BioProcess International

Minimum Sample Size To Lock Control Limits? A Capability- and Risk-Based Approach Using PpK and Chi-Square Uncertainty

A quantitative approach for linking baseline sample size to statistics provides a statistically justified basis for ...
BioProcess International

Integrating Quality by Design Principles into Gene-Therapy CMC Programs: Establishing Manufacturing Control and Comparability

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...
ISA

Author Q&A: Nonlinear Model-Based Control - Using First-Principles Models in Process Control

Author Dr. R. Russell Rhinehart discusses his new book, Nonlinear Model-Based Control: Using First-Principles Models in Process Control, and explains why nonlinear first-principles models should be ...