EHS and Biosafety Archives

The 13-step guide for conducting cell and gene therapy EHS risk assessments

Oct 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, EHS and Biosafety, Publication

This article and template summarize the main steps in a suggested EHS risk assessment process and can form the basis for discussions between a contract manufacturer and client or between production and development departments.

Adeno-associated virus (AAV) viral vector inactivation survey

Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, EHS

This member only survey looks to identify the current approaches used in inactivation of AAV viral vectors, the laboratory and large-scale manufacturing, by gathering information on inactivation alternatives to 10% bleach, known risks, issues or restrictions identified and supportive literature where available.

Single-use closed system failures

Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, EHS

A BioPhorum member only benchmarking survey to understand industry approaches to evaluating containment of single-use closed system failures resulting in spill, splash or aerosol release.

Risk assessment of cells used in early development

Sep 2021 | Cell & Gene Therapy, EHS, Publication, Raw materials

This paper is the first in a series considering real-world scenarios where the EHS companion risk assessment template has been completed. This assessment focuses on cell expansion operations working with the cell line only in R&D labs to develop procedures and controls; it does not include production operations, such as transfection or viral infections.

EHS and Biosafety

Viewing related articles

The 13-step guide for conducting cell and gene therapy EHS risk assessments

Adeno-associated virus (AAV) viral vector inactivation survey

Single-use closed system failures

Risk assessment of cells used in early development

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