How does the Groton Biosystems Automated Reactor Sampling (ARS) system apply to the FDA's Process Analytical Technology (PAT) Initiative? PAT is an FDA program initiated to improve product quality, reduce costs and encourage implementation of factory automation in pharmaceutical and biotechnology
production - the ARS is designed to implement PAT in biotechnology by automating the sampling process which will increase sample frequency and lead to improved product quality.
Automation Potential
- Full Process Characterization
- Full Control Feedback Loops
- Higher Yields
- Lower Failure Rate
- Faster Processes
What can PAT/Groton Biosystems do for the industry?
- Improve Product Quality
- Increase Product Yield
- Reduce Manufacturing Costs
- Improve Process Knowledge
- Reduce Product Development Time
- Help companies align with the FDA "PAT" Initiative.
PAT and Return on Investment - More Efficient Manufacturing
- Greater Yield through Process Monitoring and Knowledge
- Greater Productivity - Performance Endpoints
- Higher Return on each Reactor Cycle
- Enable SPC
- Automated Feedback Control
|
