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

Among the many hurdles for cell and gene therapies (CGT) 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 CGT manufacturing processes.

This is why BioPhorum’s paper, Environmental Health and Biosafety Risk Assessment Framework for Commercial Scale Cell and Gene Therapy Manufacturing,is so important to this growing part of the industry, especially for environmental health and safety (EHS) and biosafety professionals.

The paper published in the Journal of Applied BioSafety will be useful for those working in this area because it identifies, shares and enhances best practices and standards, improves risk controls and increases the speed of learning. Ultimately, it will help regulatory agencies when developing guidance or policies around CGT development and manufacturing.

The paper 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?

The risks associated with commercial-scale CGT manufacture are not yet fully known and industry is building a body of knowledge of the hazards to operators. Understandably, industry lacks experience in these novel therapies and there is also no standardized CGT process – so this framework brings a more strategic than specific approach to assessing risks.

There are many issues facing organizations moving into the field of CGT manufacture, which are further complicated when trying to do this on a commercial scale. BioPhorum’s framework will help EHS and biosafety professionals use a best practice approach to assessing risks around these novel therapies.

Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing