A Complete Guidebook on Automation in Biopharma Industrial Research

Dr. Dijendra Nath Roy completed his PhD from CSIR-Indian Institute of Chemical Biology, Kolkata, under the Jadavpur University of India and postdoctoral research at the National University of Singapore (NUS), Singapore. Dr. Roy started his career as an Assistant Professor in the Department of Bioengineering at the National Institute of Technology- Agartala, Tripura, India, in 2013, and presently, he is working as an Assistant Professor in the Department of Biotechnology at the National Institute of Technology - Raipur, Chhattisgarh, India. He has more than 25 peer-reviewed international publications along with being engaged as principal/co-principal investigator of more than five national projects on antimicrobial resistance and drug development funded by national agencies like the Department of Science and Technology (DST, Govt. of India), Department of Biotechnology (DBT, Govt. of India), Indian Council of Medical Research (ICMR, Govt. of India), etc. Dr. Roy has delivered numerous invited lectures at several international meetings in France, Belgium, Netherlands, Singapore, Malaysia, Thailand, Bangladesh, Maldives, and India. Dr. Roy has already been engaged in the guidance of five Ph.D. students in the field of antimicrobial resistance and drug development. Additionally, Dr. Roy has already contributed his enormous knowledge of antimicrobial drug resistance by publishing several artciels and two international books for academicians. Abhijit Ghorai is an experienced Biopharmaceutical Professional who brings in 19 plus years of diverse experience including Biopharma Research & Development, Operations and Life Science digitalization. He had been involved in Biopharma Drug Development, Quality Control, GMP Operations and Regulatory Filing for many years at various capacities. He had worked for global Biopharma MNCs like Biocon, Dr. Reddy’s, Lupin, Pfizer at various leadership roles. His area of research had been functional characterization of large molecule: Biologics: Novel Biological Entities (NBE) & Biosimilars. Currently he is focused into biopharma domain consulting and business analysis for automation opportunities, as part of Cognizant Life Sciences. By academic training, Abhijit is B.Tech and M.Tech in Biotechnology from Haldia Institute of Technology, Haldia (West Bengal University of Technology, West Bengal, India). He has completed his M.B.A. from Pondicherry University (DDE), degree awaited. He is CSM® and SAFe® certified Project Manager. He has also completed certification in Applied Business Analytics from Indian School of Business (ISB), Hyderabad, India. He has delivered multiple lectures in national and international conferences. He is also member of Board of Syllabi for different academic organizations.Partha Sarathi Ghosh is an Associate Director at Cognizant with 19 years of extensive experience in the IT services industry, particularly in the life sciences domain. He has played a significant techno-functional role, focusing on areas such as Laboratory Automation 4.0, Lab Informatics, LIMS and ELN implementation, OMICS Pipeline creation, and more. Partha has collaborated with various LIMS vendors and biologics platforms. He also has substantial experience in project management, product development, and vendor partnership. Partha has worked for several pharmaceutical clients, including Sanofi, Amgen, Merck, and AstraZeneca, contributing to lab digitization, process optimization, and GenAI implementation. Additionally, he has published multiple papers on AI/ML, NLP, optimization, parallel processing and bioinformatics. Partha serves as a reviewer for several journals.

• 1. AN INTRODUCTION TO BIOPHARMA INDUSTRIAL AUTOMATION2. JOURNEY OF BENCH TO BEDSIDE3. INDUSTRY X.0 => 5.0 ROADMAP IN BIOPHARMA4. AUTOMATION IN CORE5. DATA ENGINEERING IN BIOPHARMA6. CLONE DEVELOPMENT, CHALLENGES & AUTOMATION7. PROCESS DEVELOPMENT, CHALLENGES & AUTOMATION8. FORMULATION DEVELOPMENT, CHALLENGES & AUTOMATION9. STRUCTURAL CHARACTERIZATION OF BIOLOGICS, CHALLENGES & AUTOMATION10. FUNCTIONAL CHARACTERIZATION OF BIOLOGICS, CHALLENGES & AUTOMATION11. PROCESS TRANSFER TO PILOT PLANT, CHALLENGES & AUTOMATION12. BIOANALYTICAL METHOD QUALIFICATION IN R&D, TRANSFER TO QUALITY CONTROL & PROSPECTIVE AUTOMATION13. REFERENCE STANDARD DEVELOPMENT, CHARACTERIZATION, USAGE & PROSPECTIVE AUTOMATION14. PK-PD ANALYSIS OF BIOLOGIC DRUGS15. R&D DATA PACKAGE GENERATION FOR REGULATORY FILING & PROSPECTIVE AUTOMATION16. METHOD LIFE CYCLE MANAGEMENT & AUTOMATION17. CMC (CHEMISTRY, MANUFACTURING, AND CONTROLS) DIGITAL STRATEGY 18 X mAb CASE STUDY - AN AUTOMATION JOURNEY