Iron Fortified, Gamma Irradiated, and Heat Inactivated Calf Serum
RMBIO produces US origin iron supplemented and heat inactivated calf serum for use in cell culture media. Supplementing iron to calf serum can enhance serum transferrin levels and in many cases be a much less expensive alternative to FBS in promoting cell growth and its effectiveness. Heat inactivation helps 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 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
- Packaged in 500mL and 1L bottles. Custom container sizes 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
Parameter | Method | Specification |
---|---|---|
Hemoglobin | SUP<90> | < 30 mg/dL |
Osmolality | Osmometer | 240 - 340 mOsm/Kg |
pH | pH Meter | 7.0 - 7.9 |
Total Protein | Chemistry Analyzer | 5.0 - 8.0 g/gL |
Endotoxin | LAL | ≤ 10.0 EU/ml |
Mycoplasma | 9CFR 113.28 | Not Detected |
Sterility | 9CFR 113.26 | No Growth |
Viral Analysis | 9CFR 113.53 | Not Detected |
Gamma Irradiated | 25-40 kGy | |
Heat Inactivation | Product is heated at 56°C for 30 minutes to inactivate serum complement. |