Mycoplasma, Sterility & Endotoxin Testing
Contamination and compendial release testing at published rates — with the method stated, because two assays with the same name are not the same test.
| Category | QC, Characterization & Acceptance Testing |
|---|---|
| Unit | One assay run on one sample or one container, plus one-off method validation per matrix |
| Lead time | 3-5 business days for PCR mycoplasma (ATCC published); 3 business days for endotoxin; 7 business days for microbial enumeration and specified microorganisms; 7 days for a rapid sterility preliminary result and 14 days for compendial USP <71> |
| Pricing | Published list price |
| Provenance | Partner manufactured |
| Data current | 2026-09-01 |
Description
The contamination layer, priced up front rather than discovered at the end of a specification. Mycoplasma is never really optional and ATCC's own published guidance names four trigger points: when a line arrives, after ten passages, after preparing a cell bank, and when in doubt — a policy that is cheap to follow at the low end of the published range. But the method decides what the result means. A luminescence assay detecting mycoplasmal enzymes is faster and much cheaper; a touchdown PCR against the 16S rRNA coding region with a stated sensitivity down to 2.5 fg of target DNA and coverage of over 120 species detects dead organisms and organisms below the enzymatic threshold. For routine screening of a working culture the cheap test is the right test; for bank release it is not. The same distinction runs through sterility: USP <71> at 14 days is the compendial reference, and a rapid alternative method must be shown non-inferior under USP <1223> for the specific product before it substitutes — one provider prices integrating the rapid method into the 14-day test at an additional fee, which tells you they expect customers to run both rather than choose. The line item buyers miss most often is method validation, which is separate from per-sample testing and is charged once per matrix. If you are testing an unusual medium, a hydrogel or a tissue construct, budget for validation before you budget for testing repeatedly; first-time buyers are routinely surprised by an invoice several times the per-sample price.
Why this is hard to buy today
Method validation is a separate line item charged once per matrix — $480.00 on endotoxin, $500.00 on microbial enumeration, $230.00 per microbe on specified organisms — and it is invisible on the per-sample price list, so a buyer testing an unusual matrix such as a hydrogel or a tissue construct receives a first invoice several times the number they budgeted from.
Price evidence
Published list and rate-card figures captured 2026-09-01, all research use; GLP and cGMP versions are quoted, not listed, at every provider surveyed. Mycoplasma: ATCC PCR-based Mycoplasma Detection Service, FTA Sample Collection Kit 136-XV, touchdown PCR against 16S rRNA detecting 120+ species, $167.00 per kit, 3-5 business days after receipt; MD Anderson core, Lonza MycoAlert luminescence enzymatic assay, $30.00 in-network / $49.00 external; Gates Center $134.27; Salk Institute mycoplasma screen $144.00 external non-profit / $180.00 external for-profit. Sterility: Compounders International Analytical Laboratory USP <71> 14-day, $270.00 for 1-9 containers / $300.00 for 10 or more; TrustPointe Analytics USP <71> by closed-system transfer in ISO Class 5, $300.00; Compounders rapid sterility with a preliminary result at 7 days, $130.00 for 1 container, $160.00 for 2-5, $175.00 for 6-10, $205.00 for 11 or more, plus $130.00 to integrate the rapid method into the 14-day test. Endotoxin: Compounders USP <85> LAL $135.00 per sample plus $480.00 method validation, 3 business days. Microbial enumeration, USP method, $160.00 per test plus $500.00 validation. Specified microorganisms, USP method, $130.00 per microbe plus $230.00 validation per microbe. A minimum working-stock check is mycoplasma only at $30.00 to $180.00; adding sterility USP <71> and endotoxin USP <85> to any panel is +$405.00 at the cheapest published rates and +$915.00 where endotoxin method validation is required.
These are supplier list prices we located and recorded, not a quotation from Wetware World. Your price depends on quantity, specification and freight, and is only binding once issued in writing.
What you must specify
A quote cannot be produced without these. Anything you leave open, a supplier will assume — usually expensively.
| # | Parameter |
|---|---|
| 01 | Sample type and matrix (cell suspension, adherent culture, tissue construct, hydrogel, medium, device extract) |
| 02 | Mycoplasma method required: enzymatic luminescence or nucleic acid amplification, and whether the report must state species coverage |
| 03 | Sterility: compendial USP <71> at 14 days, or a rapid method, or both integrated |
| 04 | Number of containers, since sterility pricing tiers on container count |
| 05 | Whether method suitability for your matrix has been established or will be billed separately |
| 06 | Endotoxin limit and whether USP <85> method validation is already in place for this matrix |
| 07 | Bioburden and specified-microorganism requirements, priced per microbe |
| 08 | Acceptance criteria and specification limits for each assay |
| 09 | Out-of-specification handling procedure, agreed in advance |
| 10 | Whether results must be issued to a third party as well as the buyer |
| 11 | Turnaround requirement, in writing |
Quality documentation
Typically available with this item. What actually ships is confirmed on the quotation, per supplier.
- Test report per assay citing the compendial method (USP <71>, <85>, <61>, <63> or equivalent)
- Stated detection method and, for mycoplasma PCR, the species coverage and sensitivity
- Method suitability or validation record for the matrix tested
- Out-of-specification investigation per the agreed procedure
Candidate suppliers
Organisations we have identified as capable. Listing does not imply a partnership, an endorsement, or that they have agreed to quote.
| Organisation | Basis for inclusion |
|---|---|
| ATCC | Publishes the PCR-based Mycoplasma Detection Service at $167.00 per FTA collection kit with a stated 3-5 business day turnaround, touchdown PCR against the 16S rRNA coding region, sensitivity to 2.5 fg of target DNA and coverage of over 120 species. Captured 2026-09-01. |
| Compounders International Analytical Laboratory | Publishes a microbiology price list: USP <71> sterility $270.00 (1-9 containers) / $300.00 (10+) at 14 days; rapid sterility $130.00-$205.00 by container count at 7 days plus $130.00 to integrate; endotoxin USP <85> $135.00 plus $480.00 validation at 3 business days; microbial enumeration $160.00 plus $500.00 validation; specified microorganisms $130.00 per microbe plus $230.00 validation per microbe. Captured 2026-09-01. |
| TrustPointe Analytics | Publishes USP <71> sterility testing at $300.00 using closed-system transfer in an ISO Class 5 environment. Captured 2026-09-01. |
| MD Anderson Cytogenetics and Cell Authentication Core | Publishes Lonza MycoAlert luminescence mycoplasma testing at $30.00 in-network / $49.00 external per sample, alongside published shipping fees of $100 domestic and $800 international or non-academic. Captured 2026-09-01. |
| Cook MyoSite | Publishes an unusually specific analytical menu — sterility by direct inoculation and membrane filtration both USP <71>, kinetic chromogenic endotoxin USP <85>, mycoplasma by NAT equivalent to USP <63>, bioburden USP <61>, gram staining and microbial identification USP <1113>, pH USP <791>, osmolality USP <785>, FTIR USP <197A>, growth promotion USP <71>, visual inspection USP <790> — with no public pricing. |
Sources
- https://www.atcc.org/products/136-xv
- https://www.atcc.org/services/cell-authentication/mycoplasma-testing
- https://compounderslab.com/services/microbiology
- https://trustpointeanalytics.com/products/usp-71-sterility-test
- https://www.mdanderson.org/research/research-resources/core-facilities/cytogenetics-and-cell-authentication-core/services.html
- https://www.cookmyosite.com/contract-services
doc WW-QC-86360 · rev 2026-09-01 · research use only · prices indicative and not binding until quoted in writing