Featured Articles

Development and Implementation of Process Analytical Technology (PAT) Systems in the Biopharmaceutical Sector – Challenges and Returns

Sameer Talwar¹, Benoit Igne², Juan Aon³, Dave Stevenson³, Janice Fernandez³, Diana Ritz³, Tom Eyster³, Pramthesh Patel³

1. Manufacturing Simulation and Modeling Group, GlaxoSmithKline, King of Prussia, Pennsylvania, U.S.A. 19406
2. Process Analytical Technology (PAT) Group, GlaxoSmithKline, King of Prussia, Pennsylvania, U.S.A. 19406
3. Microbial Cell Culture Development (MCCD), GlaxoSmithKline, King of Prussia, Pennsylvania, U.S.A. 19406

Low Endotoxin Recovery: An FDA Perspective

By: Patricia F. Hughes, Ph.D.,Team Leader in FDA/CDER in the Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Colleen Thomas, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Kalavati Suvarna, Ph.D.,Senior Clinical Microbiology Reviewer in the Office of Antimicrobial Products within the FDA/CDER’s Office of New Drugs.
Bo Chi, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Reyes Candau-Chacon, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Candace Gomez-Broughton, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
Lakshmi Rani Narasimhan, Ph.D.,Reviewer in the FDA/CDER Office of Pharmaceutical Quality, Division of Microbiology Assessment.
FDA

Process Analytical Technology for Upstream Bioprocessing

Erica J. Fratz-Berilla
Staff Fellow
FDA/CDER/OPQ/OBP/DBRRII

Cyrus D. Agarabi
Regulatory Research Officer and Principal Investigator
CDER

Continuous processing optimization with smarter tools