Continuous Manufacturing in Biosimilars and Biologics
  • Day1
Friday, 18th July 2025

13:00

Welcome Address

13:10

Technology and Advancements for Continuous Manufacturing
Satyanarayana S (Dr. Satyam), Professor, BITS Pilani Hyderabad, India

Explore cutting-edge innovations driving CM adoption — including intensified upstream processes (e.g., perfusion), continuous chromatography, automation, and real-time monitoring systems that improve scalability and product consistency.

13:40

Q/A Session

13:50

Manufacturing Challenges for Continuous Manufacturing
Ritesh M Dhundi, Vice President, Manufacturing, Biological E Ltd. Hyderabad, India

Understand the practical difficulties in adopting CM — such as maintaining cell culture performance, ensuring process robustness, integrating equipment, scaling operations, and reskilling the workforce.

14:20

Q/A Session

14:30

Quality Considerations for Continuous Manufacturing
Arvind Kushwaha, Vice President and Head of Quality, Kemwell Biopharma, India

Learn how to manage critical quality attributes (CQAs), define robust control strategies, handle batch definition, and ensure product comparability — all while leveraging Process Analytical Technology (PAT) and digital quality systems.

15:00

Q/A Session

15:10

Break

15:20

Regulatory Framework and Perspective for Continuous Manufacturing
Kajal Bhambhani, Senior Consultant & Advisor - Regulatory Affairs, ex-VP DRL- Biologics, India

Get up to speed on global regulatory trends from agencies like the FDA, EMA, and PMDA — including guidance on validation, control strategies, comparability, and lifecycle management specific to continuous manufacturing of biologics.

15:50

Q/A Session

16:00

Available Solutions to Enable Continuous Manufacturing
Iain Carmichael, BioProcess Technical and Applications Leader, Asia, Cytiva, Singapore

Discover enabling platforms, modular system designs, and collaborative approaches that support the transition to CM — from development through commercialization.

16:30

Q/A Session

16:40

Concluding Remarks
Satyanarayana S (Dr. Satyam), Professor, BITS Pilani Hyderabad, India

17:00

End Of The Webinar

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