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Save the date: 22-23 April 2026
3rd Global Biologics India
Le Meridien, Hyderabad
22-23 April 2026
Note: Conference will start both days at 9AM
Check in will be open from 8AM
Breakfast would be served from 7 to 9AM
We will have two tracks on both days: One for Cell and Gene Therapy and other track on Mabs- Please click the button above for detailed and most up to date agenda.
Biologics: General Topics
Topic 1: Trends in Biotechnology
Topic 2: AI in Biotech- Endless opportunities
Topic 3: Regulatory and GMP Compliance
Topic 4: Facilities: How India can meet the world’s demand?
Topic 5: Raw Materials: Supply chain and the cost
Panel Discussion 1: Cell and Gene Therapy- Progress, Challenges, and Future Outlook
Panel Members:
Dr Dipankar Das, Director and Head, Global Biologics USP India
Dr Arun Anand, CGT Consultant (Ex COO Immuneel)
Emmanuelle Voisin, Ph.D., Founder and President, Voisin Consulting Life Sciences
Dr Raghu Malapaka,
Chief Business Officer, Nucelion Moderator: Coming soon
Panel Discussion 2: Cell and Gene Therapy- New Technologies- CAR T, CRISPR and next….
Panel Members:
Nedunchezhian Murugaiyan, Managing Director, Cytocare;
Akhil Kumar, MD, Chief Medical Officer, Aurigene Oncology Ltd;
Dr Renu Kundu, Director and CoFounder, East Ocyon (Moderator)
Emmanuelle Voisin, Ph.D., Founder and CEO, VCLS
Moderator: Coming soon
Module CGT 1: Cell and Gene Therapy: Challenges and Solutions
Topic 1: Promise of Cell and Gene Therapies: How to overcome barriers for wider adoption of these therapies
Speaker: Raghu Malapaka, Ph.D., Chief Business Officer, Nucelion, India
Topic 2: Harnessing Optical Genome Mapping for Innovation in Cell and Gene Therapy
Dr Rashmi Kanagal-Shamanna, Professor, MD Anderson Cancer Center, USA
Module CGT 2: NK Cells: Practical Solutions
Topic 1: Allogeneic Off-the-Shelf Cell Therapy — Potential, Status and Place in the Indian Landscape
Speaker: Renu Kundu, Ph.D., Director and CoFounder, East Ocyon
Topic 2:
Module CGT 3: CGT: BioManufacturing, Automation at Scale and Bioreactors
Topic 1: Invivo Lentiviral Gene Therapy
Speaker: Sanath Kumar. Team Leader, Microcrispr
Topic 2: CMC Innovation – A driver to develop a robust CGT manufacturing process
Speaker: Bhupal Reddy Auothu, VP and Head, CGT, Dr Reddys Lab
Topic 3: From innovation to adoption: Tumoroids as new approach methodology for cancer immunotherapy testing
Isha Dey, Ph.D., Senior Manager, Thermo Fisher Scientific
Module CGT 4: Stem Cells: Applications and Future Directions
Topic 1: Cell-Free Stem Cell Therapeutics: Advancing the Next Generation of Regenerative Medicine
Speaker: Dr Vishwas Kaveeshwar, Head, SDM University
Module CGT 5: Down-Stream purification and GMP Compliance for Cell Therapy products
Topic 1:Opportunities in Downstream Purification and GMP Compliance Challenges for Cell Therapy Products.
