General Questions

• What makes Biowest a specialist in cell culture?

  With over 35 years of experience in serum as its main activity, Biowest stands out by being dedicated to quality and service. Thanks to its vertical integration, the company offers the widest range of origins in the world, making it an essential specialist in cell culture.

  Thanks to its expertise, Biowest collaborates closely with research laboratories, academic institutions, and pharmaceutical companies worldwide. By providing high-quality culture media, tailored to the specific needs of each project, Biowest plays a fundamental role in scientific discoveries, clinical trials, and the development of new therapies.

  Biowest distinguishes itself through its commitment to a vertically integrated supply chain, meeting the highest standards in terms of quality, traceability, and safety. In 2004, the company was acquired by the Serascandia group, thus becoming the first vertically integrated serum company.

  That same year, Biowest reported cases of false declaration to the authorities and informed the concerned parties. It emphasized the importance of directives and traceability monitoring in the serum industry, while encouraging the creation of the ISIA (International Serum Industry Association) and the ESPA (European Serum Producers Association). This action demonstrates Biowest’s commitment to professional ethics and its willingness to promote responsible practices within the serum industry.

• Why select Biowest as a serum supplier?

  Biowest guarantees a high level of quality, traceability, and biosecurity, notably through an ISO 9001 certification obtained in 2006 and revalidated every 3 years by an accredited body, comprehensive documentation, and supplier audits involved throughout the entire production process.

• What does the term ESPA mean?

  ESPA is the European Serum Producers Association. Its objective is to promote the use of serum, harmonize regulations, connect companies in the serum processing industry in EU and non-EU countries, and represent their interests.
  Find more information on this link: https://serumproducts.eu/

• What is the OIE (World Organisation for Animal Health)?

  The OIE (World Organisation for Animal Health) is an intergovernmental organization created in 1924.
  In 2011, the OIE had 178 member countries and territories.

  Its missions are:

  • to ensure the transparency of the global animal disease situation
  • to collect, analyze, and disseminate veterinary scientific information
  • to provide expertise and encourage international solidarity in the fight against animal diseases
  • to safeguard world trade by publishing sanitary standards for the international trade of animals and products of animal origin
  • to improve the legal framework and resources of national veterinary services organizations.

• Why is traceability important, and how is it guaranteed by Biowest?

  Traceability is essential because it provides a chain of product identity from the country and slaughterhouse of origin to the production, packaging, and labeling sites, ready for final sale and distribution. This traceability ensures that our products comply with regulations at every stage of the process, thus offering total transparency and absolute conformity.

  At Biowest, we guarantee traceability by implementing a rigorous monitoring system throughout the entire production process. We meticulously record and manage information concerning the product’s origin, production conditions, transformation steps, and quality controls. Biowest is proud to maintain an uninterrupted production chain.

  Thanks to our commitment to traceability, we are proud to maintain an uninterrupted chain of information, making it possible to guarantee the origin and quality of our products.

• Are Biowest products sterile?

  Unless otherwise indicated on the product labels, Biowest sera and liquid media are sterile filtered. Sterility is not guaranteed after opening. The use of aseptic handling techniques is recommended. Sampling for sterility tests of all Biowest products complies with the requirements of the European Pharmacopoeia.

• What about animal welfare and ethics?

  Biowest attaches particular importance to animal welfare. The process for producing animal sera complies with the animal welfare principles established by the OIE – World Organisation for Animal Health, Terrestrial Animal Health Code 2012, Volume I, section 7.
  Concerning Fetal Bovine Serum (FBS), Biowest uses only blood collected as a by-product of cows slaughtered for human consumption.

  In order to guarantee ethical production of this serum, we have implemented collection procedures that eliminate any risk of causing any pain to the fetus. Fetal Bovine blood is only collected in the absence of vital signs from the fetus (OIE – Terrestrial Animal Health Code 2012, Volume I, Article 7.5.5.).

