Process Validation in Manufacturing of Biopharmaceuticals

ANURAG S. RATHORE is a consultant of Biotech CMC Issues. He is also a faculty at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, process analytical technology and quality by design. He has authored more than 180 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and serves on the Editorial Advisory Boards for Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe and Separation and Purification Reviews. Dr. Rathore has edited books titled Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004) and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University. Gail Sofer: After serving as the director of Regulatory Services at BioReliance for 6 years, Dr. Sofer has recently joined GE Healthcare (formerly Amersham Biosciences) as the director of Regulatory Compliance in a new consulting team. Her publications include numerous articles and book chapters on downstream processing, virus inactivation, and validation. She has also coedited and authored several books. She serves on the Science Advisory Board of PDA, the Editorial Advisory Boards of BioPharm, BioQuality, and BioProcess International, and the Scale-Up Advisory Board of Genetic Engineering News. She chairs a PDA task force on virus filters and is cochair of the ASTM subcommittee on Adventitious Agents for Tissue Engineered Medical Products. She holds an M.S. degree in biochemistry from the University of Miami.

Guidelines to Process Validation. Commentary on the US Food and Drug Administration’s 2011 "Guidance for Industry, Process Validation General Principles and Practices". Applications of Failure Modes and Effects Analysis to Biotechnology Manufacturing Processes. Process Characterization. Scale-Down Models for Purification Processes: Approaches and Applications. Adventitious Agents: Concerns and Testing for Biopharmaceuticals. Lifespan Studies for Chromatography and Filtration Media. Validation of a Filtration Step. Analytical Test Methods for Well-Characterized Biological and Biotechnological Products. Facility Design Issues: A Regulatory Perspective. Validation of Computerized Systems. Process Validation with a CMO. Risk Management & Validation. Process Validation in Membrane Chromatography. Leveraging Multivariate Analysis Tools to Qualify Scaled-Down Models. Process Validation of a Multivalent Bacterial Vaccine: A Novel Matrix Approach. Validation of the Zevalin® Purification Process: A Case Study. Viral Clearance Validation: A Case Study.