CELL CULTURE. Fetal Bovine Serum product line. Quality Value Service

Transcription

1 CELL CULTURE Quality Value Service Fetal Bovine Serum product line

2 Atlanta Biologicals Dedicated to Excellence for nearly Four Decades The quality of Atlanta Biologicals products is built on almost 40 years of research and development. From the beginning, Atlanta Biologicals has focused on high standards for the manufacture and quality assurance of superior cell culture products. Our ongoing commitment to continuous quality improvements and innovations is the key to our success in establishing Atlanta Biologicals as a premier supplier of products for cell culture applications. Since our inception, we have expanded our manufacturing capacities and quality control laboratories, as well as our sales and customer service departments multiple times before establishing all of our current operations in a new, custom designed, state-of-the-art facility in Atlanta Biologicals academic and industrial customers today benefit from accelerated processing of inquiries and orders, expanding product line, and products of the highest quality manufactured on-site. With close to 40 years of experience behind us, we have developed efficient processing guidelines for each product manufactured that guarantee unsurpassed quality and consistency from lot-to-lot. Our qualification programs for raw and ancillary materials assure that our rigorous requirements regarding material selection, traceability, characterization and suitability for use are met. Additionally, each individual lot of product manufactured is subjected to an extensive series of robust quality control testing procedures by our QA/QC department and must comply with our stringent specifications and acceptance criteria before release for distribution. This strict control over the manufacturing processes results in the highest levels of product quality and performance. At Atlanta Biologicals we believe in a customer care approach and remain dedicated to every project we participate in. Our highly trained sales team, technical and customer service departments provide fast, friendly, reliable and personalized assistance in selecting quality products to meet any research objective. We are constantly innovating new ways to streamline our services to customers and advance the quality of our products, while continuing to offer highly competitive pricing within the market. Atlanta Biologicals, a world class supplier of cell culture products, offers unparalleled commitment to high quality products, exceptional product value and excellent customer service to research laboratories and biotechnology-based industries, both large and small. When choosing Atlanta Biologicals, scientists are relying on consistent delivery of the highest quality products available. 1

3 Atlanta Biologicals Helping your research grow one cell at a time Tissue culture dates back to the beginning of the 20th century when small tissue fragments were cultured for the first time. Several decades later, the first cell culture techniques to grow dispersed cells were developed. Under appropriate culture conditions most animal cells will proliferate, and even express differentiated properties in vitro. Continuous advances in research and development lead to the need to adapt and propagate extremely specialized cells. Nowadays, cell cultures play an important role in biomedical research, and in the manufacture of many vaccines and medicinal products. Cells in culture require a source of nutrition that is provided by the cell culture medium. The majority of media currently in use require supplementation with animal or human serum. Since the beginning of modern cell culture, the demand for high quality sera, media and cell culture supplements has increased at a steady pace. Atlanta Biologicals, a recognized specialist in cell culture products, offers a complete line of cell culture sera, serum alternatives, classical and specialty media, media supplements, cell culture reagents, cell separation media and cytokines. Animal and Human Sera Most cell cultures depend on serum for successful growth and maintenance of adherent or suspension cells. Serum is a complex organic solution containing proteins, polypeptides, growth factors, amino acids, nucleosides, lipids, carbohydrates, hormones, vitamins and other components. It serves not only as a nutrient, but also promotes other cell functions such as proliferation and attachment. Sera of bovine origin, predominately Fetal Bovine Serum, are the most widely used animal sera for culturing cells. On occasion, non-bovine animal sera are used for select applications, and human sera are used in conjunction with a number of human cell lines. Atlanta Biologicals manufactures and supplies a wide range of animal and human cell culture sera to meet the requirements of even the most demanding cell types. Specializing in Fetal Bovine Serum (FBS), Atlanta Biologicals offers one of the most extensive FBS product lines within the industry. Classical Media A multitude of chemically defined media formulations are in existence, many of them variations of media developed earlier. Each medium formulation of these versatile media is typically composed of greater than 30 constituents with many in extremely minute amounts. Atlanta Biologicals offers a large array of classical media formulations that are commonly used in biomedical research applications. Other Reagents and Supplements Many other reagents and supplements are used in conjunction with cell culture applications. Atlanta Biologicals supplies laboratories with high quality Balanced Salt Solutions, Cryopreservation Media, Cell Separation Media, Media Supplements, Biological Buffers, Cell Dissociation Reagents, and Cytokines. Custom and Specialty Media The diverse requirements of specialized cell culture applications frequently cannot be met by the standard classical media available today, and modifications to their formulations are necessary. Atlanta Biologicals offers rapid custom media manufacturing services, even for small quantities and in a variety of packaging sizes. In recent years there has been an increased emphasis on specialty media that support the growth of selective cell types. In response to these demands, Atlanta Biologicals has developed a line of specialty media tailored to the needs of hybridoma cell lines. These media are formulated without the use of animal-derived components and are completely protein-free. They support serumfree long-term growth of hybridomas and related cells capable of expressing monoclonal antibodies and other protein products, while reducing cost associated with downstream processing due to the absence of protein and peptides. 2

