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

Area of Science:

• Biotechnology
• Occupational Health and Safety

Background:

• The biotherapeutics industry lacks a standardized hazard communication tool comparable to chemical safety data sheets (SDS).
• The expanding cell and gene therapy (CGT) field necessitates addressing unique occupational health and safety risks associated with CGT materials.

Purpose of the Study:

• To develop a novel safety data sheet (SDS) guide tailored for cell and gene therapy (CGT) materials.
• To bridge the existing gap in hazard communication for CGT products and materials.

Main Methods:

• Adapted traditional chemical SDS sections for CGT biological materials.
• Industry experts modified content based on maximum biosafety level 2 assumptions, excluding chemical components from hazard classification.

Main Results:

• A guide was developed containing information for workplace risk assessments and communication of CGT material hazards.
• The guide targets entities handling, producing, or receiving CGT materials, including collaborators and contractors.
• An example of a CGT SDS is provided.

Conclusions:

• The CGT SDS offers a best practice for hazard communication in the CGT industry.
• This standardized approach can assist in creating workplace-specific exposure control plans.
• The CGT SDS can serve as a reference for other biological modalities.