Its great promise for routine monitoring of biologic drugs begs the question: Just when will LC-MS analysis become a true bedrock analytical tool for scientists and technicians throughout biopharma?
Analytical data can be so much more than a historical point in time documented in a single report. In fact, biopharmaceutical organizations can use LC-MS data to build a continuum of compliance.
For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.
Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?