Digital Batch Traceability — From Line Log to Vial Scan
Traceability claims are cheap; a resolvable vial history is not. This playbook is the system behind ours. parameters, batch records, and scan-to-document linkage make every vial's history a lookup.
01 · The problem
Most brands claim traceability; few can resolve one vial code end to end on request. This page shows ours. The claim without the system is marketing, and in professional channels it is a liability. Digital batch traceability means: culture parameters logged on the closed line, batch records generated at release, retain samples linked to batches, and a scan-to-document layer that resolves a vial code to its full chain.
02 · Scientific rationale
The closed line is the traceability advantage: culture and processing parameters are logged inside the sealed system (no open handling means no record gaps), batch records generate at release with the QC panel attached, and retain samples link physical material to records. The digital layer resolves formats (vial, tablet, mist) back to their material batches — program families trace to one baseline.
03 · Program documentation
Each layer above is specified in TONGNIAN's internal quality-system documentation [6]; partners can review the full protocol set under NDA.
Method anchors: [1] EV biology and cargo [2] MISEV2018 characterization [3] category evidence (review or registered study) [4] formulation and handling guidance [5] national measurement guideline (2026 No. 17) [6] internal protocol and case documentation.
04 · Product architecture
| Layer | Record | Serves |
|---|---|---|
| Line logging | Culture + process parameters | Production integrity |
| Batch records | QC panel + release | Channel and audit |
| Retain linkage | Physical sample ↔ record | Dispute and recall |
| Scan layer | Vial code → full chain | The buyer-facing lookup |
05 · Process & QC
Records generate at each stage and link at release; the scan layer resolves program formats to material batches. QC per the standard panel [2][5].
Fig. 1 — The traceability chain: line logging to scan lookup.
06 · Regulatory pathway: EU & US first
Traceability records serve EU (PIF support), US (MoCRA listing support), and professional-channel documentation simultaneously.
07 · Expected outcomes
- One-lookup history: scan a vial code and the full chain comes back, culture log to release record.
- Audit-native: batch records already exist when an audit or distributor asks; nothing is reconstructed afterward.
- Professional-channel ready: this is the documentation layer clinics and vets request first.
No claims beyond the destination-market framing — authority comes from documentation and batch measurement.
08 · Commercial framework
Sample kits in 3-5 days; pilot from 500 units; production from 2,000 units; standard lead 15 workdays - all indicative, quoted per request. White-label and program naming run through the OBM program.
Request a quote - Line fact-sheet per program page.
References
- Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020;367(6478):eaau6977.
- Théry C, et al. MISEV2018. J Extracell Vesicles. 2018;7(1):1535750.
- Cobetter. Exosomes Part I: Applications and Downstream Processing Overview. Technical review, 2025.
- Guideline for Exosome Particle Size and Concentration Measurement (2026 No. 17) — TONGNIAN, drafting organization.
- TONGNIAN internal process documentation — closed-line SOPs, QC panels, batch records (partner access under NDA).
Apply this playbook to your category
Submit your brand stage, target category, and target volume tier to receive specifications, MOQ, and lead-time quotes for the matching tier (quotation follows the tier structure).