Facilities for the future: design & qualification of aseptic manufacturing facilities for cell and gene therapy

Optimally designed facilities are key to ensure that products can be manufactured to the highest standards of quality, safety and efficacy in accordance with the appropriate regulatory requirements. In this commentary we describe the experience of our organization over the last decade where we have designed, commissioned and qualified three manufacturing facilities during a period where regulatory expectations, together with the range and complexity of advanced therapeutics has increased exponentially. The aim of this article is to provide high-level guidance to those in the field as to how undertake such a task, particularly given the lack of guidance available for cell and gene product manufacture.

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