QC Panel: Sterility, Mycoplasma, Endotoxin, Identity & Viability
Independent release testing of cells or tissue against compendial methods before you accept delivery.
| Category | QC, Characterization & Acceptance Testing |
|---|---|
| Unit | One assay run on one sample, or one full release panel per lot |
| Lead time | 1-4 weeks depending on assay; sterility and bioburden incubations impose hard minimums |
| Pricing | By quotation |
| Provenance | Partner manufactured |
| Data current | 2026-09-01 |
Description
The independent test layer that turns a shipment into an accepted delivery. Cook MyoSite publishes an unusually specific analytical service list which we use as the reference menu: cell count and viability; sterility testing by direct inoculation and by membrane filtration, both USP <71>; kinetic chromogenic endotoxin, USP <85>; mycoplasma assay by NAT method equivalent to USP <63>; bioburden, USP <61>; gram staining and microbial identification, USP <1113>; pH, USP <791>; osmolality, USP <785>; FTIR material identification, USP <197A>; growth promotion of media, USP <71>; visual inspection, USP <790>; plus flow cytometry, fluorescent microscopy, culture monitoring, custom gene expression assays, myogenic differentiation by immunohistochemistry and qPCR, and a desmin myogenic content assay. Those methods are backed by more than two decades of clinical manufacturing experience and validated QC methods for autologous cell therapy. STR identity profiling is the standard identity method for cell lines and is widely available, though we did not verify it on a named supplier page in this pass. No public pricing exists for any of it.
Why this is hard to buy today
Most buyers accept a supplier's own certificate of analysis because arranging independent release testing means finding a second lab, writing acceptance criteria and negotiating what happens on a failure — work nobody has packaged.
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 (cell suspension, adherent culture, tissue, medium, device) |
| 02 | Assay list required from the compendial menu |
| 03 | Acceptance criteria and specification limits for each assay |
| 04 | Number of samples and lots |
| 05 | Whether results must be issued to a third party (e.g. the buyer as well as us) |
| 06 | Turnaround requirement |
| 07 | Whether a GMP-grade or research-grade report is required |
Quality documentation
Typically available with this item. What actually ships is confirmed on the quotation, per supplier.
- Test report per assay against the stated method
- Compendial method citation (USP chapter) where applicable
- Out-of-specification handling procedure agreed in advance
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 |
|---|---|
| Cook MyoSite | Contract services page lists muscle and adherent cell production, cryopreservation at any scale, procurement from specific donor populations, custom media, and phase-appropriate GMP manufacturing; 3,470 sq ft ISO 7 / ISO 5 cleanroom. No public pricing. |
| Visikol (MatTek / Sartorius) | Service-only CRO: standard histology, digital pathology, pre-validated and custom multiplexed immunofluorescence panels, image analysis, cell counting, morphometry, viability and 3D in vitro assays. No tissue product of its own, which makes it a clean independent QC subcontractor. |
Sources
doc WW-QC-62912 · rev 2026-09-01 · research use only · prices indicative and not binding until quoted in writing