Case Study

Biotechnology Company Utilizes Process Data Management Software To Support Its Manufacturing Operations

Cell Gene Technology

Precision BioSciences (NASDAQ: DTIL) is a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies. With an eye towards therapeutic applications, the company’s ARCUS® genome editing platform has the potential to deliver safer, more specific genetic edits. ARCUS has a naturally occurring gene editing property that shuts itself off after making a highly specific DNA edit. This built-in safety switch is a key differentiator compared to other gene editing technologies. The company has about 225 employees.

Precision BioSciences produces multiple allogeneic CAR T products via in-house and contract manufacturing groups. Without automated data acquisition capabilities, batch data is manually recorded and transcribed into an Excel file, which is then e-mailed or shared on a network folder. Data is then verified and a PDF entered into the ELN for QA. All of this requires manual workflows.

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