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:

We can help you identify the right host, and the right expression technology for your product
When you've screened for a high expressing clone and created a Research Cell Bank or Master Cell Bank, we can help you design a cell authentication protocol and help you find cost effective contractors to carry out the work
When the work is complete, we can help with the interpretation of the results and assist with testing and investigation of testing failures
- Articles:
- Presentation: Cell Authentication: Think of it as Career Insurance
- Blog discussion: Cell line authentication