Mahesh Bhadane, Head Production Bulk, Advy Chemical
Topic 2 Phase Appropriate Quality Management System and GMP for Autologous CAR T Manufacturing
Speaker: Nithin Choudhary, Head Quality, CGT, Dr Reddys Lab
Topic 3: Downstream Purification and GMP Compliance for Cell Therapy Products
Speaker:: Dr. Prasad Kakarla,Global Product Manager – Ksep Technologies, Sartorius Stedim Biotech GmbH, Germany
Module CGT 6: CAR T cells: How to harness full potential-Next Generation of therapies
Topic 1:The Code is the Cure: Moving from Living Drugs to Injectable CAR Instructions
Dr Murali Addepalli, VP and CSO, Sanshi Bio
Topic 2: CARs, BiTEs, TriTEs, QuTEs… The Power of T cells
Dr Kishore Kunapuli, CSO Cell Therapeutics, Pulse Pharma
Module CGT 7: CGT: Regulatory and GMP Compliance
Topic 1: Comparing Global Regulatory Frameworks for Cell and Gene Therapies and India’s current landscape
Regulatory preparedness for personalised and point of care cell therapies
Speaker: Devesh Panwar, Head Reg Affairrs (CGT), Immuneel, India
Topic 2: Behind the Scenes of Life-Saving Cell and Gene Therapies: Why Quality matters
Pankaj Gupta, Head, QA, KodoLife Sciences
Topic 3: Regulatory Aspects (TBD)
Akhil Kumar, MD, Chief Medical Officer, Aurigene
Topic 4: CGT CMC Strategy – Where Regulatory complexity meets commercial reality
Sateesh GSV, Associate Director,CMC Regulatory Affairs, Syneos Health
Module CGT 7: CRISPR/New Technologies
Topic 1: Quality Challenges in CAR-T therapy, CRISPR and iPSC. Speaker: Deepak Sharma, DGM and Head QA, Microcrispr
Module CGT 8: Exosomes in Cell Therapy- New Updates , Development and Global Challenges
Topic 1:
Advancing Cell-Based and Cell-Free Therapeutics: Challenges and the Path to Commercialization
Speaker: Deepika Arora, Ph.D., Lab Director, RCRI StemCell
Panel Discussion 1: mAbs/Biosimilars: Analytics, Regulatory Inspection and GMP Compliance
Panel Members: Prasun Guha, VP Biologics Regulatory Affairs, Dr Reddy Lab;
Satish Makkina, GM, Biologics, Procell;
Atin Tomar; Yappan Bio
Dr Sankaranarayanan Srinivasan, CoFounder and Director, Proantek;
Nageswara Rao, VP, Reg Affairs, Hetero Drugs;
Dr Ranjan Chakrabarti (MODERATOR), Biopharma and Discovery, Consultant
Panel Discussion 2: AI and Biologics: From Bench to Clinical Trials
Panel Members: Prashant Chawla, Sr GM, Manufacturing, Biological Evans
Dr Amit Jogi, VP and Head, Aurigene;
Dhananjay Patankar, Consultant and Former VP, Syngene;
Sanjay Shah, Founder, XenPharm;
Seema Bhandarkar, Head Aurigene (Moderator)
Sateesh GSV, Associate Director, CMC Regulatory Affairs, Syneos Health
Moderator: Coming soon
Module MAB 1: Upstream and Clone Development
Topic 1: Control Strategy Frameworks and Their Critical Importance in Bioprocessing: Speaker: Harshit Shah, Group Lead, MSAT, Dr Reddys Lab
Topic 2:Advancing Bioprocess: Next-Generation Cell Culture Strategies Chandrashekhar KN, Director, Cell Culture R&D, Biocon Biologics
Topic 3 : Driving Process Intensification with Advanced Cell Line Development
Speaker: Divay Bagga, Global Product Excellence Mgr, CLD Service, Sartorius
Module MAB 2:New Tools and Product Development
Topic 1: Best Practices and Tools to Support Consistency of Host Cell Protein Analysis by Mass Spectrometry
Speaker: Dr Sameer Kumar, Manager and Team Lead, Analytics, USP, India
Topic 2: Advancing Bioprocess: Next-Generation Cell Culture Strategies
Speaker: Chandrashekhar K N Director, Cell Culture R&D, Biocon Biologics
Topic 3: Advanced characterization methods for novel biologics – Now, next or never?
