Glossary
A glossary and FAQ library: Every term is one self-contained paragraph with complete references — written to be quoted verbatim. Drop the per-entry '(definition for reference, mock)' tags; state the standing disclaimer once in the footer: 'Definitions are educational references and make no efficacy claims.'.
Glossary · 20 terms, core concepts to process. First published set.
From core concepts to formats and process
Terms are grouped from core concepts → testing methods → commercial & compliance → formats & process, each as a self-contained definition paragraph (roughly 50–80 words) with one further-reading link. Definitions are for industry learning and reference alignment, and make no efficacy claims.
03 · Business & compliance
Characterization baseline
A characterization baseline is the fixed set of measurements (size, concentration, markers, safety panel) that every batch of a program is tested against. When all formats of a line share one baseline, siblings can be compared, mixed and extended without re-development — the property that makes program families coherent. (definition for reference)
01 · Core concepts
Conditioned medium
Conditioned medium is the cell-culture fluid collected after cells have grown in it — containing exosomes but also free proteins, growth factors and other components. Selling conditioned medium as exosomes is a known category shortcut: without isolation and characterization, a particle count cannot tell you what you actually received. (definition for reference)
03 · Business & compliance
CPNP notification
CPNP is the EU Cosmetic Products Notification Portal: every cosmetic product must be notified through it before being placed on the EU market, alongside a Product Information File and a designated Responsible Person under Regulation 1223/2009. First notifications typically take weeks; the sequencing rule is the PIF first, then the notification. (definition for reference)
01 · Core concepts
Endotoxin Test
An endotoxin test quantifies lipopolysaccharide (LPS) from Gram-negative bacterial cell walls, typically by gel clot (LAL) or kinetic chromogenic methods. Endotoxin limits are a key safety item in batch release for exosome products. When reading a COA, confirm the method, the basis for the limit and the reporting unit (e.g., EU/mL). Acceptable limits vary by application track and jurisdiction and are governed by the technical documents confirmed by both parties.
01 · Core concepts
EV (Extracellular Vesicles)
Extracellular vesicles (EVs) are the umbrella term for all membrane-bound particles released by cells, grouped by biogenesis and size into exosomes, microvesicles and other subtypes. EV is the more neutral term in industry and literature: subtypes coexist in any sample and cannot be fully separated, so standards typically define characterization and testing against EV as a whole. When evaluating EV products, focus on source cell, characterization data and batch consistency rather than a vague "vesicle content" claim.
01 · Core concepts
Exosome
Exosomes are nanoscale (30–150 nm) extracellular vesicles released when intracellular multivesicular bodies fuse with the cell membrane, naturally carrying proteins, lipids and nucleic acids as cargo. In industry usage "exosome" is often applied broadly to extracellular vesicle products; strictly, the term should be paired with a size range, source cell and characterization method to avoid confusion with larger vesicle subtypes.
01 · Core concepts
FDA DMF (Drug Master File)
A Drug Master File (DMF) is a US FDA filing regime under which an ingredient supplier confidentially submits manufacturing and quality-control information; once assigned a DMF number, the holder can authorize downstream customers to reference it in their own regulatory submissions. TONGNIAN holds FDA DMF 044197. For export-oriented brands, a DMF number is a key indicator of a supplier's documentation completeness and technical transparency, with citation governed by the filed documents.
01 · Core concepts
INCI (International Nomenclature of Cosmetic Ingredients)
The International Nomenclature of Cosmetic Ingredients (INCI) is the ingredient naming system used across the personal-care industry; skincare labels must declare ingredient names in INCI terms so products can be identified and checked across markets. TONGNIAN's plant-derived exosome materials are filed under INCI 41316; brands selecting EV ingredients for cosmetic tracks can use the INCI name for compliant labeling and supply-chain traceability in the ingredient list.
01 · Core concepts
Lyophilized Powder
A lyophilized powder is a solid dosage form made by freeze-drying a liquid active to remove water, offering better stability and shipping convenience than liquid formats and reconstituted with a paired solvent before use. For EV products, the lyophilization process must balance cryoprotectant formulation with post-reconstitution characterization consistency, and appears in formats such as solid serums and sheet masks. When evaluating lyophilized EV products, review the pre- and post-reconstitution particle size and activity data.
02 · Test methods
Marker proteins (CD9, ALIX)
CD9, CD63, CD81 and ALIX are proteins enriched in exosome membranes, and detecting them (commonly by western blot or flow assays) is the standard identity check that vesicles are exosome-like rather than other debris. A marker panel alongside NTA and TEM forms the minimum credible characterization triangle. (definition for reference)
01 · Core concepts
Micro-batch Production
Micro-batch production organizes manufacturing at 0.5–5L per batch (reference: fully closed micro-batch scale), completed in a fully closed environment from prototyping through commercial ramp-up, emphasizing batch flexibility, process traceability and rapid changeover. Compared with scaling directly to thousand-liter lines, micro-batch suits parallel validation across multiple categories and tracks and regionalized delivery; TONGNIAN's Mother Machine platform is designed to this reference.
