Products

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Atlas Biologicals, Inc is one of the only companies within the contiguous United States that manufactures and produces Fetal Bovine Serum as its primary product, the great majority of which is sourced in the United States.

We believe that we are able to control our process and product quality at a much higher level using our U.S.-based supply chain as opposed to foreign sources.

All of our serum is processed at a GMP facility which complies with the highest level of industry standards.

We do offer serum produced from blood collected in approved countries outside of the United States to our customers who do not have specific origin requirements and are looking for adequate performance at a lower cost. Upon request.

We are certain that we can find a lot of serum for any type of cell culture application.

Product Information

100% United States Origin U.S. Flag – Traceable back to the packing plants located in the United States. Collected and processed according to our proprietary procedures which assure the highest level of control, quality and lot to lot consistency. All of our U.S. Origin material is triple 0.1 micron filtered in an FDA registered facility and manufactured in accordance with current Good Manufacturing Practices (cGMP).

Upon request: USDA Approved Sourcing – This is a term that is used for FBS produced from blood collected in countries outside of the United States that have been approved by the USDA (United States Department of Agriculture) for export of beef products into the United States Approved countries must be free from exotic bovine viruses for extended periods of times and USDA maintains and updates the list on a regular basis. When foreign serum enters the country, it is quarantined in an approved USDA holding facility and representative samples are tested for exotic viruses. Upon completion of testing accompanied by negative results for the viruses in question, the serum is released and may be further processed and packaged for sale.

Eligible countries for export into the U.S. as of December 2009: Australia, Canada, Chile, Costa Rica, Honduras, Iceland, Japan, Mexico, New Zealand, Nicaragua, Uruguay.

Serum produced from blood sourced outside of the country, with few exceptions, is not subject to the controls and regulations that are in place in the United States. There are reputable companies whose main interests are collecting and processing blood in approved countries but it does require a presence to assure the proper controls. Packing plants in approved countries are supposed to be inspected by USDA officials on an annual basis, whereas, in the United States the inspectors are in the plants checking for diseases and signs of sickness every day during all hours of operation. Packing plants in the United States are required to report the number of liters of fetal blood taken out of each facility. In most approved countries the packing plants are not required to report this information which makes it possible for blood or raw serum from unapproved countries to make its way into those approved countries and then come into the United States. It's no surprise that when blood prices were high several years ago that there was a substantial increase in serum coming from countries whose cattle populations could not mathematically support the volumes of serum being produced.

Serum originating from some of the source countries that are considered the most pristine based upon geographical isolation were producing two to three times the quantities that their cattle populations could sustain, and in addition, those sources may not have been as pristine as they were perceived to be.

Example: Australia is considered to be a source that is free from most exotic viruses. Currently, USDA requires that all blood products originating from Australia be tested for viruses that any other approved country must be screened for PLUS akabane virus.

For more information: http://en.wikipedia.org/wiki/Akabane_virus

There is no definitive way of determining the true origin, handling or quality of serum produced from blood sourced outside of the United States unless one actually goes and monitors it.

Specialty Services

Lot Sizes: Atlas Biologicals produces finished lots ranging from 500 liters to 2,500 liters.

Samples: Atlas will provide, at no charge, 50 mL samples which are representative of the 500 mL bottles in a particular lot or batch of finished fetal bovine serum. We will reserve and hold the number of 500 mL bottles that you would want to purchase providing the sample works for your application. Reserves are held for up to 1 month during sample evaluation.

Lot Matching: Atlas Biologicals keeps records of all production lots of sera with regard to specific cell lines and performance. For most of our customers' applications we can match previously purchased lots with current lots in inventory. If you have not purchased from us, just provide information regarding cell lines and applications we'll find a lot that will work for you.

Storage: Bovine serum requires long term storage at -10°C to -30°C. If necessary, it may be stored at -80°C, however, caution must be taken. Certain plastics can become brittle at this temperature and may crack if bumped or hit on hard surfaces. Bottles stored at -80°C should be placed in a freezer at -10°C to -30°C for at least 24 hours prior to use to minimize possible damage to the container. Thawed serum may be stored up to 2 weeks in a refrigerator at 2°C to 8°C providing the sterility has not been compromised.

