Advancing Biosimilars with Confidence: Leveraging Expert Characterization, Bulk Harvest Testing and Regulatory Support
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Join Us!
As the biosimilar market continues to expand, developers face increasing pressure to generate robust analytical and biosafety data while accelerating timelines to IND and BLA submissions. Selecting the right testing partner can be critical to reducing development risk, meeting regulatory expectations, and avoiding costly delays.
Join experts from Sartorius to explore how outsourced analytical characterization and GMP testing can support successful biosimilar development from early characterization through commercial manufacturing.
This webinar will highlight the importance of comprehensive biosimilarity assessment, how cell bank manufacturing and testing provide the foundation for compliant biologics production and the critical role of bulk harvest testing in ensuring batch safety and process control.Attendees will learn how Sartorius' extensive experience supporting more than 800 clients, contributing to approximately 50 regulatory submissions, and providing direct access to scientific and regulatory experts can help accelerate development timelines while maintaining quality and regulatory confidence. Through a collaborative partnership approach, we work closely with clients to navigate complex testing requirements and support successful progression toward regulatory milestones and commercialization.
What You’ll Take Away
In this webinar, discover how the right testing and characterization strategy can help you:
- Strengthen your biosimilarity assessment : Understand how comprehensive analytical characterization can support confident comparability and biosimilar development decisions.
- Build a compliant cell bank foundation: Learn how robust cell bank manufacturing and characterization can support consistent, safe and regulatory-ready biologics production.
- Improve batch safety and process control: Explore the role of bulk harvest testing in identifying potential contamination risks and supporting quality throughout manufacturing.
- Accelerate your path to IND and BLA milestones: See how phase-appropriate, cGMP testing and ready-to-use assays can help reduce testing timelines and development bottlenecks.
- Navigate regulatory expectations with greater confidence: Gain insights from experts with extensive experience supporting global regulatory submissions and biologics testing programs.
- Build confidence into every stage of your biosimilar journey: Join our experts to discover how the right characterization, testing and regulatory support can help you reduce development risk, accelerate timelines and move toward regulatory milestones with greater confidence.
Register now to secure your place.
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Highlights
- Gain valuable insights and explore practical applications through scientific talks.
- Explore cutting-edge solutions at our product demonstrations and exhibition.
- Connect & engage with industry experts and peers to discuss innovative strategies for utilizing Sartorius' solutions.
Sessions
Agenda
Esteemed Voices From the Industry
Our selected experts will share insights on the latest trends, challenges, and developments in this dynamic field. Engage in unique discussions, learn about cutting-edge scientific discoveries, and explore the future of biopharmaceuticals with these influential thought leaders.
Joel Watkinson is the Product Manager for Testing and Cell Bank Manufacturing Services at Sartorius.
Following a PhD in Immunology, Joel has held scientific, commercial, and global product management roles supporting biologics and advanced therapies. His experience spans biologics testing, cell bank manufacturing, antibody products, GMP cytokines and growth factors, and therapeutic modalities including monoclonal antibodies, stem cell therapies, and immune cell therapies.
For the past five years at Sartorius, Joel has managed the testing and cell bank manufacturing services portfolio, working closely with scientific, quality, regulatory, and commercial teams to align service offerings with customer needs, and industry and regulatory requirements. His focus is helping clients streamline development, support regulatory readiness, and progress their products toward clinical and commercial milestones as efficiently as possible.
David Stewart leads the Biophysical characterisation & Genetic Stability teams at Sartorius.
Over the previous 12 years, David has worked in a number of roles supporting protein based therapeutic products throughout the drug-life cycle.
David began his career in novel drug development, focussing on the analytical development and characterisation of novel antibody and antibody-like proteins including bispecifics and biobetters. Over the past 6 years David has focussed on deep analytical characterisation within a GMP compliant structure. Acting as a consultative support, his focus is creating deep understanding or products to allow seamless transition from product conception through to commercialisation.
David's teams have a wealth of experience supporting custom method development, validation and biosimilar comparability studies across multiple products and disease modalities.
Kirsty Lindsay leads the Virology team within the Biosafety Testing Department at Sartorius Stedim BioOutsource Ltd. With more than 18 years of experience in biosafety testing, she has supported the testing and characterisation of a wide range of biological therapeutics.
Kirsty has extensive expertise in GMP-compliant regulatory testing, with particular focus on cell bank and bulk harvest testing for protein therapeutics. In her current role, she leads a scientific team dedicated to delivering reliable, high-quality testing services that help ensure product quality and safety. She also works closely with clients to develop and communicate effective testing strategies, providing scientific guidance and support to help meet their regulatory requirements.