03 · Business & compliance
MoCRA
MoCRA — the US Modernization of Cosmetics Regulation Act, 2022 — requires cosmetic facility registration (biennial), product listing (within 120 days, updated annually), adverse-event reporting and safety substantiation. The compliant marketing phrase is made in an FDA-registered facility; cosmetics are not FDA-approved. (definition for reference)
01 · Core concepts
MOQ (Minimum Order Quantity)
Minimum Order Quantity (MOQ) is the smallest quantity a supplier commits to for a single batch or order, usually tied to batch tiers (sample / 100-class / 1,000-class+). In exosome contract manufacturing, MOQ is driven by seed input, production scheduling and QC costs, and varies widely across product tracks. Aligning on batch tier and MOQ references before requesting a quote shortens the quotation cycle and helps plan inventory and channel pacing.
01 · Core concepts
NTA (Nanoparticle Tracking Analysis)
Nanoparticle Tracking Analysis (NTA) tracks the Brownian motion of individual particles via laser scattering and microscopy to derive particle size distribution and concentration; it is the primary technique for exosome size and concentration testing. When reading an NTA report, check three values: median particle size, particles per mL, and the dilution factor and loading volume. Results depend on sample preparation and instrument settings, so corroborate NTA with TEM morphology checks rather than reading it in isolation.
01 · Core concepts
Payload
Payload refers to the molecular cargo an extracellular vesicle carries — proteins, lipids and microRNAs. Payload checks on retained samples verify that processing preserved what the vesicles carry; a program without payload data is selling the envelope without proving the letter. (definition for reference)
03 · Business & compliance
Retain sample
A retain sample is a physical portion of a finished batch kept in storage after release, linked to the batch records. Retain samples make audits, disputes and re-testing possible months or years later — a COA without a retain-sample statement is a document without a backup. (definition for reference)
04 · Formats & process
Seed bank
A seed bank is a documented, cryopreserved library of cell lines from which production cultures are started. Source traceability, storage conditions and passage history in the bank are what make downstream batch comparability possible — batch consistency is decided upstream, at the seed. (definition for reference)
02 · Test methods
Size-exclusion chromatography (SEC)
Size-exclusion chromatography separates particles by size as they pass through a porous matrix: smaller proteins enter the pores and lag behind, while larger vesicles flow through first. Used after TFF as a polishing step, it removes residual proteins and aggregates and is a standard part of MISEV2018-aligned purification and characterization workflows. (definition for reference)
02 · Test methods
Tangential flow filtration (TFF)
Tangential flow filtration is a purification method where fluid flows parallel to the membrane surface, so captured material is swept away rather than clogging the filter. In exosome manufacturing it concentrates and washes vesicles gently — low shear protects the membrane, and dedicated cassettes with low protein adsorption support recovery above 95%. (definition for reference)
01 · Core concepts
TEM (Transmission Electron Microscopy)
Transmission Electron Microscopy (TEM) images ultra-thin samples with an electron beam, allowing direct inspection of vesicle morphology, size and impurities; it is one of the principal methods for morphological verification of exosomes. TEM captures the projected shape of dried, fixed specimens and therefore will not fully agree with NTA, which statistics particles in suspension. A sound test report states the reference and sampling conditions of both methods so the results can be cross-validated.
03 · Testing methods
NTA (Nanoparticle Tracking Analysis)
Nanoparticle Tracking Analysis (NTA) tracks the Brownian motion of individual particles via laser scattering and microscopy to derive particle size distribution and concentration; it is the primary technique for exosome size and concentration testing. When reading an NTA report, check three values: median particle size, particles per mL, and the dilution factor and loading volume. Results depend on sample preparation and instrument settings, so corroborate NTA with TEM morphology checks rather than reading it in isolation. (definition for reference)
04 · Testing methods
TEM (Transmission Electron Microscopy)
Transmission Electron Microscopy (TEM) images ultra-thin samples with an electron beam, allowing direct inspection of vesicle morphology, size and impurities; it is one of the principal methods for morphological verification of exosomes. TEM captures the projected shape of dried, fixed specimens and therefore will not fully agree with NTA, which statistics particles in suspension. A sound test report states the reference and sampling conditions of both methods so the results can be cross-validated. (definition for reference, mock)
05 · Testing methods
Endotoxin Test
An endotoxin test quantifies lipopolysaccharide (LPS) from Gram-negative bacterial cell walls, typically by gel clot (LAL) or kinetic chromogenic methods. Endotoxin limits are a key safety item in batch release for exosome products. When reading a COA, confirm the method, the basis for the limit and the reporting unit (e.g., EU/mL). Acceptable limits vary by application track and jurisdiction and are governed by the technical documents confirmed by both parties. (definition for reference, mock)
06 · Commercial & compliance
MOQ (Minimum Order Quantity)
Minimum Order Quantity (MOQ) is the smallest quantity a supplier commits to for a single batch or order, usually tied to batch tiers (sample / 100-class / 1,000-class+). In exosome contract manufacturing, MOQ is driven by seed input, production scheduling and QC costs, and varies widely across product tracks. Aligning on batch tier and MOQ references before requesting a quote shortens the quotation cycle and helps plan inventory and channel pacing. (definition for reference, mock)
