Fetal Bovine Serum (FBS) Gamma Irradiated and Heat Inactivated
RMBIO FBS is sourced from USDA-approved suppliers and processed in our cGMP-compliant and FDA-registered facility. RMBIO FBS is processed under strict protocols that ensure sterility, high quality, and excellent growth-promotion and performance over a range of applications and cell lines.
- Triple 0.1 µm filtered
- Average endotoxin level*: < 1 EU/mL (specification = ≤ 10.0 EU/ml)
- Average hemoglobin level*: < 15 mg/dL (specification = < 30 mg/dL)
- Excellent growth promotion characteristics
- 9CFR tested
- Heat inactivated at 56°C for 30 minutes
- Gamma irradiated at 25-40kGy
- Storage conditions: ≤ -10° C
* Data based on last 10 lots produced.
Heat Inactivation 101
Heat inactivation is an industry standard treatment that helps protect against growth inhibiting immune factors like serum complement that may be present in the serum. Serum complement can have undesirable impacts on immunological endpoints like detection of neutralizing antibodies, or on the proliferation of viruses. RMBIO manufactures heat inactivated bovine serum by raising the temperature of the serum to 56°C in a water bath and strictly maintaining the condition for 30 minutes.
Gamma Irradiation 101
Gamma irradiation is a physical inactivation approach used to achieve pathogen reduction in the serum. This mitigates risk from low-level contaminants that may not be detected through viral or mycoplasma testing. RMBIO serum is gamma irradiated via controlled exposure to Cobalt 60 at an industry standard dose of 25-40kGy. Most typical viral contaminants of bovine serum are readily inactivated at this irradiation range. Advantages of gamma irradiation include:
- No potential for residual contaminants
- Widely accepted by pharmaceutical and research industries
- Accepted by regulatory agencies
- Minimal effect on product performance
- Effective virus inactivation
Gamma Irradiated and Heat Inactivated Fetal Bovine Serum (FBS) specific product test requirements and typical values are given below:
| Parameter | Method | Specification |
|---|---|---|
| Total Protein | Chemistry Analyzer | 3.0 - 4.5 g/dL |
| Osmolality | By Osmometer | 280 - 360 mOsm/Kg |
| pH | pH Meter | 6.5 - 8.5 |
| Hemoglobin | USP <90> | < 30 mg/dl |
| Albumin | Chemistry Analyzer | ≤ 4.5 g/dL |
| Endotoxin | LAL | ≤ 10 EU/ml |
| IgG | ELISA | As Reported |
| Sterility, Mycoplasma, and Viral Analysis | 9CFR 113.26, 28, 53 | Tested |
| Other Parameters | Comprehensive Chemistry Testing | As Reported |
| Heat Inactivation | Product is heated at 56°C for 30 minutes to inactivate serum complement | |
| Gamma Irradiation | 25-40kGy |