Cryostorage in cell and gene therapy is often treated as a downstream freezer or logistics decision. In reality, it is a critical GMP unit operation encompassing cryopreservation, storage, and controlled handling that directly impacts product quality, cell viability, operator safety, data integrity, facility design, automation strategy, and long-term commercial scalability.
This webinar reframes cryostorage as an engineered system that must be designed early - not retrofitted later. Drawing on real-world experience from commercial manufacturers, process development teams, facility engineers, and cryostorage platform owners, speakers will examine how early decisions around cryopreservation workflows, automation, and storage architecture influence comparability, inspection readiness, tech transfer, and global supply chain resilience.
Through case-based discussion, attendees will learn how thoughtful cryostorage, engineering and automation choices can reduce operational risk, preserve product quality, avoid costly facility modifications, and support a smooth transition from clinical to commercial manufacturing.
The session will conclude with a live audience Q&A, giving participants the opportunity to engage directly with the speakers and explore challenges specific to their own cryostorage and manufacturing environments.
Attend this webinar to:
- Understand why cryostorage should be treated as core GMP unit operations - not downstream storage or logistics functions
- Learn how early cryogenic decisions influence cell viability, product quality, chain of identity/custody, inspection readiness, and commercial scalability
- Explore engineering and facility design considerations supporting automated cryogenic workflows, including automation strategy, ODH mitigation, redundancy, access control, and data integrity
- Gain real-world insight into transitioning from manual, operator-dependent cryogenic handling to automated cryostorage, including operational, quality, and change-management lessons from GMP environments
- Apply a cross-functional framework to align Manufacturing, QC, MSAT, Engineering, and Supply Chain early - reducing late-stage change controls and compliance risk
Register now to see how treating cryostorage as a designed system, not a downstream freezer decision, can protect product quality, enable automation, and support global CGT scale-up.
Paola Terreni
Cell Process Development Manager at AGC Biologics
Paola Terreni is the Cell Process Manager at AGC Biologics’ Milan facility, with over decade of experience in cell and gene therapy process development and manufacturing. She holds an MSc in Industrial Biotechnology from the University of Milano-Bicocca, with an academic specialization in the remediation of soils contaminated by petroleum-derived compounds. Paola began her career as a Cell Laboratory Technician at Biorep Srl, a biotechnology CRO specializing in advanced cell-based research services, where she gained extensive hands-on experience in cellular assays and laboratory operations. She subsequently joined MolMed, where she further developed her expertise in cell therapy processes, progressing from technical roles into process-focused leadership. At AGC Biologics, Paola has led process development and manufacturing activities for the past three years, supporting clinical and commercial cell and gene therapy programs. She has contributed to programs within a site with exceptional success track supporting more than 10 FDA- and EMA-approved products, with experience spanning technology transfer, GMP manufacturing, process optimization, and cross-functional collaboration. Her background combines strong technical depth with operational leadership, supporting robust, compliant, and scalable manufacturing solutions for advanced therapies.
Mudith Jayawardena
Associate Senior Scientist at Catapult CGT
Mudith is an Associate Senior Scientist at the Cell and Gene Therapy Catapult (CGTC), where he has spent more than nine years working in cell and gene therapy development primarily working with pluripotent stem cells (PSCs). As a subject matter expert in PSC biology, he supports the wider Cell Delivery programme, delivering projects in bioprocess development and scale up , differentiation, and cell engineering.His recent work has centred on optimising scaled end to end processes and integrating process analytical technologies (PAT) to improve efficiency. He also led the implementation of an automated cryostorage solution at CGTC’s London site, streamlining workflows and enhancing long term operational reliability.Mudith entered the cell and gene therapy field through his first role as an Assistant Editor at Bioinsights, which sparked his interest in the sector and set the foundation for his scientific career.
Peter Walters
Fellow of Advanced Therapies at CRB Group
Peter Walters is the Fellow of Advanced Therapies at CRB, with over 20 years of experience specializing in pharmaceutical process and facility design. He has a deep technical background in designing processes, equipment and spaces for multi-process facilities predicated on maximum flexibility, logistics optimization, and technologies that reduce costs while allowing pipeline expandability and higher-quality therapeutics. Working in process, equipment and facility design, he has gained a unique purview into aseptic equipment design and use, process scale up, pilot and GMP manufacturing operations. His expertise includes experimental design, process characterization, equipment and process troubleshooting, and manufacturing for clinical Phase 1 through commercial production. He has designed process facilities for monoclonal antibodies, gene therapies, cell therapies, aseptic novel processes, both in stainless steel and single-use. He helped author an NDA, has participated in FDA facility inspections, and is a patent awarded co-inventor of a novel process formulation method.
Scott Reeves
Director Applications Support at Azenta Life Sciences
Scott B. Reeves is the Director of Technical Sales & Field Applications Engineering at Azenta Life Sciences, where he leads a global team of Field Applications and Technical Sales Engineers focused on delivering tailored technical solutions that help accelerate scientific breakthroughs and the development of impactful therapies. He brings over 30 years of experience in the laboratory automation industry and has been with Azenta Life Sciences for nearly 25 years. Throughout his career, Scott has held a range of leadership and technical roles spanning Product Management, Technical Sales Engineering, and Operations, giving him broad expertise across the laboratory automation lifecycle. In addition to his industry role, Scott is an Executive Member of LRIG New England, a not-for-profit special interest group dedicated to advancing best practices, professional development, and innovation in laboratory automation within the life sciences community.Scott holds a Master of Science in Medical Physiology from Boston University School of Medicine and a Bachelor of Science in Biology from Boston College.
Olga Bukatova
Associate Director of Business Development for Cell and Gene Therapy at Azenta Life Sciences
Olga is Associate Director of Business Development for Cell and Gene Therapy at Azenta Life Sciences, with a strong background in GMP manufacturing technologies and cold chain workflows for advanced therapies. She has built her career at the intersection of manufacturing operations, cryogenic infrastructure, and supply chain strategy, supporting the delivery of cell and gene therapies from development through clinical and commercial stages.In parallel with her industry role, she serves as Co-Chair of the International Society for Cell & Gene Therapy (ISCT) Working Group on Cold Chain and Logistics, contributing to cross-industry efforts addressing the technical and operational challenges of advanced therapy supply chains.Olga holds a Master of Science in International Economics, with a focus on the pharmaceutical market. Her profile combines operational understanding with strategic engagement, supporting compliant, reliable, and scalable delivery of cell and gene therapies to patients.
