Project · Biomanufacturing
Eight kinds of evidence a company checks before it trusts a bio-made product, the four ReLeaf can put on its Biomanufacturing page this season, and a weekend plan for writing them.
The tag says what happens to each one on our page. Green goes on the page this weekend. Amber goes on as a declared gap. Grey belongs to another page and gets a link only.
Where each report sits
From the organism to the customer. A report describes one link; a reader checks the link they care about.
On the Biomanufacturing pageDeclared gapAnother page
Titer, rate and yield (TRY), run by run, plus how stable and repeatable the strain is. The first thing anyone asks.
On the pageHow the product gets out of the culture, and what fraction survives each step. Usually 50 to 80 percent of production cost.
On the pageCost per kilogram, its assumptions, and which input moves it most. Our rule: no cost figure until a bill of materials is in the repository.
Declared gap + BOMA spec sheet: each property, its limit, the test method and the batch results. The certificate of analysis a buyer receives.
On the pageHost safety status, containment, whether any live cells or DNA reach the product, and which law the product falls under.
On the pageDoes the product do its job in the field? For ReLeaf that is plant evidence, which the scope rule keeps on the Plants page.
Link to PlantsEnvironmental footprint against the incumbent, done to ISO 14040/44. Needs inventory data we do not have yet.
Not this seasonFreedom to operate, market, customers, manufacturing partner. Already handled on the Entrepreneurship page.
Link to EntrepreneurshipThe Biomanufacturing page already has a scaffold. Each report fills a section that exists, so nobody has to invent structure.
| Report | Page section it fills | What it must show |
|---|---|---|
| 01 Performance | The reactor as a characterised unit operation | Growth fit per run (linear and exponential, both shown), run length, n, operating mode A/B/C, cross-flow setting, which strain. |
| 02 Recovery | The reactor as a characterised unit operation → new sub-heading "Getting the product out" | Membrane spec, shell-side vs lumen-side signal from the Western, permeate flow, every recovery step with its loss. |
| 04 Quality | New short section "Product specification", placed after the reactor section | A spec table in the leghemoglobin style: property, limit, method, result, n. Identity (anti-His band size), activity, shell sterility. |
| 05 Biosafety | Making it where it is used | Shell-side plating results at every sample point, what the 0.2 µm pore does and does not hold back, and the regulatory route. |
| 03 TEA | Claim ledger, as one row marked "not yet established" | The BOM if it exists. If not, one sentence saying what the cost model would need. |
House rules still apply: a unit, a sample size and a source on every number; the limit in the same paragraph as the result; no verb that implies a measurement we did not make.
Two real products, chosen because each one is the best public example of one kind of report. Fifteen minutes each.
Yeast went from 0.1 to 25 g/L and a factory was built. Then the plant crop got cheap and the factory stopped. What a TRY report and a price sensitivity would have shown.
Read the case Case 2 · Reports 04 and 05A protein made in engineered yeast. The first FDA filing stalled over the host proteins nobody had characterised. The second came back with a spec table we can copy line by line.
Read the caseTwo people, two days. Everything is typed into the Bioreactor Report builder, which saves on your own computer and exports a PDF. The PDF becomes the source for the page text.