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.