Expiration Dating: Atlas Biologicals places a 4 year expiration date from the time of final filtration on our fetal bovine serum. In all actuality, the product can be used long after the expiration date providing it has been properly stored. We have conducted extensive chemical and cell growth testing on our fetal bovine serum and also from other manufacturers from 1 to 6 years past the expiration date reported on the label. Results have shown that the serum samples we tested showed similar results to newer lots. If you have "expired" serum and don't want to throw it away simply because it is past the expiration date on the label, test it side by side with a control and compare the results.

Packaging Options: Custom packaging options are available including multi-layered media bags of various sizes. Contact us for more information.

Third Party Testing: All of our finished fetal bovine serum is quality tested by third party laboratories according to CFR, USP, and GLP procedures. This assures unbiased results. Many producers perform their own testing which could introduce that variable. Also, the assay procedures may be different than what is accepted.

Additional Testing: If a customer requires specific testing of a serum component that is not included in our standard testing, please call or e-mail us and ask.

Product Specifications: Raw Fetal Bovine Serum (prior to filtration and packaging)

Endotoxin <10 EU/mL
Hemoglobin <25 mg/dL
Total Protein 3.0 – 4.5 mg/dL
Osmolarity 260 – 340 mOsm/kg
pH 6.7 – 8.0
Electrophoretic ID Characteristic

Product Specifications: Finished Fetal Bovine Serum (after triple 0.1 micron filtration)

All of the above, plus:

Sterility as stated in USP Negative
Mycoplasma Negative
Viral Agents, 9CFR Negative
Serum Chemistry Panel Report results

Gamma Irradiation – Upon request, serum can be gamma irradiated at a standard dose of 25 – 40 kGy (kilograys) which has been validated to kill seven (7) logs of BVDV (bovine viral diarrhea virus). Different dose levels can be accommodated if necessary. The irradiation processing facility is in compliance with FDA 21 CFR part 820 requirements, ISO 13485 registered, and AAMI/ANSI/ISO 11135, AAMI/ANSI/ISO 11137, EN 550, and EN 552 compliant for product acceptance in U.S. and international markets.

Heat Inactivation - Heat inactivation is a process in which finished serum is placed in a heated water bath and maintained at a temperature of 56&dec;C for 30 minutes. This is the most common procedure used. Some procedures specify 60 minutes and others even longer. If a customer is adamant about heat inactivation, we can perform it, but we do not recommend heat inactivation of fetal bovine serum or any other animal serum that is being used for cell culture. In fact, it can have detrimental effects on the serum's ability to support cell growth as well as causing components to precipitate out giving the appearance of contamination.

Charcoal Treatment - Charcoal treatment of serum is an effective process for removing hormones and steroids. It has also been used for improving immunoassay systems. Charcoal treated, charcoal filtered or charcoal stripped fetal bovine serum are all terms for the same product. It is made by exposing the serum to a mixture of dextran coated activated charcoal for a period of time. This product is typically very expensive and most labs do not use very much so we offer a procedure for preparing charcoal treated fetal bovine serum. There are several different methods but the actual materials and concentrations are very similar. If the volume of serum you need is 10 – 50 mL, the use of 50mL sterile centrifuge tubes makes the process simpler.

IgG – IgG levels in normal fetal bovine serum can range from 50 – 1000 ug/mL. Low IgG FBS is typically below 50 ug/mL and can be produced several ways. The easiest is by selectively segregating the blood from first trimester animals and screening for low levels of IgG. This adds more expense and is very time consuming. It can take many months to accumulate enough volume to justify production. It can also be produced by mechanically removing IgG via a binding matrix like Protein A and is usually done in a column configuration. Again, this is very expensive and can compromise the performance of the serum. If your application does require low IgG levels we can supply it for you.

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