder and Chief Executive Officer
Valentyna Starodub

Let's Connect

Talk to an expert