Combining a Compact Process Analytical Technology (PAT) Analyzer, Analytics, and Applications in a Quality by Design (QbD) Environment

Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current...

Chapter 18 Process Analytical Technology ( PAT ) and Quality by Design ( QbD ) Multi - and Megavariate Data Analysis

Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing

Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data analysis models, and applications of Raman spectroscopy, which have expanded the scope of Raman spe...

Chemometric Process Analytical Technology (pat) Applications in Bioprocess Engineering

The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies. The Food and Drug Administration’s (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new manufacturing technologies into pharmaceutical producti...

Antibody Analysis using microfluidic technology in high throughput Quality by Design Experiements

Current initiatives in Process Analytical Technology (PAT) and Quality by Design (QbD) are driving the need to identify and thoroughly understand the relation between Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs)1. Design of Experiment (DOE) studies to test the effect of cell culture changes on post translational modifications of monoclonal antibodies (MAb) or to moni...