CGT considerations within product transfer and validation

The process of transferring a product from a developer to a contract development and manufacturing organization and executing a successful validation campaign is a well-established process. However, due to numerous unique aspects required for a cell and gene therapy (CGT) product manufacture, there are a variety of unique or different considerations required during a transfer and validation campaign within CGT. Therefore, although transferring a product is ‘routine’, there is a risk that these CGT considerations are overlooked if treated as a ‘normal’ process.In this podcast we talk to Senthil Ramaswamy, Director of Cell and Gene Technologies R&D at Lonza; and Iara Cruz, Cell & Gene Therapy Site Manager at Roche, two of the authors from BioPhorum’s Cell & Gene Therapy Validation Workstream who contributed to the article CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization detailing these unique considerations within a CGT product transfer and validation; to gain an insight into the activity leading to the publication and what they see as the benefit of this work.