An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet

细胞和基因治疗安全数据表的行业提案

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作者:Qirong Wu, Shana Elkind, Francine Preston, Michael Wachala, Erin Dunn, Sarah K White, Dirk Windhorst, Kimberly DiGiandomenico, Colin McGuire, Herbert Brok, Rachel Hodges1

Conclusions

This initial CGT SDS communicates workplace hazards and assesses the unique risks posed by these biological materials and can assist in creating exposure control plans specific to the workplace hazards.

Discussion

The CGT SDS provides industry with a best practice to address an existing gap in hazard communication for CGT. We expect that, as the field evolves, so may the contents. The CGT SDS can be used as a reference for other biological modalities in the field. Conclusions: This initial CGT SDS communicates workplace hazards and assesses the unique risks posed by these biological materials and can assist in creating exposure control plans specific to the workplace hazards.

Methods

Following the sections of a traditional chemical SDS, information was modified by industry subject matter experts, relevant to CGT biological materials. This guide was developed based on assumptions of a maximum biosafety level 2, and any chemical components present in the material were excluded from the hazard classification.

Results

The guide contains necessary information to conduct a workplace risk assessment and communicate the unique workplace hazards posed by potential exposures to the material. The target audience is intended to be entities handling and producing these materials, plus collaborators, contractors, or operations sites receiving and handling the CGT material. An example of a CGT SDS is provided in Table 1.

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