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Process Characterization
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Process Characterization
Process Characterization
FDA Recommended
Truncate FDA approval time
BIB’s QbD driven PC studies
Importance
Recommended by FDA for product approval
Significantly reduces time to FDA approval
Ensures that the process delivers a product with reproducible yields and purity
Deeper understanding of your product during commercialization
Define process design space
Advantages
Justifies operating ranges and acceptance criteria
Minimize and aid in the investigation of deviations
Ensure product quality will not be impacted due to small operational variations occurred within the manufacturing process
Identifies key operating and performance parameters
BIB Expertise
Offers Quality-by-Design driven PC studies
Years of valued experience in PC projects
Capability for scale-down modeling to 1L parallel platform for high efficiency PC experiments
Upstream, downstream and analytical characterization capabilities
Don't Wait, Innovate
Alliance for People’s Health. United We Make Blockbusters
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