Iron Fortified and Gamma Irradiated Calf Serum
- Dialyzed
RMBIO produces US origin iron supplemented 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. The serum is 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
- 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.
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 |