4 Fetal Bovine Serum The Essential Element to Cell Culture Success Fetal bovine serum (FBS) is the ideal medium growth supplement and generally preferred over other types of sera. Its high levels of nutrients and optimal combination of growth factors makes Fetal Bovine Serum the most effective growth promoter for virtually any cell culture system. In addition, the significantly lower content of antibodies compared to adult and newborn sera minimizes the risk of antibody cross reaction with cells in culture. Early on, Atlanta Biologicals recognized the vital importance of Fetal Bovine Serum for cell culture technology. We developed uncompromising manufacturing processes and quality assurance procedures from collection of the raw material to manufacture of the final product; thus ensuring reliable and consistent delivery of the highest quality FBS to our customers. In earning a reputation for absolute commitment to consistent quality and the highest level of customer service, Atlanta Biologicals is today a leading manufacturer and supplier of Fetal Bovine Serum offering a considerable selection of Fetal Bovine Serum grades and Specialty Fetal Bovine Sera. Collection and Processing The quality of Fetal Bovine Serum is determined primarily at the blood collection site and the raw serum processing center. Proper collection is fundamental to maintaining the natural growth-promoting properties of fetal blood, thus achieving consistent and superior performance of the final Fetal Bovine Serum products. Realizing the importance of direct control over the raw material production process, Atlanta Biologicals has established a global network of Fetal Bovine Serum collection sites that is continuously being expanded. To date, we are one of a very few companies worldwide that are truly vertically integrated organizations, maintaining control over all steps of Fetal Bovine Serum production from blood collection, through initial raw material processing, to final filtration, bottling and quality control. This stringent control over the entire process from start to finish is the key to our success. It ensures product safety through absolute transparency and traceability, a consistent supply of FBS lots with excellent cell growth-promoting characteristics, and minimized lot-to-lot variation at competitive prices. We consider this level of control a necessity in order to avoid potential quality inconsistencies resulting from reliance on independent raw serum collectors, and to guarantee a stable, traceable serum supply for Atlanta Biologicals even in times of low availability. Atlanta Biologicals innovative blood collection, serum separation, and final filtration methodologies are a result of our decades of expertise, and assure that the final product meets our highest quality standards. The collection of fetal bovine blood is performed exclusively in designated facilities inspected by local animal health authorities and approved by the USDA, following strict standard operating procedures and biosecurity standards. We aseptically collect the blood using a closed-system method and transfer the blood quickly to our regional processing centers. There, serum is separated from blood under strict temperature control utilizing our rapid processing technology. The raw material is then evaluated for compliance with our strict raw material specifications and transferred to our main production facility. Over the years, we have continuously improved our processing methods in our quest to preserve the natural growth-promoting properties of the blood and to minimize the risk of contamination; thus yielding the highest quality Fetal Bovine Serum suitable for even the most fastidious cell types. 3