Speaker: Dr Arpana Dutta, Director/Group Lead, Syngene Intl Ltd
Topic 3:Tools and Technologies to Drive Advancements in Biopharmaceutical Drug Development
Dr. Ashish Pargaonkar
Application Workflow Specialist
Agilent
Module MAB 3:BioAnalytics: New waves
Topic 1:From Development to Routine Use: USP Bioassay Chapters and Standards Across the Assay Lifecycle
Speaker: Dr Shubrata Khedkar, Asso director, BioAssay and Mol Biol, USP, India
Topic 2: Mitigating Matrix Effects in Pharmacokinetic Methods: A Novel Approach for Accurate Analyte Quantitation in Disease Matrices
Speaker: Mansi Jakhade, Analytical Project Manager, Dr Reddys Lab
Topic 3: CMC Analytical for Biologics/Biosimilar Development and shared brief
Speaker: Sabyasachi Halder, Consultant
Topic 4:Presentation by Agile on Protein Characterization
Sourav Majumdar, Ph.D.,
Associate Technical Director
Agile BioSciences
Module MAB 4: Risks and Controls: Manufacturing and Purification
Topic 1: From Risk to Control: Implementing Closed Process Architecture and Contamination Control Strategy in mAbs and bsAbs Downstream Purification
Amit Jogi, Global Head, CDMO Biologics, Aurigene
Topic 2: From Early Discovery to Manufacturing:
Addressing Variability in mAb
Development and Control Strategies
Lianbin Chen, TSS Head
Acro Biosystems, USA
Module MAB 5: AI- Endless opportunites
Topic 1: AI Transformation for Business Agility in Pharma: Speaker: Seema Bhandarkar
Head Prog and Alliance Mgmt
Aurigene
Topic 2: Accelerating Biologics Design through Computational Modelling
Dr Abhijit Kayal,Schrodinger
Module MAB 6: Manufacturing- Batch to Continuous mode-What is next?
Topic 1: Batch, Fed‑Batch, and Perfusion Manufacturing Processes in Biopharmaceutical Production Speaker: Mradul Tiwari, Sr Manager, Sun Pharma
Topic 2: Scale-up of biopharma operations in India’s ecosystem; beyond the bioreactor scale-up
Sanjay Shah, Founder, XenPharm Services
Topic 3: Closed Processing – Enabler for NextGen biomanufacturing
Somasundaram G
Principal Consultant, Merck
Module MAB 7: BioAnalytics: New waves
Topic 2: Reserved for Sponsors
Module MAB 8: Bio-Manufacturing/Automation/Digital Tools/Cost Reduction
Topic 1:Raw Materials: Supply Chain and the Cost
Speaker: Sambi Reddy, CellTricks
Topic 2: Multiplexing Optical Methods in Prometheus Panta for complete Protein characterization
Saji Menon, Ph.D., Sr Application Scientist, NanotemperTechnolgies
Topic 3: Enhancing Protein A with Chromatographic clarifiers: A Next Gen Clarification Approach
Jobin Maliyil, Bioprocess Application Scientist, 3M
Module MAB 9: Process Validation, CMC and Regulatory Compliance
Topic 1: GMP and Regulatory Compliance
Mahabubi Shadick, President, Quality Operations,
Topic 2: Sweety Mathew, Global RA CMC Lead, Novo Nordisk
Topic 3: Latest Regulatory Advancements in Biosimilars
Swapna Teja Gundala
Manager – Regulatory Affairs
Parexel International
Some of the topics/ titles of talks that would be discussed….
Recent Advances in Process Development and Next Generation Manufacturing for Accelerated and Affordable Biosimilar Development
Successful Commercialization of Cell Therapy products in India
Overview of upstream process development for Biosimilars
Successful Cell Therapy Program: challenges associated with drug manufacturing and process and product characterization
Manufacturing of AAV and lentiviral vectors using HEK293 cells
Challenges in process development of CAR T cell therapy
Induced Pluripotent Stem Cells in Regenerative Medicine
NK and Gamma Delta T based Allogenic Cell Therapy
Decoding the future of Healthcare; A comprehensive survey of cell therapy outcomes
Product development: commercialization and market
Regulatory Inspection – Challenges and Opportunities for Biosimilar Products
Regenerative medicine drug development in India: Challenges and Opportunities
Novel Biologics Development- A case study
Strategizing the challenges during clone development
Current challenges of development and cGMP manufacturing of Cell and Gene Therapy products
Induced Pluripotent Stem Cells (iPSC) In Disease Modelling and Drug Discovery
Bioassay: Advancement in functional assessment of biologics and regulatory requirements
Beyond the Blueprint: AI-Powered Protein Engineering for a Brighter Future
Scalable & Efficient Production of Lentiviral vectors
Collaboration of IP and Biosimilar R&D for Early Market Access
Bringing best practices to India in Design of Biopharmaceutical Facilities
Translating Cell and Gene Therapies- From Concept to Commercialization
Agenda from Past Conferences