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    Continuous Manufacturing in Biosimilars & Biologics

    Overview

    The biopharmaceutical industry is at a critical inflection point. While continuous manufacturing (CM) promises transformational benefits — from increased efficiency and reduced manufacturing costs to faster time-to-market — its adoption in biologics and biosimilars remains a complex journey. Unlike small molecules, large molecule manufacturing poses distinct challenges due to the intricacies of cell culture, purification, and product quality requirements.

    Transitioning from traditional batch processes to a continuous setup requires overcoming significant technological, operational, and regulatory hurdles. These include integrating new process technologies, redefining quality control strategies, adapting legacy systems, and navigating evolving global regulatory landscapes.

    This webinar is designed to address these pressing challenges head-on. Join us for a deep-dive session that demystifies continuous manufacturing in biologics and biosimilars — guided by industry experts sharing real-world insights, practical solutions, and regulatory perspectives.

    The webinar wll be conducted online from 1:00 pm to 5:00 pm on July 18, 2025. The webinar is being organised by Klinforsche Clinical and managed by Glostem.

    Why Attend?

    This webinar is tailored for professionals navigating the evolving biologics landscape. Whether you're exploring CM for the first time or refining an ongoing transition, this session will provide:

    -A 360° perspective on the technological, operational, and regulatory landscape of CM in biologics and biosimilars
    -Insights into overcoming industry-specific implementation hurdles
    -Strategies for achieving compliance while maintaining product quality and performance
    -Networking and Q&A opportunities with peers and subject matter experts
    -Step into the future of biologics manufacturing — with confidence.

    Register now to gain actionable insights and practical strategies for implementing continuous manufacturing in your operations.

    Contacts

    Technical Query: Ms. Tavleen Thakur, M: 7696125050, Email: t.thakur@glostem.com

    Participation Query: Ms. Swati Kanwar, M: 8289015050, Email: s.kanwar@glostem.com

                                     Ms. Farheen Zainab, M: 7696225050, Email: f.zainab@glostem.com

    Conference Date

    18-07-2025

    Satyanarayana S (Dr. Satyam)
    Satyanarayana S (Dr. Satyam)
    Professor - BITS Pilani Hyderabad, India
    Kajal Bhambhani
    Kajal Bhambhani
    Senior Consultant & Advisor - Regulatory Affairs - ex-VP DRL- Biologics, India
    Arvind Kushwaha
    Arvind Kushwaha
    Vice President and Head of Quality - Kemwell Biopharma, India
    Ritesh M Dhundi
    Ritesh M Dhundi
    Vice President, Manufacturing - Biological E Ltd. Hyderabad, India
    Iain Carmichael
    Iain Carmichael
    BioProcess Technical and Applications Leader, Asia - Cytiva, Singapore
    Shalu Kasliwal
    Shalu Kasliwal
    Founder & Managing Director - Klinforsche Clinical Science Pvt. Ltd., India

    Satyanarayana S (Dr. Satyam)'s Biography

    Satyanarayana S (Dr. Satyam)

    Professor

    BITS Pilani Hyderabad

    Satyanarayana S is a Microbiologist by training with a specialization in Molecular Biology and Protein Characterization. He obtained his PhD in Microbiology from the University of Illinois at Urbana Champaign and completed his formal training at Brookhaven National Labs at Long Island, New York in Protein Structure Function Studies.

    He joined Dr Reddy’s Laboratories in 2001 as an Associate Director heading the Molecular Biology group and over the years he rose to the position of Vice President and Head of Innovation and Scientific Initiatives. In the interim he also worked at Biocon Ltd. In Bangalore as Head of Quality Control and Microbiology from 2015 to 2016.

    He has extensive experience in Product Development and Operations for Biological Therapeutics, having played leadership roles in both Development (17 yrs) and Operations (6 yrs). He retired from his tenure at Dr Reddy’s on the 31st of March 2024 and joined BITS Pilani Hyderabad as a Professor of Practice in the Pharmacy Department.


    Kajal Bhambhani's Biography

    Kajal Bhambhani

    Senior Consultant & Advisor - Regulatory Affairs

    ex-VP DRL- Biologics

    With over thirty years of working experience, Kajal has established herself as a leading expert in Regulatory Affairs, Clinical Trials Management & Clinical Lab operations / accreditations.

    Currently, serving as an independent consultant in Pharma Regulatory Affairs and Clinical Research, she is also a certified Independent Director by the Indian Institute of Corporate Affairs (IICA).

    With over a decade of experience at Dr. Reddy’s Laboratories Limited, she has held diverse roles, including Head and Vice President- Global Regulatory Affairs,  project and program management, managing clinical development activities, and briefly handling the Pharmacovigilance function.

    As a Head -Regulatory Affairs, she was instrumental in collaborating with cross-functional teams to shape dossier content and provide regulatory guidance throughout asset development. She led the preparation, review, and submission of Marketing Authorization Dossiers in key regions including India, the US, EU, UK, LATAM, and ASEAN countries. Additionally, she played an active role in regulatory agency meetings with authorities such as the USFDA, EMA (Europe), PMDA (Japan), NMPA (China), and DCGI (India), ensuring compliance across all stages of drug development.

