Work Experience

ANURAG S. RATHORE is an Institute Chair Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His previous roles included management positions at Amgen Inc., Thousand Oaks, California, USA, and Pharmacia Corp., St. Louis, Missouri, USA. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, process analytical technology and quality by design. He has authored more than 700 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and Associate Editor for Journal of Chemical Technology and Biotechnology. He also serves on the Editorial Advisory Boards for Biotechnology Progress, Electrophoresis, BioPharm International, Electrophoresis, Journal of Chromatography B, Journal of Chromatography Open, Pharmaceutical Technology Europe, and Separation and Purification Reviews. Dr. Rathore has edited six books, namely Preparative Chromatography for Separation of Proteins and Peptides (2017), Process Validation in Manufacturing of Biopharmaceuticals (2012 and 2005), Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Electrokinetic phenomena: Principles and Applications in Analytical Chemistry and Microchip Technology (2004) and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University. Prof. Rathore is presently serving as Dean, Corporate Relations, at IIT Delhi.

Professor, Department of Chemical Engineering, IIT Delhi, New Delhi, India (December 2012 to present), Associate Professor (June 2009 to December 2012).

Created a group focused on Bioprocessing and Bioseparations. Our group consists of 15 postdoctoral fellows, 30 PhD, 4 M Tech and 10 B. Tech. students. Key topics include:

• Quality by design (QbD)

• Process analytical technology (PAT)

• Continuous processing

• Multivariate data analysis (MVDA)

• Computational fluid dynamics (CFD)

• Adaptive control of bioreactors

• Stability of biotech therapeutics

• Modeling of biotech unit operations

• Analytical and functional characterization of biosimilars

• Scientific and regulatory issues of biosimilars

• Data analytics

• Medical Imaging

• Pharmacoeconomics

• AI/ML applications in healthcare

Director: Process Development, Amgen Inc. (Mar 2003 - Jun 2009)

Led a group of 30 scientists and engineers that work in the different project teams for a late-stage project. Key activities for the group include:

• Creation of commercial process and analytical technology

• Process scale-up from pilot scale to clinical scale and from clinical to commercial scale

• Technology support for Phase III campaign

• Identification of a Third-Party Manufacturer (TPM) for commercial manufacturing if required

• Technology transfer to the TPM or other Amgen manufacturing sites

• Process characterization

• Process validation

• Regulatory filings: IND, Briefing Document, BLA, etc.

• Other activities leading to product launch including Pre-Approval Inspections

• Process Analytical Technology (PAT)

• Quality by Design (QbD)

Led a team that developed Amgen’s approach towards Process Characterization, Validation, In-Process Controls and Monitoring (CVIM) followed by implementation across Amgen’s manufacturing network for products under commercialization and legacy products.

Participated in creation of the Amgen Commercialization Process, including Commercial Process Development, Technology Transfer, and Process Comparability

Provide technical leadership and mentorship within the Process Development group by:

• Actively presenting and publishing in external conferences and journals

• Organizing sessions at major meetings

• Creating professional development opportunities for peers and junior staff

Senior Process Engineer, Bioprocess Sciences, Pharmacia Corporation (Feb 1999- Mar 2003)

Led Somavert Process Team to approval of the product from the EMEA (Nov 02) and FDA (Mar 03). Key activities included:

• Identification and validation of post-Phase III changes in the purification process

• Technology transfer from one Third Party Manufacturing (TPM) site to another

• Technology support for manufacturing of launch supplies

• Responses to queries from regulatory agencies

• Technology support for site inspection by EMEA and FDA

• Process validation and support of other critical activities leading to product launch

• Performed evaluation of different TPMs as possible manufacturing sites and performed process modeling for estimation of the COGS for use in site-selection

• Evaluated novel technologies, such as expanded bed adsorption (EBA) and osmotic shock

• Participated in due diligence of potential projects for in-licensing

• Supervised/ mentored staff

Research Assistant, Yale University (Aug 1994-Jan 1999)

• Conceived of novel applications utilizing cyclodextrins as selectivity enhancers in electrophoretic separation of proteins and peptides

• Established LC and CE methods for separating cis-trans isomers of peptidyl-proline containing peptides like Angiotensin I at temperatures of upto -20 °C and measuring kinetic parameters.

BIOSKETCH

Bioseparations and Bioprocessing Laboratory