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Scale-up Process Design
Resolve Scale-up Issues
Scale-up issues can be challenging, when critical parameter behavior deviate from process development predictions or when totally unanticipated problems emerge during plant trials. We can leverage our experience and bring to bear our problem solving expertise to converge on solutions, working in close partnership with internal resources.
Create Robust Process Design
Building a robust process involves understanding the tolerance windows of Critical Process Parameters and sensitivity analyses of Critical Quality Attributes. It also requires determining the sources of variability and reducing them. We have experienced resources who can provide expertise.
RESOLVE SCALE-UP ISSUES
Process models
Design of Experiments
Process Simulations
Parameter sensitivity analysis
Tolerances and acceptable ranges
Comparability protocols and studies
CREATE ROBUST PROCESS DESIGN
Linking Critical Process Parameters (CPP's) to CQA's
Defining a multidimensional design space
Determining sources of variability
Establishing a process control strategy
Establishing a material control strategy
Creating a robust process design space
Our Popular Services
Technical Consulting Services
Business Consulting Services
DOE/ Scale-up
CAPAS
Tech Transfer
Risk Management
Validation
CGMP Audits
Patent, Investor Support
Fractional R&D, QA Leadership
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