Fetal Bovine Serum (FBS)

• What is FBS?

  Serum is the liquid component extracted from clotted whole blood after centrifugation. It is obtained from the blood of the fetal calf, collected aseptically within the slaughterhouse. Fetal Bovine Serum is a widely used and necessary product for the culture of many cell lines, as it provides numerous nutrients and allows cells to proliferate in vitro. Fetal Bovine blood is only collected in the absence of vital signs from the fetus

• How is FBS used?

  In vitro cells need a nutritive medium or culture medium to grow. It is composed of a base medium and supplements. Fetal Bovine Serum is added as a supplement to the cell culture medium, generally at a concentration of 10%.

• For which applications is FBS used?

  There is a wide range of applications for Fetal Bovine Serum. The most important is in the field of biopharmaceutical products and vaccines. It is used in the research, manufacturing, and control of human and veterinary vaccines and medicines, many of which are at the forefront of development.

  Fetal Bovine Serum is also widely used in research.

• Are there alternatives to FBS?

  Serum-free alternatives exist, such as FreeAdd (ref: S6010). Since each cell type has different requirements, their use can be complex and costly.

• How to select FBS for stem cells?

  In order to select a high-performing FBS for stem cell culture, Biowest recommends testing different lots on your cell lines. Biowest offers qualified FBS lots for stem cell culture (ref: S181S). Dr. Yamanaka, Nobel Prize laureate related to stem cell research, selected one of our Biowest FBS lots for his various tests.

• How is FBS obtained?

  Fetal Bovine Serum is obtained from the clotted and centrifuged blood of the fetal calf, collected aseptically within the slaughterhouse. Fetal blood is collected from the fetuses of pregnant cows, slaughtered in accordance with the OIE (World Organisation for Animal Health) directives and internationally recognized veterinary inspection standards. Fetal Bovine blood is only collected in the absence of vital signs from the fetus

• Can the origin of serum have an impact on its quality?

  The origin of the serum has no influence on cell growth. Biowest compared cell growth in FBS from seven different countries across three continents, and confirmed that, regardless of the country of origin, all cell lines tested had the same average performance.

  An FBS lot may give good results for a specific cell line, but not for another. The “serum quality” is specific to each cell line. This is why FBS testing is widely used when dealing with sensitive cell lines. Biowest performs the most comprehensive analysis of biochemical parameters and tests on the sector’s cell lines, and makes the results available on the certificates of analysis.

• Why is FBS less expensive in Europe than in the United States?

  It is a question of FBS importation, which is less restricted in Europe than in the United States. The International Serum Industry Association (ISIA) supports efforts to harmonize import rules, thus suggesting compliance with OIE recommendations. In the meantime, FBS in the United States remains more than twice as expensive as in Europe.

• Why is the demand for FBS increasing?

  The demand for FBS is increasing in parallel with the latest research developments, particularly stem cells, cell therapy, new vaccines, and proteomics.

• Why is the demand for FBS increasing?

  The demand for FBS is increasing in parallel with the latest research developments, particularly stem cells, cell therapy, new vaccines, and proteomics.

• What is the impact of the presence of tetracyclines in FBS?

  Tetracyclines are a family of broad-spectrum antibiotics that inhibit bacterial protein synthesis by blocking the binding of aminoacyl-tRNA to the ribosome. Due to growing concerns regarding the development of antibiotic-resistant microbes, the use of tetracycline as a growth promoter was banned in the EU in the early 1970s. However, in the rest of the world, tetracycline is still among the most frequently used antibiotics in livestock farming.

  Since 1992, the tetracycline-controlled transcriptional activation system has been used for the induction (Tet-on) or inhibition (Tet-off) of the expression of certain genes in cell line or animal models. Both systems are very sensitive to tetracycline, even in small amounts, present in the FBS. The use of tetracycline-free FBS makes it possible to control the induction of these systems in your different applications.

