Accelerating Biosimilar Success: Process Development & Validation Strategies with Cytiva Fast Trak™

In the upcoming decade, patents for many blockbuster drugs will expire, presenting manufacturers increased opportunities to manufacture biosimilars. However, biosimilar development has its own set of special challenges, including demonstrating high similarity with the reference product, speed of development, and process intensification.

In this webinar, we will review case studies that show successful downstream process development (PD) for Fc-fusion proteins and the conversion to single-use platforms for monoclonal antibodies (mAbs) as enabled by the Cytiva Fast Trak™ process development services (PDS) team. We will consider challenges around chemistry, manufacturing, and controls (CMC), processes that are designed to ensure a product meets target quality attributes. Finally, we will review the role of the Cytiva Fast Trak™ validation services team around the criticality of filter selection, understand what testing is required, if manufacturing limits are known, and the use of quality by design (QbD) approach (based on information gained through PD).

Presented by Morven McAlister, PhD Senior Director, Scientific & Laboratory Services (SLS) at Cytiva

Morven McAlister is the Global Director of the Regulatory and Validation Consultancy team at Cytiva. She joined Pall Life Sciences in 2001 and has held various technical leadership roles in microbial contamination control. She has extensive experience with sterilizing and virus filtration applications, including test design, qualification, regulatory guidance, and process-specific filter validation support. She is also actively involved in various industry task forces to standardize methods and technical positioning around microbial contamination control. She received her doctorate degree in microbiology from the Queen’s University Belfast and completed her postdoctoral research at the University of Arizona.

Uma Sinha Datta, PhD Fast Trak PDS India and Global Training Director, Cytiva

Uma Sinha Datta is the Director of Fast Trak™ PDS, India, and Global Training Manager at Cytiva. She joined GE Healthcare in 2008, and she currently leads a team of process development scientists who support customers in process optimization, scale-up, troubleshooting, and technical partnership engagements. As the Global Training Manager for Fast Trak training and education, she leads initiatives for the development and delivery of the in-person and online trainings for global customers to ensure ongoing knowledge transfer within the biopharmaceutical industry. Uma holds a doctorate degree in molecular virology from the Indian Institute of Technology, Kharagpur, and completed her postdoctoral research on cancer biology at the University of Kansas Medical Center.

Sponsored by Cytiva

At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16,000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers. Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com.