Cell and Gene Therapy

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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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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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Mapping cell and gene therapy manufacturing

Cell and gene therapy (CGT) is a diverse field, with products and processes as varied as the patients it is trying to treat. As a relatively new group, the Commercialization Workstream in the CGT Phorum began by creating maps of the manufacturing processes for CGT; and what originally started as an internal exercise has grown into a valuable project that could benefit not only member companies but the industry as a whole. Creating the maps...

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IT for Cell and Gene Therapy

In 2020 only a few cell and gene therapies (CGT) are approved for commercial use, but hundreds of clinical trials are underway, and demand for manufacturing capability is set to grow. However the manufacturing equipment platform and associated digital capabilities are early in their maturity life cycle, in contrast to the established equipment platforms and digital capabilities for small molecule and biologics manufacturing. This is because...

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