Enzyme Therapy Manufacturing:
Preserving Activity Through Production
About this webinar
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
- 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
- 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
Featured Speakers
Dave Briggs, PhD
Dave Briggs, PhD, brings extensive experience in biopharmaceutical manufacturing, spanning purification R&D, downstream process development, manufacturing operations, process validation and continued process verification. Throughout his career, he has supported the development, transfer, validation and commercialization of biologic processes, with a focus on translating scientific understanding into robust, scalable and compliant manufacturing solutions.
As a Principal Scientist in Manufacturing Science and Technology (MSAT), Late Stage/Commercial, at Avid Bioservices, Dave leads cross-functional initiatives supporting process performance qualification, lifecycle management, process monitoring and continuous improvement of commercial manufacturing processes. He is recognized for applying data-driven approaches to enhance process robustness, ensure regulatory compliance and drive operational excellence across the product lifecycle.
Dave holds a PhD in Molecular and Cellular Biology from the University of Arizona and a BSc in Microbiology from Brigham Young University. His expertise spans downstream processing, chromatography, technology transfer, process validation, manufacturing science and continued process verification, with a passion for transforming complex technical challenges into practical solutions that enable reliable and efficient biologics manufacturing.
Partner for this event
Avid Bioservices
Avid Bioservices is a leading U.S.-based mammalian cell culture contract development and manufacturing organization providing integrated process development, analytical development, and CGMP biologics manufacturing from DNA to IND to commercial supply.
A trusted partner for biopharmaceutical innovators worldwide, Avid combines manufacturing, operational discipline, and a transparent partnership model to reduce risk and simplify execution. Agility, quality, proven ability to navigate complex global regulatory landscapes and a steadfast FDA record make Avid the best choice for a U.S.-based biologics CDMO. From DNA to IND to Commercial, Avid is the U.S.-based biologics CDMO partner for every stage. With you, every molecule of the way.