07 · Commercial & compliance
INCI (International Nomenclature of Cosmetic Ingredients)
The International Nomenclature of Cosmetic Ingredients (INCI) is the ingredient naming system used across the personal-care industry; skincare labels must declare ingredient names in INCI terms so products can be identified and checked across markets. TONGNIAN's plant-derived exosome materials are filed under INCI 41316; brands selecting EV ingredients for cosmetic tracks can use the INCI name for compliant labeling and supply-chain traceability in the ingredient list. (definition for reference, mock)
08 · Commercial & compliance
FDA DMF (Drug Master File)
A Drug Master File (DMF) is a US FDA filing regime under which an ingredient supplier confidentially submits manufacturing and quality-control information; once assigned a DMF number, the holder can authorize downstream customers to reference it in their own regulatory submissions. TONGNIAN holds FDA DMF 044197. For export-oriented brands, a DMF number is a key indicator of a supplier's documentation completeness and technical transparency, with citation governed by the filed documents. (definition for reference, mock)
09 · Formats & process
Lyophilized Powder
A lyophilized powder is a solid dosage form made by freeze-drying a liquid active to remove water, offering better stability and shipping convenience than liquid formats and reconstituted with a paired solvent before use. For EV products, the lyophilization process must balance cryoprotectant formulation with post-reconstitution characterization consistency, and appears in formats such as solid serums and sheet masks. When evaluating lyophilized EV products, review the pre- and post-reconstitution particle size and activity data. (definition for reference, mock)
10 · Formats & process
Micro-batch Production
Micro-batch production organizes manufacturing at 0.5–5L per batch (reference: fully closed micro-batch scale), completed in a fully closed environment from prototyping through commercial ramp-up, emphasizing batch flexibility, process traceability and rapid changeover. Compared with scaling directly to thousand-liter lines, micro-batch suits parallel validation across multiple categories and tracks and regionalized delivery; TONGNIAN's Mother Machine platform is designed to this reference. (definition for reference, mock)
FAQ · Ten questions buyers ask
Ten questions about the glossary, terms and buying
Q1
Can I cite these definitions in brand materials?
Yes — cite them in the definition-paragraph format with attribution. Where specific product references are involved (specifications, limits, MOQ), the COA, filing certificates and mutually confirmed technical documents prevail; citing a definition makes no efficacy claim.
Q2
Why call this an AI-engine-friendly definition format?
Each entry is a single self-contained paragraph with an unambiguous term name, a one-sentence definition and reference notes. Those clear structural boundaries make it easy for search engines and AI engines to crawl, retrieve and quote the passage whole, reducing ambiguity and out-of-context excerpts.
Q3
Will the glossary keep growing?
Yes. Entries are updated as standards, filings and regulatory references evolve (the current 20 entries are the second batch), and new entries are added by group.
Q4
What particle concentration should my program use?
It depends on the program family and route: topical daily formats typically draw from the 5–20 billion particles/mL tiers, professional clinic material runs higher, and injection-track programs use the highest tiers under professional protocols. Dose follows a curve with an optimum — the tier is engineered with you at the brief stage.
Q5
How do I verify a COA is trustworthy?
Check five things: a resolvable batch ID, named measurement methods, printed release limits, a payload or purity figure, and a retain-sample statement. A COA missing any of these is a brochure. See the COA reading guide for the full walkthrough.
Q6
Are human-derived exosomes allowed in EU cosmetics?
Human-derived cells, tissues and products sit inside the restricted-substance framework of Regulation 1223/2009 — human-derived material is not a route for the EU shelf. Well-documented plant-derived and non-human material with INCI naming is the compliant path.
Q7
What does FDA registration actually mean for a supplier?
Under MoCRA, facilities are registered and products are listed — cosmetics are not FDA-approved. The compliant marketing phrase is made in an FDA-registered facility. Any supplier saying FDA-approved for a cosmetic is a claims risk to your shelf.
Q8
What recovery rate should an exosome purification line achieve?
Dedicated low-shear TFF with low-adsorption cassettes supports recovery above 95%. Recovery matters economically because purification is estimated at 40%+ of production cost — every unrecovered point is culture you paid for and threw away.
Q9
How are lyophilized powders shipped and stored?
Unopened lyophilized powders travel in insulated lanes and store cool and dry — stability windows are measured in months to years depending on the program. Once reconstituted, the clock changes: refrigerate and use within the protocol window, and never re-freeze.
Q10
Do you share characterization data before we order?
Yes. Sample COAs, the characterization baseline and retain-sample terms are shared during program discussions — documentation is the diligence asset, and it ships before the deposit, not after.
Next step
Once terms are aligned, align on specs
With the glossary aligning your communication references, the next step is to bring your target category and expected batch size (sample / 100-class / 1,000-class+) into the quoting stage: we map specifications, MOQ and lead times to each batch tier.