Running since September 2018, the EHS and BioSafety Workstream has representatives from 15 member companies. The 23 subject matter experts (SMEs) work closely together and represent multiple areas of the business (autologous and allogenic cell therapy and gene therapy, viral vector bulk manufacture, and plasmid design).

The initial focus of this team has been operator safety during commercial-scale manufacture. This focus was chosen as our member companies are moving at speed towards manufacture of a range of cell and gene therapy (CGT) products. The team has spent time to draw together their experience and learning, to write a paper for publication by the Journal of Applied BioSafety.

It is hoped that the paper due to be published soon, titled Environmental health and biosafety risk assessment framework for commercial scale cell and gene therapy manufacturing, will provide clarity and focus within the CGT industry. The paper is aimed at the EHS specialist who is reviewing or establishing a CGT manufacturing facility. The reader is walked in detail through the creation of a risk assessment, covering methodically the topics of process materials (including reagents and vectors), process operations and controls, facilities (including utilities and equipment), employee training, existing site systems or policies, and storage. The paper includes a risk assessment template, which will be of practical assistance to the reader as they consider the risk factors for their own processes.

 

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