FBS Data Sheet

Fetal Bovine Serum

Catalog Number 43613 New Zealand Origin

Catalog Number 43635 USDA Origin

Catalog Number 43640 U.S. Origin

Catalog Number 43652 Australian Origin

Introduction

For decades, Fetal Bovine Serum (FBS) has been the first choice for supplementing cell culture media for the purpose of culturing cells. This is due to its inherent nutritional, growth, hormonal, and attachment factors that are essential for cell propagation.

Raw Serum Collection

Fetal blood is collected at various abattoirs locat­ed throughout the United States, Australia, New Zealand, and USDA (United States Department of Agriculture) approved facilities in Mexico and Central America. Whole fetal blood is collected via aseptic cardiac puncture and allowed to clot at refrigerated temperature. The serum is then centrifuged and decanted from the clot. The raw serum is then pooled and immediately frozen. J R Scientific pre-tests all raw lots for endotoxin and hemoglobin levels prior to final processing to en­sure they meet our stringent quality requirements.

Processing and Finishing

J R Scientific 2000L batch process utilizes a com­pletely disposable process for all of our FBS lots. The serum never comes into contact with parts requiring washing or CIP/SIP (Clean In Place/ Steam In Place), thusly eliminating the potential for cross-contamination with other products or cleaning agents. All lots are triple 0.1m filtered, a process that has been validated to remove my­coplasma. Serum is aseptically dispensed into gamma sterilized bottles in a HEPA filtered Class 100 cleanroom.

Storage and Thawing

FBS should be stored frozen at -10°C to -20°C. Prod­uct is stable for 5 years from the date of manufacture if kept at frozen temperature.

Remove the bottle from the freezer and allow to accli­mate to room temperature for 10 minutes. Place each bottle into a 30-37°C water bath and allow to thaw completely, ensuring each bottle is agitated or swirled every 5-10 minutes. After thawing, use the serum or place into a refrigerator for up to 3 weeks. JRS recom­mends the product not undergo multiple freeze-thaw cycles, aliquots should be made.

Turbidity or flocculent material may be observed upon thawing or prolonged storage at refrigerated tempera­tures, especially if the serum is not periodically swirled during the thawing process. The precipitate or floc­culent material is normal, non-toxic and not detrimental to the performance of the serum. Gentle warming and swirling of the bottle will generally allow the material to go back into solution.

Batch Variation

As with any biological product, FBS can vary from lot to lot. JRS performs either cell culture or the MTT as­say on each lot to ensure its growth promoting capa­bilities and non-cytotoxicity. However, no lot of FBS will work on every cell line. Therefore, we recommend each end-user test the lot on their particular cell line in order to determine its suitability for their intended use.

Traceability

The raw starting material used in the production of J R Scientific’s FBS is collected from USDA or other relevant government inspected and approved slaugh­terhouses in the country of origin. A Certificate of Origin is available for each lot and JRS is able to trace any lot back to the abattoir in the country of origin.

BSE

The countries and/or regions within the countries where the raw blood is collected and processed into raw FBS are, as defined by the USDA/APHIS, free from BSE and FMD and eligible for importa­tion into the U.S. for final processing and distribu­tion.

The USDA considers the USA to be a BSE-Free (Bovine Spongiform Encephalopathy-free) country. None of J R Scientific’s (JRS) Fetal Bovine Serum contain or are derived from specified risk materi­als defined in Commission Decision 97/534/EC. Specified risk material as defined by the EC (Eu­ropean Community) include: (1) The skull includ­ing the brain and eyes, tonsils and spinal cord of bovine animals aged over 12 months and of bo­vine and caprine animals which are aged over 12 months or have permanent incisor tooth erupted through the gum; (2) The spleens of bovine and caprine animals.

Virus Screening

Fetal Bovine Serum is tested for Adventitious Viral Agents (AVA) according to 9CFR113.53. These AVA include, but are not limited to, IBR, PI3, and BVD. All serum imported from Mexico and Cen­tral American USDA approved abattoirs as well as Australian AQIS approved abattoirs must undergo USDA safety testing prior to release. USDA safety test screens for Bluetongue Virus and Akabane disease.

Of particular concern, the family of BVD viruses has been grouped into two genotypes, Type 1 and Type 2. Each of the genotypes has also been subdivided into cytopathic and non-cytopathic biotypes. One of the distinctions between the two biotypes is based on how they behave in cell culture. The cytopathic biotype will damage cell cultures and the non-cytopathic biotype will not.

Unlike other suppliers, JRS tests for both biotypes and we only report the results for the Type 1 and 2 cytopathic biotypes as these are the types of significance to researchers performing cell culture.