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General Information |
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Through continuous product and process improvements we help set the industry standard for safe, quality serum products.
Our unique validated SER-TAIN™ process for gamma irradiation of serum provides a further level of safety by delivering a certified dose of radiation to each bottle of irradiated serum. SER-TAIN™ gamma irradiation can inactivate up to six logs of many undetectable adventitious agents often present in serum.
SAFC Biosciences is also able to source and process serum in multiple countries of origin. This enables customers to establish a risk management, multi-sourcing strategy through a single supplier.
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SAFC Biosciences has been granted a Certificate of Suitability of Monographs of the European Pharmacopoeia for many of its serum products. These sera are in compliance with the European Directorate for the Quality of Medicines (EDQM) monograph entitled "Products with risk of transmission of agents of animal spongiform encephalopathies" (Ph. Eur. Illrd Ed., no. 1483, 2000). Certification was granted within the framework of the procedure established by the European Pharmacopoeia Commission [Resolution AP-CSP (99) 4]. Our serum products are tested for adventitious agents per methods compliant with 9CFR 113.53, EMEA/CPMP/BWP/1793/02, EMEA/CVMP/743/00 and Regulation (EC) No. 1774/2002 where applicable. |
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All sera that are sourced from abattoirs in the United States (US) are collected at United States Department of Agriculture (USDA) inspected facilities. All slaughtered animals used for collection of serum are deemed healthy and suitable for human consumption. Donor sera are collected from monitored herds maintained under veterinary care. SAFC Biosciences performs qualifying and routine audits at serum collection and processing sites. Raw sera are pre-tested in advance according to established criteria.
For our Australian and New Zealand products, blood collection takes place at facilities inspected and qualified by AQIS or MAF respectively. Serum meets USDA standards and is processed in our ISO accredited facilities. Both Australia and New Zealand are free from Bovine Spongiform Encephalopathy (BSE) and other diseases such as Foot and Mouth Disease and Rinderpest.
When serum is imported into the US, it must meet strict safety testing requirements established by the USDA, Center for Veterinary Biologics (CVB). The USDA testing includes inoculation of serum into sheep, then testing the sheep for antibodies for adventitious agents (AVA) specific to the region or country from which the material originated. Our serum-processing facility in Lenexa, Kansas is inspected routinely by the USDA for qualification as a quarantine site.
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A Certificate of Analysis indicating the country of origin is prepared for each lot of serum. SAFC Biosciences guarantees traceability of serum materials to the point(s) of collection and the dates the whole blood was collected. The list of abattoirs, their identification numbers and material collection dates is reviewed by Quality Assurance. This information is retained with the batch record and can be made available upon customer request. |
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Blood is aseptically collected under controlled conditions, via cardiac puncture or venipuncture, and allowed to clot under controlled conditions. After centrifugation, the serum is decanted from the clot. The raw serum is then pooled and immediately frozen. Thawed raw serum is processed through a series of membrane filters of descending pore size. Fetal bovine serum (FBS) is filtered through three 0.1 µm filters and pooled. All other sera are filtered through 0.2 µm filters. Filter integrity tests are conducted pre- and post-filtration by bubble point and diffusive flow methods. All filtered serum meets the sterility assurance level of 10-3. |
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Serum should be stored frozen at -10 to -40 C. Do not store in a frost-free freezer. Avoid repeated thawing and freezing. Once thawed, serum can be stored at 2 to 8 C up to 4 weeks.
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Frozen serum is typically shipped via air in insulated containers packed with dry ice.
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In cell culture laboratories, serum is commonly used as a supplement to basal growth medium. Serum provides a wide variety of macromolecular proteins, low molecular weight nutrients, carrier proteins for water-insoluble components, and other compounds, such as hormones and attachment factors necessary for in vitro growth of cells. Serum adds buffering capacity to the medium and binds or neutralizes toxic components in the growth milieu.
The selection of an appropriate serum supplement for cell culture applications is primarily dependent on the chemical definition of the type of cell to be grown, the basal medium, and the culture system being employed. The objectives of the application, whether research or commercial, also should be established before selecting a serum supplement.
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Samples of sera are available for evaluation prior to purchase, with reserved material if required. If a reservation is established, SAFC Biosciences will confirm the quantity and specific pre-qualification testing and reservation period at the time of sampling.
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Upon request, serum can be heat inactivated and/or gamma irradiated. For custom requirements, please call our Technical Services department.
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