Medical Devices

Cell Line Characterization

For a variety of very good reasons, not the least being regulatory, you should have good characterization of your cell line. Creating a production cell line for your product has been described as "the first commercial GMP task that you undertake, and you do it prior to Phase 1 testing!" Wait, it gets worse, it's usually done by the R&D group! We can help anticipate problems that you might have with your cell line, and design a program to provide phase appropriate testing and characterization so you have the data when you need it, and you're not at risk of a bad surprise late in your development program: