Quality Control

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History

For decades, fetal Bovine Serum (FBS) has been the premier choice for supplementing cell culture media. It contains a complex mix of growth factors, hormones, proteins, lipids, and minerals essential for cell growth.
 

Collection and Traceability

Our Fetal Bovine Serum is sourced from USDA-approved abattoirs in the United States, Australia, Mexico, and various Central American countries. Whole fetal blood is collected via cardiac puncture into 1L to 2L bags using a closed system. After collection, the blood is allowed to clot at refrigerated temperatures. Following clotting, red blood cells are removed by centrifugation. The resulting raw serum is pooled into batches of 500L to 2,000L, dispensed into bottles, and frozen. Each lot is pre-tested for endotoxin and hemoglobin levels to meet our quality specifications.
 
Each lot of FBS includes a Certificate of Analysis (COA) and a Certificate of Origin (COO), ensuring traceability back to the abattoir in the country of origin.
 

Processing

All lots are triple 0.1 micron filtered, a validated process designed to remove mycoplasma and adventitious agents. The serum is aseptically dispensed into gamma-irradiated sterile bottles within a HEPA-filtered Class 100 cleanroom.
 

Storage

FBS should be stored between -5°C and -80°C. Product stability is guaranteed for five years from the date of manufacture when stored properly. We do not recommend storage in auto-defrost or frost-free freezers, as multiple freeze/thaw cycles can happen.
 

Thawing

To thaw, remove the bottles from the freezer and allow them to acclimate to room temperature for 10 minutes. Place each bottle in a water bath at 37°C until fully thawed, swirling every 5 to 10 minutes. After thawing, FBS can be refrigerated for up to three weeks. To avoid degradation, we recommend aliquoting the serum instead of refreezing.
 
Turbidity or flocculent material may occur upon thawing or prolonged refrigeration. This precipitate is normal, non-toxic, and does not affect the performance of FBS.
 

Lot Variability

As a biological product, FBS exhibits inherent variability between lots. While we conduct cell culture assays on each batch to ensure a minimum growth rate, not all lots will be suitable for every cell type. Omega provides no-cost samples upon request for end users to test specific lots before purchase.
 

Product Profile

Sterility:

Batches undergo a GMP microbiology test that ensures our products are free of viable microorganisms.
 
  • Endotoxin Testing: determined using kinetic turbidimetric and chromogenic methods.
 
  • Hemoglobin Testing: Concentration measured via a colorimetric assay assessing peroxidase activity.
 
  • Mycoplasma Testing: determined used Polymerase Chain Reaction and 9CFR 113.28
 
  • Viral Testing: Assures absence of viruses, including Bovine Viral Diarrhea (BVD), Infectious Bovine Rhinotracheitis (IBR), and Parainfluenza Type 3 (PI3). All FBS imported from Canada, Mexico, and Central America undergoes USDA safety testing for Bluetongue Virus.
 
  • Bovine Spongiform Encephalopathy (BSE): The USDA considers the USA to be a BSE-free country and recognizes Australia, New Zealand, Mexico, Canada, and parts of Central America as free of BSE. Raw blood is deemed free of BSE and FMD, making it eligible for importation into the USA for final processing and distribution.
 

Additional Treatments

 
  • Heat Inactivation (Cat # FB-02, FB-12): Thawed and heated in a water bath at 56°C for 30 minutes, with continuous swirling to ensure complete inactivation of complement proteins.
 
  • Gamma Irradiation (Cat # FB-09, FB-19): Exposed to 2.5 – 3.5 mRads (25-35 kGy) of radiation. A Certificate of Irradiation accompanies each lot.
 
  • Dialysis (Cat # FB-03, FB-07): Reduces low molecular weight components using a molecular weight cut-off of 10,000 dialyzed against 0.15M NaCl.
 
  • Charcoal Dextran Stripped/Treated (Cat # FB-04, FB-14): Reduces steroid and hormone concentrations, ensuring progesterone levels are below 0.2 ng/ml. A hormone panel is conducted pre- and post-treatment.