Precision BioSciences Deploys Skyland PIMS in Support of Its Manufacturing Operations

Key points:

• Precision BioSciences deploys Skyland PIMS to support its manufacturing operations
• The Company was looking to move away from manual workflows including recording and transcribing batch data into Excel
• PIMS’ value is the data repository, streamlined batch review and verification, and knowing what data can be trusted

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.

Operational needs

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 emailed 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.

Evaluation process

The Company’s manufacturing team is experienced with enterprise batch data management and quality assurance, which led them to seek a solution that is easy to implement, offered intuitive data entry and democratizes data so that all stakeholders have easy access. The Company formed a selection task force led by its Senior Manager of Manufacturing Sciences. Multiple enterprise batch data management products were evaluated using a structured process that scored candidates on eight weighted requirements. Based on this rigorous scoring methodology and following final approval from its executive team, the Company selected Skyland PIMS cloud-based process information management system.

Customer quotes

Process Engineer at Precision BioSciences

• Data verification has been streamlined with Skyland PIMS. We will see where the
  data is in the pipeline and who is up next so that QA no longer has to scramble before
  sending data to the FDA.
• Regarding Continued Process Verification, we plan to validate the software, and then
  there will be no more need to put batch data into our ELN. PIMS 21 CFR Part 11 does
  matter. PIMS will be part of our GMP (Good Manufacturing Practice). CPV is the goal.
• Our experience with Skyland has been very positive. They have been very helpful in
  understanding our needs and timeline and our unique situation. They’ve been great
  to work with across the board, especially on pricing and to understand the optimal
  licensing arrangement across our product portfolio.
• Top benefits of PIMS will be that we no longer have to rely on email and Excel, and we will have one source of verified data and nearly real-time access.
• PIMS’ value is the data repository, streamlined batch review and verification, and knowing what data can be trusted.

Why Skyland PIMS?

The following were reported as top value propositions:
• Repository – PIMS will be a single source of verified and trusted data.
• Transparency – Batch data verification stakeholders see where data is and who has the
next action.
• Price – PIMS pricing was attractive vs. higher cost solutions.
• Partnership – Precision sees Skyland as a partner, willing to listen and be flexible.

Keys to success

The following were reported as important to selecting Skyland PIMS:

• Demo – Product demonstration was reported as key to stakeholder buy-in.
• IT – Important to involve IT as early as possible in the sales process

Expected benefits

Precision expects PIMS will provide the following:

• Excel – Eliminate manual batch data organization and analysis processes in Excel with use
  of PIMS’ import template for streamlined data collection and import.
• ELN – Once validated, PIMS will eliminate the need to store manufacturing batch data in the
  electronic lab notebook.
• CPV – PIMS will play a role in the company’s GMP and CPV strategy.