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Biopharmaceutical Product Development

  Home   |   Biosimilar Scientific Workshops
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Biosimilar Scientific Workshops

Parallel Scientific workshops on Biopharmaceutical Product Development

Listen to industry and academia experts from the field of biopharmaceutical

Established Technologies

  • Formulation Development and Protein Excipients Interaction
  • Protein Aggregation and Biophysical Characterisation
  • Mass Spectroscopy for Protein and Peptide Characterisation
  • Cell-based Potency assays – design and considerations

Emerging Technologies

  • Challenges to Conduct Clinical Trials for Newer Therapies

Standard Workshops

  • Cell Line and Upstream Process Development
  • PAT, Data Analytics and Industry 4.0: Next Generation
  • Advances in Purification Technologies
  • Advances in Single Use Technology
  • Challenges and Opportunities in MSAT
  • FDA Compliance: Meeting regulatory expectations in product development and manufacturing

Agenda

Day 1: 02/02/2023 11:30-13:00 Session | Cell Line and Upstream Process Development | Venue: Mobor hall
Moderator: Dr. Sanjeev Gupta, Ipca Laboratories Ltd
Speaker Dr. Sivaprakash Ramalingam, CSIR-IGIB | Cell-line engineering using genome-engineering technologies
Dr. Ravi Mishra, CSIR-IMTECH | Emerging Cell Line Engineering technologies and their potential for High Yield Biopharmaceutical Production
Thermo Fisher Representative
Advanced techniques for media and process optimization for biologics manufacturing | Dr. Yaron Silberberg, Ajinomoto Genexine
Perfusion Medium Flexibility and Scale-Down Considerations |Mr. Christopher Brau, Thermo Fisher Scientific
Panel Discussion Dr. Venkata ramana, Reliance Lifescience
Dr. Sunit Maity, Syngene International Limited
Mr. Chistopher Brau
Dr. Yaron Silberg, Ajinomoto
Day 1: 02/02/2023 11:30-13:00 Session | Protein Aggregation and Biophysical Characterization | Venue: Bethul Hall
Moderator: Dr. Navaratna Vajpai, Biocon Biologics Ltd
Speaker Dr. Ashutosh Kumar, IIT-Bombay | HOS of Biopharmaceuticals in-formulation state by NMR spectroscopy
Mr. Pradeep Iyer, Hetero Biopharma
Dr. Vadiraja B. Bhat, Agilent Technologies India
Dr. Dama Venugopal Rao, Dr. Reddy's Ltd
Panel Discussion Dr. Ravishankara N, Sunpharma
Dr. Ashutosh Kumar, IIT-Bombay
Mr. Pradeep Iyer, Hetero Biopharma
Dr. Dama Venugopal Rao, Dr. Reddy's Ltd
Day 1: 02/02/2023 11:30-13:00 Session | PAT, Data Analytics and Industry 4.0: Next Generation | Venue: Grandball Room
Moderator: Dr. Parthasarathy Sampathkumar, Biocon Biologics Ltd
Speaker Model based Control of Continuous Bioprocesses | Dr. Anurag Rathore, IIT-Delhi
Applied biologics development and cGMP manufacturing with focus on transition to Industry 4.0 | Mr. Anshuman Bansal, Factorian
Raman PAT for Upstream Monitoring | Dr. Janice Tan, Merck KGaA
Dr. Manish Khandagale, Perkin Elmer
Panel Discussion Dr. Anurag Rathore, IIT-Delhi
Dr. Manish Khandagale, Perkin Elmer
Mr. Anshuman Bansal, Factorian
Dr. Janice Tan, Merck KGaA
Day 1: 02/02/2023 11:30-13:00 Session | Protein Aggregation and Biophysical Characterization | Venue: Bethul Hall
Moderator: Dr. Navaratna Vajpai, Biocon Biologics Ltd
Speaker Dr. Ashutosh Kumar, IIT-Bombay | HOS of Biopharmaceuticals in-formulation state by NMR spectroscopy
Mr. Pradeep Iyer, Hetero Biopharma
Dr. Dama Venugopal Rao, Dr. Reddy's Ltd
Panel Discussion Dr. Ravishankara N, Sunpharma
Dr. Ashutosh Kumar, IIT-Bombay
Mr. Pradeep Iyer, Hetero Biopharma
Dr. Dama Venugopal Rao, Dr. Reddy's Ltd
Day 1: 02/02/2023 14:30 - 16:00 Session | Mass Spectroscopy for Protein and Peptide Characterization | Venue: Bethul Hall
Moderator: Dr. Annu Uppal, USP
Speaker Dr.Pramod Wangikar, IIT-Bombay
Dr. Vaishali Sinha, Syngene International Ltd
Dr. Diane McCarthy, Senior Director, Global Biologics, US Pharmacopeia
Panel Discussion Dr. Bhavesh Vats, Lupin
Dr.Pramod Wangikar, IIT-Bombay
Dr. Vaishali Sinha, Syngene International Ltd
Dr. Diane McCarthy, Senior Director, Global Biologics, US Pharmacopeia
Day 1: 02/02/2023 14:30 - 16:00 Session | Advances in Single Use Technology | Venue: Grandball room
Moderator: Mr. Om Narayan, Kashiv Biosciences
Speaker Single use disposable BioSettlers for selective cell retention or primary clarification of CHO cells | Dr. Dhinakar Kompala, Sudhin Biopharma Co.