5 Filtration and Quality Assurance Serum for further processing arriving at our main production facility is evaluated for full documentation and compliance with our stringent raw material specifications. Raw Fetal Bovine Serum released for manufacture is then processed according to Atlanta Biologicals validated and approved manufacturing procedures, following relevant cgmp and ISO 9001 guidelines. The production process is closely monitored and documented at each stage to ensure quality and efficacy. Approved batches of raw serum are thawed under controlled conditions and transferred to our mixing tank. From there, the FBS is passed through a series of filters with an optimal combination of pore sizes by an in-line process, and filled into a pooling tank; thus creating a true pool of serum. Our filtration system uses triple 0.1 um pore-size rated filters as final filters in order to effectively remove bacteria, fungi and mycoplasma that may be present without removing critical serum components. In our positive pressure, HEPA-filtered clean room, the filtered FBS is then aseptically dispensed into gamma irradiated PET bottles. Filled containers are immediately labeled and frozen, and then stored in our temperature controlled and monitored walk-in freezers. Before the finished Fetal Bovine Serum lot is approved for distribution, it must undergo Atlanta Biologicals rigorous quality control testing procedures and meet our strict specifications and acceptance criteria. Our comprehensive basic testing performed on all grades of FBS includes performance in cell culture systems, sterility, mycoplasma, virus screening, physical analyses and biochemical assays. Through extensive testing and evaluation at every step involved in the manufacturing process, our quality control team assures that all Atlanta Biologicals Fetal Bovine Serum products meet stringent standards of quality and performance. Origin and Traceability Atlanta Biologicals understands that 100% traceability is crucial to controlling the quality and assuring the safety and integrity of every FBS lot. Direct control of the product from raw serum collection through the final filtration stage, allows us to document the serum s origins without relying on certifications from second and third hand sources. This realization has led Atlanta Biologicals to create an expanding global system of serum collection sites, allowing us to produce high quality, fully traceable FBS products while consistently meeting our customers needs even as the global supply fluctuates. The Fetal Bovine Serum used in Atlanta Biologicals manufacturing process is collected only in the US and USDA-approved countries that are documented by the United States Department of Agriculture (USDA) as being free from exotic diseases, such as FMD, Rinderpest and BSE. These origins include the United States, Central America, Mexico, Canada, Australia and New Zealand. Every lot of serum is produced meeting our stringent process controls, as well as USDA standards, and is traceable back to the place and date of collection. Serum Testing and Matching Program While our direct control and validated production processes ensure product uniformity and decreases lot-to-lot variability, natural variations in concentrations of some components in FBS can cause performance differences, particularly with sensitive cell types. Atlanta Biologicals serum testing and reserve program allows researchers to receive a sample of a serum lot to test in their own application. A specified quantity will be held on reserve until the assessment is complete, typically within 3 to 6 weeks. Alternatively, our lot matching program can select a serum lot for a certain cell culture system, based on the researcher s serum specifications and performance criteria. At Atlanta Biologicals, we are striving to assist every customer in identifying the best product for their requirements. 4

6 Fetal Bovine Sera Atlanta Biologicals The source of reliable FBS choices Our early commitment to produce Fetal Bovine Serum of extraordinary quality at exceptional value has resulted in a complete line of superior FBS products. Atlanta Biologicals manufactures a variety of Fetal Bovine Serum grades with excellent performance characteristics. Our wide selection of high quality FBS grades allows researchers to choose the best option and best value for their specific cell culture needs. Premium Select The highest grade FBS available, suitable for the most demanding and sensitive cell lines. It is also widely used when a hormone profile, an extensive biochemical profile and/or an extended virus test panel is required, in addition to comprehensive quality assurance testing. Lots are manufactured from US or USDA-approved origin material following stringent manufacturing and quality control procedures. Optima This high quality FBS product meets the requirements of most cell lines and is suitable for general applications. An extensive biochemical profile and an extended virus test panel are provided in addition to comprehensive quality assurance testing. Each lot is manufactured exclusively from US origin material following stringent manufacturing and quality control procedures. Advantage A quality FBS product at exceptional value. Especially suited where special component testing, such as the hormone assay, is not required. It is suitable for many cell culture applications, and is comprehensively tested for performance and quality assurance. Lots are manufactured from US or USDA-approved origin material following stringent manufacturing and quality control procedures. Premium A high quality FBS product that is most widely used among cell culture researchers. An extensive biochemical profile is provided in addition to comprehensive quality assurance testing. It is priced lower than FBS-Premium Select and FBS-Optima, and demonstrates superior performance with a broad spectrum of cell types. Lots are manufactured from USDA-approved origin material following stringent manufacturing and quality control procedures. Heat Inactivated Fetal Bovine Serum All of Atlanta Biologicals FBS products are also available heat inactivated. The most common objective of heat inactivation is to destroy heat-labile components such as complement that may adversely affect the growth performance of some cell cultures. Heat inactivated FBS is frequently used in immunological applications. The inactivation process involves raising the temperature to 56*C for 30 minutes under controlled conditions. Premium Select S11550 S11510 S11595 S11550H* S11510H* S11595H* Optima S12450 S12410 S12495 Premium Advantage S11150 S11110 S11195 S11050 S11010 S11095 S12450H* S12410H* S12495H* S11150H* S11110H* S11195H* S11050H* S11010H* S11095H* 5 *Heat Inactivated

