20 Questions That Separate an Exosome Manufacturer from a Repackager

The pilot deposit is where exosome brand owners lose money. The questions that separate a real manufacturer from a repackager only occur to you in hindsight — so here they are in advance. Here they are in advance — twenty questions in four stages, ordered so each stage's answers decide whether the next stage is worth your time.

Stage 1 · Documentation (the disqualifiers)

1. Can you send a sample COA before I commit — with batch ID, methods and release limits printed?
2. Which measurement guideline does your release panel follow?
3. Is your characterization logic aligned to MISEV2018, and can you show how?
4. Do you keep retain samples per batch, and for how long?
5. Which filings cover the material line — INCI, DMF Type II, or the market equivalent?

Repackagers stall here. They sell programs; they cannot produce the material's paper trail.

Stage 2 · Manufacturing (the reality check)

1. Is your line fully enclosed — culture to fill without open handling?
2. What is your recovery rate, and which method measured it?
3. How do you score and select seeds — what fraction of candidates survive screening?
4. What is your batch scale (0.5–5 L, or campaign volume)?
5. How long does a format changeover take — and does it re-require validation?

Stage 3 · Compliance (the legal perimeter)

1. Which market frameworks do you ship under — EU 1223/2009/CPNP, US MoCRA, DSHEA?
2. Where do your claims stop — show me your wording discipline on a finished label.
3. Who is your Responsible Person / US agent for destination markets?
4. What documentation pack ships with each order — COA, characterization summary, lane records?
5. Have you had a claim challenged, and what happened?

Stage 4 · Logistics & program (the relationship)

1. What are your cold-chain lanes — temperatures, windows, logging?
2. What is your pilot MOQ, and does the pilot run on the production line?
3. What is your standard and rush lead time by batch tier?
4. Can I speak to a reference program — a clinic or channel running your product?
5. What happens when a batch fails — re-run, refund, or silence?

Scoring: a real manufacturer answers 16+ of 20 in the first exchange — most of it with documents rather than prose. A repackager answers 5. The same twenty questions are our documentation chain in question form. Run them against us, or start with the COA reading guide.