Table 1.
Extended.
|
Screening and Sterilization |
Manufacturer Stated Testing |
Regulations |
| Donor screening, serological testing, viral inactivation, electron beam irradiation | Lots tested in vitro prior to formulating final product | FDA: K103742 |
| Donor screening, serological testing, USP71 sterility testing | Lots tested via athymic mouse muscle pouch assay and alkaline phosphatase assay | FDA: K053218, K080399, K040262 |
| Donor screening, serological testing, USP71 sterility testing | Lots tested via athymic mouse muscle pouch assay and alkaline phosphatase assay | FDA: K062205, K042829, K121313 |
| Donor screening, serological testing, viral inactivation, USP71 sterility testing | Final product lots tested for osteoinductivity via athymic rat model | FDA: K051188, K051195 |
| Donor screening, serological testing, viral inactivation, USP71 sterility testing | Final product lots tested for osteoinductivity via athymic rat model | FDA: K051188, K051195 |
| Donor screening, serological testing, viral inactivation, USP71 sterility testing | Final product lots tested for osteoinductivity via athymic rat model | FDA: K051188, K051195 |
| Donor screening, serological testing, viral inactivation, USP71 sterility testing | Final product lots tested for osteoinductivity via athymic rat model | FDA: K051188, K051195 |
| Donor screening, serological testing, viral inactivation, USP71 sterility testing | Final product lots tested for osteoinductivity via athymic rat model | FDA: K082615, K122513 |
| Donor screening, serological testing, viral inactivation, electron beam irradiation | Final product lots tested for osteoinductivity via athymic rat model | FDA: K072265, K082463, K082002, K081950, K080462 |
| Low-dose gamma irradiation, BacteRinse sterilization | Final product lots tested for osteoinductivity in an animal model | AATB guidelines |
| Screened donors, serological testing, viral inactivation | N/A | AATB guidelines |
| Screened donors, serological testing, viral inactivation, antimicrobial treatment | Each lot screened for presence of active cells | AATB guidelines |
| N/A | N/A | FDA: K141841, K091302, K063124 |
| N/A | N/A | FDA: K090850, K082575, K081979, K082073 |
| N/A | N/A | FDA: K103173, K083033, K081439, K072184 |