Virelion Biotech — Biosafety Level Assessment

VIRELION BIOTECH

Biosafety Level Assessment Tool

This tool generates a general planning reference drawn from publicly available CDC/NIH (BMBL, 6th ed.; NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules) and WHO (Laboratory Biosafety Manual, 4th ed.) guidance. It does not replace formal review, protocol registration, or sign-off by Virelion's Institutional Biosafety Committee (IBC) and Biosafety Officer. Final BSL determination is an institutional decision.

Cell typeWhat is the base material being cultured?

iPSCInduced pluripotent stem cell line

ESC-derived CMEmbryonic stem cell–derived cardiomyocyte

Primary cellsDirectly isolated human/animal tissue

NHP primary cellsNon-human primate tissue / cells

Known BBP-positiveMaterial known/suspected to contain bloodborne pathogens

Genetic modificationHow is the genome or expression state altered, if at all?

NoneUnmodified line

TransientPlasmid, mRNA, or RNP transfection

Stable integrationGenome-integrated construct or reporter

Oncogenic / transforming insertKnown oncogene, toxin, or transforming gene product

Viral vector(s) usedSelect the delivery system, if any

NoneNo viral delivery system

AAVAdeno-associated virus

LentivirusTypically 2nd/3rd-gen, SIN

Lentivirus — high-titer productionLarge-scale or concentrated high-titer prep

RetrovirusGammaretroviral vector

AdenovirusE1-deleted, replication-defective

RCV / unknown competenceReplication-competent or untested for competence

Other / unsureRequires IBC vector-specific review

ScaleWorking volume for the largest single step

Bench< 10 mL

Small scale10–100 mL

Production / bioreactor> 100 mL or closed bioreactor

Intended useDownstream purpose of this work

Basic researchIn-house, non-GLP

PreclinicalGLP-adjacent studies

Therapeutic manufacturingGMP-track, clinical intent

In vivo animal workVector or cell delivery into live animals

Additional risk factorsSelect the highest applicable factor, or none

NoneNo additional escalators

Aerosol outside BSCAerosol-generating steps not fully contained in a BSC

High sharps / injection riskFrequent needles, catheters, or surgical delivery

RG3 / high-consequence agentRisk Group 3 organism or equivalent work

RG4 / maximum containmentRisk Group 4 or select-agent maximum-containment work

Suggested containment

—

Complete the form to generate a suggestion.

AWAITING INPUT

Engineering controls & PPE

Waste handling

Training

Documentation

SOURCES: CDC/NIH BMBL 6th ed. · NIH Guidelines for rDNA Research · WHO Laboratory Biosafety Manual 4th ed. · General reference only — confirm with Virelion EHS/IBC.