    She has earned recognition as a distinguished leader in her field, demonstrated by her accomplishments and roles across esteemed organizations, including Dr. Reddy’s Laboratories Ltd, Quintiles Phase 1 Clinical Trials Ltd, Lambda, Therapeutic Research, and Bayer Diagnostics India Ltd.\\\"


    Arvind Kushwaha's Biography

    Arvind Kushwaha

    Vice President and Head of Quality

    Kemwell Biopharma

    Arvind Kushwaha is a seasoned biopharmaceutical professional with over 23 years of industry experience, spanning research & development, manufacturing, and MSAT (Manufacturing Science and Technology).

    He has held key positions at globally renowned organizations such as Amgen, Lonza, Intas, and Dr. Reddy’s Laboratories, and recently as VP and Head of Quality for Biologics at Kemwell Biopharma. In this role, he was responsible for overseeing quality for both commercial and clinical biologic products.

    Arvind brings hands-on expertise in continuous manufacturing, having successfully implemented such a process at one of his previous organizations. The process received regulatory approvals from multiple global health authorities, including the U.S. FDA.

    His deep understanding of both traditional and advanced manufacturing systems, coupled with a strong regulatory background, makes him a valuable voice in the evolving landscape of biologics production.


    Ritesh M Dhundi's Biography

    Ritesh M Dhundi

    Vice President, Manufacturing

    Biological E Ltd. Hyderabad

    Ritesh has over 23 years of work experience in heading and delivering Drug Substance manufacturing for Biosimilars, proteins & peptides. He also led MSAT, spearheaded the efforts in onboarding cell retention device enabled commercial manufacturing for cell culture based products in India and is a leader in Chemistry, Manufacturing and  Controls ( CMC ). Prior to joining Biological E, he was associated with Dr Reddy’s Biologics Division, Hyderabad and Reliance Life Sciences Ltd, Mumbai. Ritesh holds a Master’s Degree in Biotechnology.


    Iain Carmichael's Biography

    Iain Carmichael

    BioProcess Technical and Applications Leader, Asia

    Cytiva

    Iain Carmichael is an accomplished bioprocessing expert with over 30 years of industrial experience, currently serving as the BioProcess Technical and Applications Leader for Asia at Cytiva (formerly GE Healthcare Life Sciences), based in Singapore.His expertise spans downstream hardware applications, with over a decade at Cytiva and more than 20 years of hands-on experience across laboratory, pilot, clinical, and large-scale manufacturing environments. Iain has played a pivotal role in monoclonal antibody process design, facility expansions, greenfield startups, and biopharma plant operations across Europe, the USA, and Asia.His career includes key technical roles at Lonza Biologics in both the UK and Singapore, where he contributed significantly to tech transfer, process development, commissioning, and qualification for leading biopharmaceutical clients.Iain’s current specializations include oligonucleotide processing, inline conditioning, ultrafiltration, lactoferrin production, and PCC/SMB chromatography. He is also well-versed in ensuring cGMP compliance and inspection-readiness for regulatory bodies across EU, US, and APAC regions.A graduate of the Open University, UK, Iain brings a unique blend of deep technical expertise and global biomanufacturing insight.


    Shalu Kasliwal's Biography

    Shalu Kasliwal

    Founder & Managing Director

    Klinforsche Clinical Science Pvt. Ltd.


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    Speakers & Panelists

    Satyanarayana S (Dr. Satyam)

    Satyanarayana S (Dr. Satyam)'s Biography

    Satyanarayana S (Dr. Satyam)

    Professor

    BITS Pilani Hyderabad

    Satyanarayana S is a Microbiologist by training with a specialization in Molecular Biology and Protein Characterization. He obtained his PhD in Microbiology from the University of Illinois at Urbana Champaign and completed his formal training at Brookhaven National Labs at Long Island, New York in Protein Structure Function Studies.

    He joined Dr Reddy’s Laboratories in 2001 as an Associate Director heading the Molecular Biology group and over the years he rose to the position of Vice President and Head of Innovation and Scientific Initiatives. In the interim he also worked at Biocon Ltd. In Bangalore as Head of Quality Control and Microbiology from 2015 to 2016.

    He has extensive experience in Product Development and Operations for Biological Therapeutics, having played leadership roles in both Development (17 yrs) and Operations (6 yrs). He retired from his tenure at Dr Reddy’s on the 31st of March 2024 and joined BITS Pilani Hyderabad as a Professor of Practice in the Pharmacy Department.


    Professor,  BITS Pilani Hyderabad,
    India

    Kajal Bhambhani

    Kajal Bhambhani's Biography

    Kajal Bhambhani

    Senior Consultant & Advisor - Regulatory Affairs

    ex-VP DRL- Biologics

    With over thirty years of working experience, Kajal has established herself as a leading expert in Regulatory Affairs, Clinical Trials Management & Clinical Lab operations / accreditations.

