eBook - A Guide to Improving Biotech Processes with Process Mass Spectrometry Gas Analysis

Process Analytical Technology Program

The FDA’s Process Analytical Technology (PAT) initiative promotes improved process understanding by defining Critical Process Parameters (CPP) and monitoring these CPPs, either in-line or on-line. Processes can become more efficient, with reduced over-processing and greater product consistency. Gain productivity by instituting a PAT program that is simple, data rich, and low-risk.

Process Mass Spectrometry Gas Analysis:

• Track batch progress in real-time
• Pinpoint contamination and maximize visible cell mass to increase profits
• Reduce over-processing/waste
• Increase product consistency with fault-tolerant operation