Formula Fed Bovine Calf Serum - Heat inactivated and Gamma Irradiated
RMBIO produces high-quality, low hemoglobin, heat inactivated, gamma irradiated, US sourced calf serum for use in cell culture media. Bovine calf serum is often used as an alternative to Fetal Bovine Serum (FBS) as it’s available at a fraction of the price. This product is heat inactivated to help protect against growth inhibiting immune factors like serum complement that may be present in the serum. The serum is then gamma irradiated at an industry standard dose of 25-40kGy.
- Sterile 0.2 µm filtered
- Average endotoxin level*: < 2 EU/ml (specification = ≤ 10.0 EU/ml)
- Average hemoglobin level*: < 15 mg/dL (specification = < 30 mg/dL)
- 9CFR tested
- Heat inactivated at 56°C for 30 minutes
- Gamma irradiated at a dose of 25-40kGy
- For use in diagnostics or as cell culture medium
- Manufactured at our GMP compliant and FDA registered facility
- Large volume lot sizes available
- Custom bottle sizes and containers available
- 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 calf 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
Formula Fed Bovine Calf Serum specific product test requirements and typical values are given below:
Parameter | Method | Specification |
---|---|---|
Total Protein | Chemistry Analyzer | As Reported |
Osmolality | By Osmometer | 260 - 340 mOsm/Kg |
pH | pH Meter | As Reported |
Endotoxin | LAL | As Reported |
Hemoglobin | USP <90> | ≤ 30 mg/dl |
Sterility, Mycoplasma, and Viral Analysis | 9CFR 113.26, 28, 53 | Tested |
Appearance | Visual | Clear Yellow Amber |
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 |
Documents
Calf Serum Safety Data Sheet