    Currently, serving as an independent consultant in Pharma Regulatory Affairs and Clinical Research, she is also a certified Independent Director by the Indian Institute of Corporate Affairs (IICA).

    With over a decade of experience at Dr. Reddy’s Laboratories Limited, she has held diverse roles, including Head and Vice President- Global Regulatory Affairs,  project and program management, managing clinical development activities, and briefly handling the Pharmacovigilance function.

    As a Head -Regulatory Affairs, she was instrumental in collaborating with cross-functional teams to shape dossier content and provide regulatory guidance throughout asset development. She led the preparation, review, and submission of Marketing Authorization Dossiers in key regions including India, the US, EU, UK, LATAM, and ASEAN countries. Additionally, she played an active role in regulatory agency meetings with authorities such as the USFDA, EMA (Europe), PMDA (Japan), NMPA (China), and DCGI (India), ensuring compliance across all stages of drug development.

    She has earned recognition as a distinguished leader in her field, demonstrated by her accomplishments and roles across esteemed organizations, including Dr. Reddy’s Laboratories Ltd, Quintiles Phase 1 Clinical Trials Ltd, Lambda, Therapeutic Research, and Bayer Diagnostics India Ltd.\\\"


    Senior Consultant & Advisor - Regulatory Affairs,  ex-VP DRL- Biologics,
    India

    Arvind Kushwaha

    Arvind Kushwaha's Biography

    Arvind Kushwaha

    Vice President and Head of Quality

    Kemwell Biopharma

    Arvind Kushwaha is a seasoned biopharmaceutical professional with over 23 years of industry experience, spanning research & development, manufacturing, and MSAT (Manufacturing Science and Technology).

    He has held key positions at globally renowned organizations such as Amgen, Lonza, Intas, and Dr. Reddy’s Laboratories, and recently as VP and Head of Quality for Biologics at Kemwell Biopharma. In this role, he was responsible for overseeing quality for both commercial and clinical biologic products.

    Arvind brings hands-on expertise in continuous manufacturing, having successfully implemented such a process at one of his previous organizations. The process received regulatory approvals from multiple global health authorities, including the U.S. FDA.

    His deep understanding of both traditional and advanced manufacturing systems, coupled with a strong regulatory background, makes him a valuable voice in the evolving landscape of biologics production.


    Vice President and Head of Quality,  Kemwell Biopharma,
    India

    Ritesh M Dhundi

    Ritesh M Dhundi's Biography

    Ritesh M Dhundi

    Vice President, Manufacturing

    Biological E Ltd. Hyderabad

    Ritesh has over 23 years of work experience in heading and delivering Drug Substance manufacturing for Biosimilars, proteins & peptides. He also led MSAT, spearheaded the efforts in onboarding cell retention device enabled commercial manufacturing for cell culture based products in India and is a leader in Chemistry, Manufacturing and  Controls ( CMC ). Prior to joining Biological E, he was associated with Dr Reddy’s Biologics Division, Hyderabad and Reliance Life Sciences Ltd, Mumbai. Ritesh holds a Master’s Degree in Biotechnology.


    Vice President, Manufacturing,  Biological E Ltd. Hyderabad,
    India

    Iain Carmichael

    Iain Carmichael's Biography

    Iain Carmichael

    BioProcess Technical and Applications Leader, Asia

    Cytiva

    Iain Carmichael is an accomplished bioprocessing expert with over 30 years of industrial experience, currently serving as the BioProcess Technical and Applications Leader for Asia at Cytiva (formerly GE Healthcare Life Sciences), based in Singapore.His expertise spans downstream hardware applications, with over a decade at Cytiva and more than 20 years of hands-on experience across laboratory, pilot, clinical, and large-scale manufacturing environments. Iain has played a pivotal role in monoclonal antibody process design, facility expansions, greenfield startups, and biopharma plant operations across Europe, the USA, and Asia.His career includes key technical roles at Lonza Biologics in both the UK and Singapore, where he contributed significantly to tech transfer, process development, commissioning, and qualification for leading biopharmaceutical clients.Iain’s current specializations include oligonucleotide processing, inline conditioning, ultrafiltration, lactoferrin production, and PCC/SMB chromatography. He is also well-versed in ensuring cGMP compliance and inspection-readiness for regulatory bodies across EU, US, and APAC regions.A graduate of the Open University, UK, Iain brings a unique blend of deep technical expertise and global biomanufacturing insight.


    BioProcess Technical and Applications Leader, Asia,  Cytiva,
    Singapore

    Shalu Kasliwal

    Shalu Kasliwal's Biography

    Shalu Kasliwal

    Founder & Managing Director

    Klinforsche Clinical Science Pvt. Ltd.


    Founder & Managing Director,  Klinforsche Clinical Science Pvt. Ltd.,
    India

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