7 Specialty Fetal Bovine Sera Atlanta Biologicals recognized the need for Specialty Fetal Bovine Sera (FBS) to satisfy the very specific demands that several research and industrial applications place on FBS used in cell culture systems. Due to the unique requirements of certain cell types or systems, the identification of a suitable lot of FBS is often crucial. Atlanta Biologicals qualifies FBS lots by subjecting pre-selected FBS to additional extensive testing relevant to the specific application. Similarly, many experimental systems require the use of FBS where certain components disruptive to these applications have been removed or inactivated. Atlanta Biologicals treats pre-selected FBS lots via specially developed processes designed to yield products suitable for these systems. Embryonic Stem Cell Qualified Fetal Bovine Serum For applications utilizing embryonic stem (ES) cells, the success of the research is highly dependent on identifying a suitable lot of FBS. With Atlanta Biologicals ES Qualified Fetal Bovine Serum, time consuming pre-screening of multiple serum lots is no longer required. We test our highest quality FBS lots for particular suitability for culturing embryonic stem cells. The screening includes plating efficiency, colony morphology and cytotoxicity assays. Selected lots must offer outstanding performance with embryonic stem cells while maintaining the cells in their undifferentiated state. Hybridoma Qualified Fetal Bovine Serum This serum is ideally suited for culturing hybridoma and myeloma cells. High quality Fetal Bovine Serum is screened to identify lots that offer optimal performance with these cells. Hybridoma Qualified lots must show superior growth promotion, exceptional clonal growth at limiting dilution, and a lack of cytotoxicity during the growth studies. TET Tested Fetal Bovine Serum The Tet systems are the most widely applied inducible gene expression systems. In each system, a tetracycline-controlled transactivator interacts with a responsive promoter to regulate expression of the gene of interest. Expression is controlled from outside by the effector substances tetracycline or one of its derivatives. The presence of tetracycline or its derivatives in serum may interfere with these tetracycline-regulated gene expression systems. TET Tested Fetal Bovine Serum is specifically designed for use in Tet systems and cell lines. The tetracycline and tetracycline derivative contents of high quality FBS is measured, and only lots with undetectable levels are selected as TET Tested Fetal Bovine Serum. Charcoal/Dextran Treated Fetal Bovine Serum Pre-selected high quality FBS is processed using a proprietary Charcoal/Dextran treatment proven to reduce the levels of many hormones, steroids and growth factors. Each lot produced is tested for various hormones and steroids before and after treatment to confirm the efficacy of the process. Charcoal/Dextran treated FBS is used in applications requiring lower levels of hormones, steroids or growth factors in serum, such as insulin and estrogen related research. Dialyzed Fetal Bovine Serum Dialyzed FBS is used in cell culture systems requiring a more defined environment of small mol ecules. Dialysis reduces the concentration of low molecular weight components such as nucleotides, amino acids, hormones, salts and various small proteins. Two different Dialyzed FBS products are available. The serum is dialyzed against physiological saline using either a 10,000 Dalton or a 12,000 - to 14,000 Dalton cutoff membrane. The process is controlled by precisely monitoring the glucose concentration throughout the procedure. Exhaustive dialysis is not performed in order to prevent precipitation and inactivation of serum peptides. Embryonic Stem Cell Qualified Hybridoma Qualified TET Tested Charcoal/Dextran Treated S10250 S10210 S10295 S10650 S10610 S10695 S10350 S10310 S10395 S11650 S11610 S11695 Dialyzed 10kD S12650 S12610 S12695 Dialyzed 12-14kD S12850 S12810 S12895 Gamma Irradiated S11750 S11710 S11795 S10250H* S10210H* S10295H* S10650H* S10610H* S10695H* S10350H* S10310H* S10395H* S11650H* S11610H* S11695H* S12650H* S12610H* S12695H* S12850H* S12810H* S12895H* S11750H* S11710H* S11795H* *Heat Inactivated Gamma Irradiated Fetal Bovine Serum Gamma Irradiation is recognized as an effective method of inactivating viruses and other adventi tious agents in serum. Even though FBS is stringently tested, low levels of common bovine viruses below the detection limits of current test methods may exist. Gamma Irradiated FBS is exposed to - a 60Co source at a delivered dose of kgy. Exposure of FBS to this dosage has been shown to remove up to 6 logs of many extraneous agents while preserving the growth performance character istics of serum. - 6

8 Atlanta Biologicals, Inc Industry Way Flowery Branch, GA Ph: (800) (770) (770)