  Please contact your Biowest representative for more information or to help you select the lot best suited to your tetracycline-sensitive application.

Cell Culture Media

• What is Cell Culture?

  Cell culture, or in vitro culture, corresponds to the set of techniques allowing animal cells, mainly, to be maintained outside of their original tissue environment under controlled survival conditions.

• What is a Culture Medium?

  A cell culture medium is a medium in which all the elements necessary for cell survival and growth are found. It is composed of a base medium, a complex mixture of mineral salts, carbohydrates, vitamins, amino acids, metabolic precursors, growth factors, hormones, and oligo-elements, and supplements, such as FBS.

• Why is serum necessary in Cell Culture?

  Serum, particularly Fetal Bovine Serum, is a product very rich in proteins, oligo-elements, as well as growth factors enabling cell proliferation. It also contains attachment factors creating a “coating” effect on the support plastic, thus increasing cell adherence. It is an essential product in cell culture due to the various components it provides.

Cell Culture Reagents

• Is it normal for Trypsin products to not always have the same color?

  Certain trypsin preparations contain phenol red. Since the product is shipped with dry ice, there may be a significant accumulation of CO2 in the packaging.

  This CO2 can penetrate the solution and slightly lower the pH, giving an orange color (around pH 6.5) or a reddish-pink color (around 7.3). The solution, if it is orange (acidic), can still be good to use as is, or sodium hydroxide can be added to adjust the pH.

• What is the difference between L-Glutamine and stabilized Glutamine?

  L-glutamine, an essential amino acid for cellular metabolism, is the natural and classic form of glutamine. Its drawback is its very high thermosensitivity, making it easily degradable under cell culture conditions. Stabilized glutamine, such as the dipeptide L-alanyl-L-glutamine, is modified to be much more stable, which allows for generally superior efficacy. Note that certain cell types are not capable of using modified L-Glutamine.

Basal Medium

• What is the composition of a base medium?

  A base medium is composed of nutrients for the cell, such as mineral salts, amino acids, or carbohydrates, and elements allowing the maintenance of pH and osmolality (buffer solutions, phenol red).

• What is the purpose of a base medium in cell culture?

  A base medium provides certain nutrients necessary for cell survival and growth, such as amino acids and carbohydrates. It also makes it possible to maintain osmolality and pH at a physiological level.

• At what temperature should a base medium be stored?

  Base media are generally stored at +4°C/+8°C away from light.

• How long can a base medium be stored?

  An unopened base medium can be stored until the expiration date indicated on the bottle and the CoA at +4°C/+8°C. Once opened, the base medium is stable for two weeks.

• Why is the base medium red/pink?

  Base media generally contain a pH indicator, phenol red. This component turns yellow when the medium becomes acidic and fuchsia pink when the pH is basic.

Serum

• What is the role of serum in cell culture?

  Serum, due to its rich composition of proteins, oligo-elements, and growth factors, provides all the necessary nutrients and components for the survival, proliferation, and growth of cells.

• What is the best way to thaw serum?

  Serum is thawed at +2°C/+8°C to prevent any degradation of mitogenic factors. It can also be thawed at room temperature by periodically shaking to resuspend the contents. Temperatures above 37°C can compromise the serum’s performance by accelerating the degradation of critical serum factors, and should be avoided in the laboratory. Thawed serum must be carefully mixed before being added to the cell culture medium.

• What do the precipitates observed in serum correspond to?

  After thawing the serum, precipitates and turbidity may appear. These are fibrin precipitates.
  If the serum is incubated at 37°C for a prolonged period, calcium phosphate precipitates may appear, in addition to those of fibrin.
  In both cases, to our knowledge, this does not alter the performance of the serum in cell culture.

• What is the detailed protocol for serum inactivation?

