Services and Solutions

Process Characterization (PC) Study

Process Characterization (PC) Study

Importance of PC STUDY

Recommended by FDA for product 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 of PC STUDY

Time
Significantly reduces time to FDA approval
Cost
Define process design space, ensures that the process delivers a product with reproducible vields and purity
Quality
Deeper understanding of your product during commercialization

BiBo Expertise

Offers Quality-by-Design driven PC studies.
Pioneer in the field of PC STUDY with 12+ years of hands-on experience in designing and executing PC projects.
Capability for scale-down modeling to 1L parallel platform for high efficiency PC experiments.
Upstream, downstream, formulation, fill&finish process and analytical characterization capabilities.
Next generation PC STUDY strategy that reduces time and cost by 30%-50% comparing to traditional DoE methods.