EHS and BioSafety

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EHS: Environmental health and biosafety risk assessment framework for commercial scale cell and gene therapy manufacturing and template

This paper and supporting template identifies, shares and enhances best practices and standards, improves risk controls and increases the speed of learning. It discusses a general process designed to provide a risk assessment framework and contains a ready-to-use template. This highlights the complexity of commercial-scale manufacturing as well as considering the areas to assess, potential questions to ask while assessing them, and the other parties who may have pertinent input to the overall risk assessment.

The template can form the basis for discussions between a contract manufacturer and client, or between production and development departments. The aim is to address the following questions when evaluating the CGT manufacturing process: What could go wrong? What controls are in place and are they enough? What did we learn from this?

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How to assess EHS risks for commercial-scale CGT manufacture

The rapidly expanding field of cell and gene therapies (CGT) has the potential to revolutionize curative treatments. However, among the many hurdles ahead are that occupational health and safety guidelines for the manufacture of CGT products have been lacking and there is no clear framework for considering risks for operators when working at a commercial scale. The result is that there is no ‘universal’ biosafety risk assessment template for...

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BioPhorum CGT – delivering and shaping industry approaches

Cell and gene therapies (CGT) are changing the treatment landscape for many diseases and, with each new headline, patients are putting their hope in the promises that these novel therapies may bring. However, these new approaches come with many challenges that the industry needs to address – from delivery paradigms, to regulatory and supply chain issues. BioPhorum Cell and Gene Therapy has worked hard for two years and is beginning to deliver...

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CGT Environmental Health and Safety (EHS) and BioSafety workstream

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...

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