Fetal Bovine Serum (FBS) Gamma Irradiated
RMBIO FBS is sourced from USDA-approved suppliers and is 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.
- Low endotoxin and hemoglobin levels
- Excellent growth promotion characteristics
- Average endotoxin level*: < 1 EU/mL (specification = ≤ 10.0 EU/ml)
- Average hemoglobin level*: < 15 mg/dL (specification = < 30 mg/dL)
- Total protein: 3.0-4.5 g/dL
- Triple 0.1 µm sterile filtration
- 9CFR-tested
- US origin
- Storage conditions: ≤ -10° C
- Gamma irradiation 25-40kGy
*Data based on last 10 lots produced.
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 Fetal Bovine Serum (FBS) specific product test requirements and typical values are given below:
Parameter | Method | Specification |
---|---|---|
Total Protein | Colorimetric Assay | 3.0 - 4.5 g/dL |
Osmolality | By Osmometer | 280 - 340 mOsm/Kg |
pH | pH Meter | 7.0 - 8.0 |
Hemoglobin | Contract Lab | < 25 mg/dl |
Albumin | Contract Lab | 1.7 - 3.4 g/dL |
Endotoxin | LAL | < 10 EU/ml |
IgG | ELISA | As Reported |
Electrophoretic ID | Gel Electrophoresis | Characteristic |
Other Parameters | Comprehensive Chemistry Testing | As Reported |
Gamma Irradiation | 25-40kGy |