Ensuring quality in cell and gene therapy: Dave Lewandowski

How can manufacturers address the challenge of ensuring quality standards are met during scale-up? We spoke to Dave Lewandowski, Director, Business Development, CGT, Azenta Life Sciences (MA, USA), at the International Society of Cell & Gene Therapy 2022 Annual Meeting. Dave discusses what he’s learned over his varied career and considerations for developers looking to ensure quality and consistency from sample collection, storage, product manufacture and, eventually, delivery.

Dave previously worked at Brooks Life Sciences (MA, USA), where he visited leading research, manufacturing and patient care facilities who require cryogenic infrastructure to support their efforts. He has served as President for the International Society of Biological and Environmental Repositories (ISBER.org). As President, he initiated an effort with the Society of Cryobiology to create and publish the first Liquid Nitrogen-Based Storage Facility Best Practices. This consensus document includes contributions from over 20 experts with a broad range of expertise. David enjoys working with managers in supply chain, operations, facilities, QA/QC and others to define systems which are adaptable, scalable and repeatable.

Sarah Rehman

Sarah is the editor of RegMedNet and author of this article. She ensures that the site is up-to-date with the latest news and views in the field of regenerative medicine, from breakthrough therapies to industry collaborations. With a background in both Zoology and Ecology, she has a particular interest in the environmental impact of the industry and the innovations that could move us towards a sustainable future.