The T-cell therapy company has been tipped as a potential leader in a potentially disruptive field as new data support wide application in cancer.

Following protracted consultations with stakeholders on how best to specify good manufacturing practice standards for advanced therapies, the European Commission has at last published the long-awaited guideline. The industry is now keen to work with EU inspectors and competent authorities to develop a common understanding of the risk-based principles outlined in the final document.

The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.