Approaches to intensification of next generation processes utilising single use technologies | Dr. Andreas Castan, Cytiva
Advances in Single Use Technology applied in Biopharmaceuticals | Mr. Sudeep Sen, Thermo Fisher Scientific
Mr. Ravindra Patel, OmniBRx Biotechnologies Pvt Ltd.
Panel Discussion Dr. Huzaifa Choonia, Stelis Biopharma
Mr. Prashant Godse, Lupin
Mr. Sethu Madhavan, Biocon Biologics
Dr. Dhinakar Kompala, Sudhin Biopharma Co
Dr. Andreas Castan, Cytiva
Day 1: 02/02/2023 14:30 - 16:00 Session | Advances in Purification Technologies | Venue: Mobor Hall
Moderator Mr. Gaurav Nagar, Serum Institute of India.
Speaker Dr. Rahul Bambure, CSIR-NCL
Mechanistic modelling for twin column continuous process | Mr. Vinay Pandey, Biocon Biologics Ltd
Mr. Larry Russo, Repligen Company
Scalable, Flexible and Reliable Solutions to Simplify Your m-RNA Production | Mr.Niddivinayak Mishra,Sartorius
Repligen representative
Panel Discussion Dr. Rahul Bambure, CSIR-NCL
Mr. Vinay Pandey, Biocon Biologics Ltd
Mr. Larry Russo, Repligen Company
Ms. Sirat Sikka, Thermo Fisher Scientific
Mr.Niddivinayak Mishra,Sartorius
Day 2: 03/02/2023 08:45-10:45 Session | FDA Compliance: Meeting regulatory expectations in product development and manufacturing | Venue: Grandball room
Moderator: Dr. Dhananjay Patankar, Independent Consultant
Speaker Regulatory Expectations for Biosimilar Manufacturing | Dr. Sarah McMullen, US-FDA
Pre-Approval Inspections for Biosimilars | Dr. Sriram Akundi, Biocon Biologics Ltd
Panel Discussion Dr. Swapnil Ballal, Q-Exl Partners
Dr. Shaligram Rane, Lupin
Dr. Sarah McMullen, US-FDA
Dr. Sriram Akundi, Biocon Biologics Ltd
Day 2: 03/02/2023 08:45-10:45 Session | Cell-based potency assay -designs and considerations | Venue: Bethul Hall
Moderator: Dr. Shubrata Khedkar, USP
Speaker Dr. Abhishek Mathur, Biolexis Pvt Ltd
Dr. Pallavi Karnik, Intas Pharmaceutical
Development of T-cell based bioassays | Dr. Nimesh Gupta, National Institute of Immunology
Surrogate potency assays using Biacore systems | Dr. Shubhendu Seal, Cytiva
Panel Discussion Dr. Shashwati Basak, Intas Pharmaceutical
Dr. Diane McCarthy, Senior Director, Global Biologics, US Pharmacopeia
Dr. Abhishek Mathur, Biolexis Pvt Ltd
Dr. Pallavi Karnik, Intas Pharmaceutical
Day 2: 03/02/2023 08:45-10:45 Session | Formulation Technologies and Excipients-Protein Interaction | Venue: Mabor Hall
Moderator : Dr. Sachin Dubey, KBI Biopharma
Speaker Vaccine development: improving stability to enable global access | Dr. Martinus Capelle, Johnson and Johnson
Dr. Nupur Mehrota, Premas Biotech
The viscosity reduction platform: Enabling subcutaneous (subQ) delivery | Dr. Smita Rajput
Panel Discussion Dr. Ajay Singh, Gennova Biopharmaceuticals
Dr. Rajendra Burki, Biological -E Ltd
Dr. Martinus Capelle
Dr. Nupur Mehorora
Day 2: 03/02/2023 14:15- 16:15 Session | Challenges in clinical trials for cell and gene therapies | Venue: Grandball room
Moderator: Dr. Gaurav Narula, Tata Memorial Hospital
Speaker Dr. Stephan Grupp, Children's Hospital of Philadelphia
Dr. Akshay Sharma, St. Jude Children's Hospital
Dr. Alok Srivastava, Christian Medical College
Panel Discussion Dr. Nikita Mehra, Cancer Institute (WIA)
Dr. Hasmukh Jain, Tata Memorial Hospital
Dr. Sattva Neelapu, University of Texas, MD Anderson Cancer Centre
Dr. Stephan Grupp, Children's Hospital of Philadelphia
Dr. Akshay Sharma, St. Jude Children's Hospital
Dr. Alok Srivastava, Christian Medical College
Day 2: 03/02/2023 14:15- 16:15 Session | Challenges and Opportunities in MSAT | Venue: Bethul Hall
Moderator: Mr. Vivek Farkade, BSV
Speaker CPV challenges and approach: MSAT perspective | Mr. Mayank Garg, Biocon Biologics Ltd
Criticality of MSAT in Evolving CDMO space | Dr. Mohan Kumar, Syngene International Ltd
Panel Discussion Dr. Prateek Gupta, Stelis Biopharma
Independent consultant | Dr. Narahari Rao,
Mr. Mayank Garg, Biocon Biologics Ltd
Dr. Mohan Kumar, Syngene International Ltd
Day 2: 03/02/2023 14:15- 16:15 Session | Special Guidance session by DCGI and RCGM on Biosimilars/Vaccine product approval | Venue: Mobor Hall
Moderator: Dr. Swapnil Ballal, Q-exl Partners
Chair: Dr. Nitin Jain, RCGM ( DBT-representative)
Guest: Dr. YK Gupta, Director AIIMS-Bhopal

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