Key regulatory considerations for cell line and culture media for biosimilars
Date: 29th May 2025
Time: 11:30 AM SGT
Abstract
Biosimilar development necessitates navigating the complexities of ensuring your biosimilar process and product meets strict regulatory standards while matching the target profile to the highest degree possible.
The first critical step in this journey includes cell line development (CLD) and associated media optimization in order to align your biosimilar with the original product's attributes. There are advantages in utilizing a CLD process that utilizes animal component-free and chemically-defined media.
In this webinar, we will discuss:
- How to develop serum-free single-cell cloning processes to adhere to safety standards
- How to fine-tune media to empower your production objectives
- Regulatory concerns to navigate successful development and filings
Presenters
Melanie Sorensen
Regulatory Affairs Strategist Leader, Cytiva
Melanie Sorensen is a Lead Regulatory Strategist for Cytiva, and globally recognized Fortune 50 equipment and life sciences technology company. She is an active member of the Regulatory Affairs Professionals Society (RAPS) where she continually forms new connections. As a senior regulatory affairs leader, and a patient herself with deep connection to the oncology and cell and gene therapy communities, she has the unique ability to connects regulators, technology innovators, and patients voices in way that enables drug developers and service providers. Her unique ability has helped form lasting and authentic relationships with regulators, customers, suppliers and/or co-workers. Each year Melanie and her team lead more than 100 certification and registration submissions every year across FDA CBER/CDER, USDA, PMDA, EMA, EU Competent Authorities, SwissMedic, Health Canada, TGA, and other global health authorities. She is also a pioneering member of Cytiva Regulatory Science & Intelligence leadership team, which is focusing on enabling exceptional regulatory support to Cytiva customers.
Nan Lin, PhD
Director, New Technologies and Cell Culture Service Applications, Cytiva
Nan Lin, Ph.D. is the Director of New Technologies and Cell Culture Service Applications at Cytiva. She champions innovation management, focusing on evaluation and adoption of new technologies for Cytiva Cell Culture. She leads strategic collaborations with academia and industry for Cell Culture products and services. For over 20 years, Nan has served various roles in Cell Culture, from R&D to technical consulting. Nan holds a PhD in Toxicology from University of Minnesota.
Sheffali Dash
Principal Scientist, Cell Line Development and Cell Culture Services, Cytiva
Sheffali Dash brings over 20 years of experience in Cell Line Development (CLD), bringing products to market and taking complex molecules through the CLD process. Prior to Cytiva, she worked in R&D for Merck KGaA where she developed multiple cell lines including Mabs, Fc-fusion proteins, bi-specifics and biosimilars. In her current role, Sheffali is responsible for CLD projects as part of the Cytiva Cell Culture Services team. Sheffali holds a bachelor's degree in biochemistry and a master's degree in biotechnology. She is also an Industry Partner Advisory Council (IPAC) member in the Wentworth Institute's Biological Engineering department. In her free time, she enjoys baking and traveling.