SOP · STRAIN ENGINEERING
Strain Design & Containment-Trial Protocol
ActiveStrain EngineeringRev B
Purpose
To govern the design, construction, and containment-trial of engineered agents against a control spec, with a mandatory paired countermeasure before any agent leaves the design stage.
Scope
All gain-of-function strains, gene drives, and engineered agents in development.
In scope:
Design spec, construction, containment trial, characterization.
Out of scope:
Stockpile control (PAN-SOP-0008); vault access (PAN-SOP-0005).
Definitions
Control spec
The transmissibility, lethality, latency, and evadability targets an agent is designed to.
Containment margin
The margin between an agent's controllability and uncontrolled escape.
Responsibilities
Strain Engineering Lead (Owner)
Owns the design spec and the countermeasure-pairing gate.
Bioengineer
Constructs and characterizes the agent under containment.
Director of R&D
Approves the design and the containment trial.
Procedure
Design & construct
- Specify the control spec and the paired countermeasure.
- Construct under containment from cryo-bank substrate.
- Verify sequence and function.
Trial & characterize
- Run the containment trial in the BSL-4 Vault.
- Score against transmissibility, lethality, evadability, margin.
- Stockpile only with the countermeasure filed.
PPE & Controls
Containment suitSealed lab workspace
Records Generated
- Design spec
- Construction log
- Characterization record
References
- Countermeasure Pairing
- BSL-4 Vault Access
- Cryo Subject-Line Handling
Revision History
| Rev | Date | Note |
|---|---|---|
| A | 2090-12-15 | Initial issue. |
| B | 2091-01-18 | Made countermeasure pairing a hard gate. |