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CGT safety data sheet template

1 September 2023
Advanced Therapy Medicinal Products
CGT safety data sheet template
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122 downloads

A safety data sheet (SDS) is an established hazard communication tool for the chemical industry, for which no comparable document exists in the biotherapeutics industry. As the cell and gene therapy (CGT) field expands, industry leaders have identified a growing need to address this gap in communication around the unique occupational health and safety risks posed by CGT materials and products.

Published in the Journal of Applied Biosafety, this guide and supporting template contains the necessary information to conduct a workplace risk assessment and communicate the unique hazards posed by potential exposures to CGT materials.

Based on the sections of a traditional chemical SDS, the information was modified by experts in CGT biological materials. Our guide contains 16 narrative sections ranging from hazard identification and composition/information on ingredients, to disposal considerations and transport information. There is also a downloadable template that you can use to communicate workplace hazards and assess the risks posed by CGT materials.

This guide and supporting template was developed based on assumptions of a maximum biosafety containment level 2 and any chemical components present in the material were excluded from the hazard classification.

It is aimed at those handling and producing these materials, as well as collaborators, contractors, or operations sites receiving and handling the CGT material. However, it may also be helpful as a reference for other biotherapeutic modalities such as protein therapies, mRNA, and plasmids.

This initial CGT SDS communicates workplace hazards, assesses the unique risks posed by these biological materials, and can help you create exposure control plans specific to CGT workplace hazards.

Please view the full paper at Journal of Applied Biosafety  and direct questions to BioPhorum at info@biophorum.com.

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