In many critical ways, the design of facilities for multiple cell therapy processes is unlike the design of conventional pharmaceutical facilities. This article surveys several of the key issues to consider when designing facilities capable of manufacturing multiple cell therapies, including regulatory definitions, product life cycles, processing systems, relevant cell therapy technologies and equipment, biosafety, cross contamination, facility automation, and layout options. A case study is used to illustrate flexible cell therapy facility design.
The field of cell and gene therapy has come quite a long way since Friedmann and Roblin authored the paper “Gene Therapy for Human Genetic Disease” in 1972. The first approved gene therapy clinical research took place in the US under the direction of William French Anderson at the National Institutes of Health (NIH) in 1990, and the field has only accelerated since. Through the 2000s and 2010s, numerous advances have been achieved in the treatment of cancers and other genetically driven diseases. Most recently, US FDA approval of cell therapies from Kite Pharma (YESCARTA) and Novartis (KYMRIAH) have shown the power of cell therapies to treat cancers. Reading through the history of cell and gene therapy in the context of manufacturing facility design, it becomes increasingly clear how important it is to understand what these therapies are and how they are defined. Common questions for those new to the field are: What are cell therapies? Why do people refer to cell and gene therapies together? The answers are everyone’s least favorite response, “Well, it depends!” In this case, it depends on who you are asking.
Read the full article from ISPE's Pharmaceutical Engineering by clicking here.