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AI agent for biologists

Probiotic Strain Viability and Label Claim Agent

A projected end-of-shelf-life count with trusted data, and a plan if the label claim is at risk

AnalysisRisk managementForecastingScience and research
See how it worksGet access
Probiotic Strain Viability and Label Claim Agent: what goes in, what the agent does and what you get

What it does

Probiotic products are labeled with a count that must still be true at the end of shelf life, and counts fall over time. This agent tracks plate counts across each stability time point, fits the decline, and projects the count at the end of the claimed shelf life. Before trusting a number, it checks plating controls, dilution consistency and replicate spread, because a bad plate can fake a drop. If the projection falls below the label claim, it flags the risk and proposes an overage or a process fix, such as a different packaging or storage condition, and reruns the projection. The lead approves any label or formulation change. Edge case: one time point has a count 10 times lower than its neighbors, so the agent requests a repeat before fitting.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
Yes, continueYes, continueApprovedNoNo 1 STARTS WHEN New stability counts arrive 2 USES A TOOL Read counts, controls and dilution records 3 CHECKS THE RESULT Do controls pass and replicates agree within theallowed spread? If not: mark the time point as questionable and requesta repeat plating. Back to step 2. 4 DOES Fit the decline over time for each lot 5 DOES Project the count at the end of shelf life 6 CHECKS THE RESULT Is the lower bound of the projection above the labelclaim? If not: calculate the overage or process change neededand rerun. Back to step 4. 7 DOES Compare lots and storage conditions 8 DOES Draft the risk summary with options 9 YOU APPROVE Lead approves any label or formulation change 10 RESULT Stability projection report
Read the steps as a list
  1. New stability counts arrive
  2. Read counts, controls and dilution records
  3. Do controls pass and replicates agree within the allowed spread?If not: mark the time point as questionable and request a repeat plating. Back to step 2.
  4. Fit the decline over time for each lot
  5. Project the count at the end of shelf life
  6. Is the lower bound of the projection above the label claim?If not: calculate the overage or process change needed and rerun. Back to step 4.
  7. Compare lots and storage conditions
  8. Draft the risk summary with options
  9. Lead approves any label or formulation changeThe agent waits here for your OK.
  10. Stability projection report

How it decides

A time point enters the fit only when controls pass and replicates agree. The projection uses the lower confidence bound against the claim.

  • Exclude a time point when controls fail
  • Require replicates within 0.3 log of each other
  • Use the lower 95% bound for the projection
  • Propose overage only when the projection falls within 0.5 log of the claim

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Replicate spread limit (default 0.3 log)
  • Confidence level
  • Shelf life and claim
  • Storage conditions

What keeps you in control

It always asks you first

  • Label claim or formulation change
  • Any release decision on a lot

Hard limits

  • Never changes a label claim
  • Never discards data without a recorded reason

It stops when

  • Done: projection supports the claim or a plan is approved
  • Stop: too few time points to fit

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensLot 7 started at 2.1 billion CFU per capsule with a 1 billion label claim at 24 months. The 9 month count was 10 times lower than neighbors and the control plate failed, so the control check failed. The agent requested a repeat, which returned 1.7 billion. The fit projected 0.9 billion at 24 months, below the claim, so it proposed a 25 percent overage. The lead approved it.

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