Formula Fed Bovine Calf Serum - Gamma Irradiated (New)
RMBIO produces high quality, low hemoglobin, US sourced calf serum for use in diagnostics and cell culture media. Bovine calf serum provides the start for successful cell growth at a fraction of the price of Fetal Bovine Serum due to its availability. Our calf serum is then irradiated at an industry standard dose of 25-40kGy.
- Average endotoxin level*: < 2 EU/ml (specification = ≤ 10.0 EU/ml)
- Average hemoglobin level*: < 15 mg/dL (specification = < 30 mg/dL)
- 9CFR tested
- Sterile 0.2 µm filtered
- Gamma irradiated at 25-40kGy
- Manufactured at our GMP compliant and FDA registered facility
- Packaged in 500mL and 1L bottles. Custom container sizes available upon request.
- 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
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 |
Gamma Irradiation | 25-40kGy |