Enzyme replacement therapies have transformed the treatment landscape for many rare genetic and metabolic disorders by addressing enzyme deficiencies that drive disease progression. By supplying a functional version of a missing or deficient enzyme, these therapies can restore critical biological processes and improve patient outcomes. However, developing and manufacturing enzyme-based biologics presents unique challenges beyond those of many other protein therapeutics. This webinar explores the strategies used to preserve enzyme functionality across the manufacturing lifecycle.
The featured speaker will discuss the key development and manufacturing considerations involved in bringing enzyme replacement therapies from early development through commercial manufacturing. Attendees will gain insight into the scientific factors that influence enzyme functionality, including protein folding, stability, structural integrity and post-translational modifications. The session will explore why maintaining enzymatic activity is a critical quality attribute and how development teams evaluate and monitor activity throughout the program lifecycle.
The webinar will also examine manufacturing strategies designed to preserve enzyme performance during production, including expression system selection, analytical methods used to assess structural and functional characteristics and downstream purification approaches that minimize activity loss while achieving product quality requirements. Because enzyme function can be affected by subtle changes in process conditions, special attention will be given to process development considerations that support enzyme stability throughout manufacturing.
As programs progress toward larger manufacturing scales, development teams must ensure that enzymatic activity remains consistent across batches and production campaigns. The session will review process monitoring, activity-focused analytical testing and process characterization strategies that help maintain product performance during commercial manufacturing. Attendees will also hear a real-world example of how process optimization and purification improvements helped preserve catalytic activity and support successful manufacturing scale-up.
Register for this webinar to learn how enzyme replacement therapies can maintain enzymatic activity through development, scale-up and commercial manufacturing.
Who Should Attend
This webinar will appeal to professionals across the following roles and organizations:
MSAT (Manufacturing Science & Technology)
Process Development Scientists
Upstream and Downstream Development teams
Bioprocess Engineers
Analytical Development Scientists
CMC and Technical Operations leaders
Pharmaceutical Manufacturing professionals
Quality and Regulatory professionals
Program and Project Managers
Biologics Development leaders
Biotechnology companies
Rare Disease and Genetic Medicine Developers
Biopharmaceutical organizations
CDMOs and Contract Manufacturing partners
Translational and Clinical Development organizations
What You Will Learn
Attendees will:
Understand the unique development and manufacturing challenges associated with enzyme replacement therapies, including protein folding, stability and enzymatic activity
Learn how process development and analytical characterization strategies help maintain enzyme function throughout manufacturing
Explore purification and downstream processing approaches designed to preserve catalytic activity while meeting product quality requirements
Discover scale-up considerations and best practices for ensuring consistent enzyme performance across manufacturing runs
Register free on Xtalks:
https://xtalks.com/webinars/enzyme-therapy-manufacturing-preserving-activity-through-production/
