Contamination Control Challenges Facing Cell Therapy Facilities

The presentation aims to provide an overview of challenges that can be faced with the knowledge that a one size fits all approach cannot be taken. While individual challenges may not be unique to cell therapies. They way they can impact cell therapy facilities can be unique with additional considerations given the nature of cell therapy products and production methods. Each process and facility is unique with some processes far removed from a traditional biologics facility and others that may be closely aligned with traditional production methods. Challenges outlined in the presentation related to some aspects that are related to process and materials that can be presented during cell therapy manufacturing. These include: Shelf life considerations for starting materials and finished product Contamination Control Schemes for Facilities and it’s importance in facilities. Control of personnel and the “human aspect” of cleanroom control. Manual nature of cell therapy production. Risk Reduction measures. Criticality of right first time Benefits and Drawbacks of isolator Technology.