Fetal Bovine Serum (FBS) IgG Depleted and Gamma Irradiated
RMBIO uses premium grade FBS as the starting material for our IgG Depleted FBS. We then utilize a series of chromatography procedures to reduce the IgG content. The resulting FBS has an average IgG level of less than 5 µg/mL and cell growth performance comparable to the starting material. The average level of IgG in normal fetal calf serum is approximately 70-300 µg/mL.
- Gamma irradiated at 25-40kGy
- Total IgG content below 5 µg/mL
- IgG depleted FBS performs well in monoclonal antibody production
- Triple 0.1 µm filtered
- Large lot sizes >1000 Liters available
- Custom packaging sizes available upon request
- All fetal bovine serum is fully traceable and is sourced from audited suppliers
- Storage conditions: ≤ -10° C
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
IgG Depleted Fetal Bovine Serum (FBS) specific product test requirements and typical values are given below:
Parameter | Method | Specification |
---|---|---|
IgG | ELISA | < 5.0 |
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 |
Electrophoretic ID | Gel Electrophoresis | Characteristic |
Other Parameters | Comprehensive Chemistry Testing | As Reported |
Gamma Irradiated | 25-40kGy |