Newborn Bovine Calf Serum - Heat Inactivated and Gamma Irradiated
We source NBS from audited suppliers within the US. Our NBS is manufactured and processed according to the highest standards and is carefully monitored to ensure product safety and performance. After filtration and filling, the NBS is heat inactivated at 56°C for 30 minutes to protect against growth inhibiting serum complement that may be present. Then the serum is gamma irradiated at an industry standard dose of 25-40kGy.
- Average endotoxin level*: < 2 EU/ml (specification = ≤ 35 EU/ml)
- Average hemoglobin level*: < 20 mg/dl (specification = < 30 mg/dL)
- 9CFR tested
- 0.2 µm filtered
- Heat inactivated
- Gamma irradiated at a dose of 25-40kGy
- Manufactured at GMP compliant and FDA registered facility
- Standard newborn calf serum packaged in 500mL or 1 L bottles. Custom packages are also 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
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.
Newborn Calf Serum specific product test requirements and typical values are given below:
|Hemoglobin||Spectro. Assay||< 30 mg/dL|
|Osmolality||By Osmometer||240 - 360 mOsm/Kg|
|pH||pH Meter||6.5 - 8.5|
|Total Protein||Chemistry Analyzer||3.0 - 6.0 g/gL|
|Endotoxin||LAL||≤ 35 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
Product is heated at 56°C for 30 minutes to inactivate serum complement.