Sitero helps cell and gene therapy (CGT) teams translate complex biosafety requirements into clear, defensible decisions across research, manufacturing, and clinical operations.
From viral vector risk assessments to IBC support, training, and readiness planning, Sitero helps reduce friction without over-promising regulatory outcomes.
Sitero provides advisory and consulting services to help clients prepare for biosafety reviews and inspections, but institutional IBCs, IRBs, and regulators retain full control over timelines and decisions.
The role of the biosafety team is to support reasonable, defensible biosafety positions aligned with current guidance, not to guarantee specific regulatory or committee outcomes.
Where CGT Biosafety Gets Complicated
CGT programs often face biosafety challenges that surface late, including unclear NIH Guideline applicability, inconsistent containment decisions, gaps between R&D and scale-up, and training issues that emerge during inspections.
Sitero helps teams identify these risks early and build practical biosafety approaches that can stand up to internal review, committee scrutiny, and operational reality.
How We Support CGT Programs
Why Organizations Engage Sitero
The Sitero Difference
Sitero pairs advanced cell and gene therapy biosafety expertise with Mentor eCompliance technology to support clearer, more scalable IBC oversight. The result is a more connected approach to biosafety documentation, workflow, and compliance visibility across complex CGT programs.
Sitero’s biosafety support is built around decisions that are technically sound and practical to implement.
De‑Risking Cell & Gene Therapy Biosafety: From Lab Bench to First Patient In
Check out our “De‑Risking Cell & Gene Therapy Biosafety: From Lab Bench to First Patient In” infographic for a clear, visual walkthrough of the key checkpoints and biosafety decision points that most often drive late surprises in CGT programs. It’s a simple way to help internal stakeholders see where NIH Guideline interpretation, containment choices, and training can either support, or slow down, your next milestone.
