cGMP manufacturing made easy – a case study by ElevateBio

It’s an exciting time for cell and gene therapy companies looking to support clinical trials or commercial production. To deliver on the promise of their therapies, these companies must address some key industry hurdles — process development, training, rapid translation to cGMP, and capacity expansion. They need to quickly learn to navigate the dynamic landscape. And they must choose a solution that’s scalable, functionally closed, and flexible to support their needs, both today and in the future.

In this webinar, ElevateBio will discuss how they built a team and technology infrastructure at their BaseCamp innovation center to support development and manufacturing for cell and gene therapy companies with a wide range of requirements. They’ll talk about why they chose Cytiva’s FlexFactory™ solution to help scale, close, and automate their manufacturing workflow. And they’ll describe how Cytiva’s Chronicle™ Automation Software was integrated with their existing digital infrastructure. This step was key, as it allows them to improve the consistency of their processes and enabled them to leverage automation and analytics to further refine and optimize processes.

Finally, ElevateBio will discuss opportunities to collaborate, share the lessons they learned, and offer guidance to other companies facing similar challenges with scale-up and translation to cGMP.

• Understand the significance of closed and automated equipment platforms.
• Learn more about Cytiva’s FlexFactory™ solutions to address capacity expansion issues.
• Discuss how Chronicle automation software™ can help monitor equipment, streamline processes and increase regulatory compliance, etc.
• Discover lessons learned and guidance for expansion capacity projects.

Michael Paglia

COO, ElevateBio, BaseCamp

Michael has spent the last eighteen years in biotechnology building, leading and motivating process development and manufacturing teams to support clinical programs from early development to late stage clinical trials. Michael has been responsible for cellular and viral process development and analytics, cGMP manufacturing operations, CMC regulatory strategy, cellular procurement, and process characterization and validation activities for multiple novel cell and gene therapy products. Currently, Michael is the Chief Operating Officer at ElevateBio, BaseCamp leading the operations for a broad portfolio of cell and cell therapy products and technologies. Prior to ElevateBio, Michael was the Vice President of CMC operations at Oncorus working on the development of a next-generation oncolytic immunotherapy platform to treat cancer and bluebird bio as the Head of Technical Operations and Cellular Process Development and Manufacturing Operations for all lentiviral vector-based autologous hematopoietic stem cell and CAR T cell programs.

Shannon Eaker

Cell and Gene Therapy Enterprise Solutions and FastTrak Leader, Cytiva

Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T-cell, HSC, and ES/iPSC cell biology, and has been with Cytiva (formerly GE Healthcare) Cell and Gene Therapy for over 11 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently Cytiva's Cell and Gene Therapy Enterprise Solutions and FastTrak Leader. Shannon lives with his wife and 2 kids in Knoxville, TN.