  Serum is heat-inactivated by the action of heat. This allows for the inactivation of complement factors present in the serum. During heat inactivation, the product temperature is monitored using a control vial, in addition to the vial intended for cell culture. The vials are thawed at +2°C/+8°C, then placed in a water bath at +80°C. When the temperature of the control vial reaches +50°C, set the water bath thermostat to +70°C.
  Then, when the vial temperature reaches +55°C, lower the thermostat to +60°C. When the temperature of the control vial is at +56°C, set the thermostat to +56°C and allow to incubate for 30 minutes. Stir the vial to be heat-inactivated every 5 to 10 minutes. Check the temperature regularly. Maintain the temperature at +56°C by adjusting the thermostat, adding cold water, or using the lid. After incubation, allow the serum to cool to room temperature for 30 minutes, then freeze it at -20°C.

  Note: Agitation is crucial for the good quality of the serum. If the serum is not properly mixed, a precipitate of salts, proteins, and lipids will appear, which can give the serum a gelled appearance. These deposits are not toxic to cell culture but affect the serum’s appearance and consistency. Incubating the serum at +56°C for more than 30 minutes can deteriorate serum growth factors, thereby decreasing the serum’s performance.

• How long can serum be stored between +2°C and +8°C?

  Serum can be stored between +2°C/+8°C for up to 8 weeks without its performance being diminished (*).

  (*) Art to Science, Vol.19, No.2, “Serum Stability at Refrigerated Temperatures (2-8C)

• What is the recommended storage temperature for serum?

  Serum should be stored frozen at -20°C (-10°C/-40°C) and protected from light. If stored at temperatures below -40°C, the vials can become fragile, increasing the risk of breakage.

• Is there a difference between the different origins of serum?

  High-quality serum can come from any country, provided it is collected, imported, and processed in compliance with all applicable regulatory and industrial requirements. No continent or country producing FBS has an inherent advantage, in terms of quality, compared to other origins.

• What is the impact of a country's foot-and-mouth disease (FMD) health status on serum?

  Foot-and-mouth disease is relevant for regulatory import purposes, but has no impact on cell growth. A few countries, including the United States, only authorize imports of FBS from FMD-free countries without vaccination; while most other countries accept FMD-free countries with vaccination.

  Foot-and-mouth disease is endemic in parts of Asia and most of Africa and the Middle East. The majority of Latin American countries have implemented zoning measures and are recognized as being free of FMD with or without vaccination.

  Australia, New Zealand, and Indonesia, Central America, North America, and Western Europe are currently free of FMD. However, it is a transboundary disease that can occur sporadically in zones usually free of the disease. (https://www.woah.org/fr/maladie/fievre-aphteuse/)

• What are TSE/BSE and what are the associated risks?

  Transmissible Spongiform Encephalopathies (TSEs) are chronic neurodegenerative diseases characterized by the accumulation of an abnormal isoform of a cellular glycoprotein (named PrP or prion protein). Animal TSEs include, among others, Bovine Spongiform Encephalopathy (BSE) in cattle and scrapie in sheep and goats.

  Cattle, sheep, goats, and animals naturally susceptible to infection by TSE agents or animals susceptible to oral infection other than human or non-human primates (cervids, mink, felids, exotic ungulates) are defined as “animal species of concern regarding TSEs”. Pigs and birds, animal species of particular interest for the production of medicinal products, are not susceptible to natural oral infection.

  (Excerpt from “Explanatory note concerning the reduction of the risk of transmission of animal spongiform encephalopathy agents by medicinal products for human and veterinary use (EMA/410/01 rev. 3)”)

  According to the OIE (World Organisation for Animal Health), there is no risk of BSE transmission in several products, such as milk, hides and skins, deboned meat, blood and blood by-products, such as Fetal Bovine Serum (OIE Terrestrial Code 11.4 BSE). Most OIE member countries have adopted this position, including the European Union and the United States (USDA).

• Why not use the PCR test for viruses?

  A simple PCR test allows for the detection of DNA and RNA from live or dead viruses. The PCR test must be combined with cell culture tests to detect live viruses.

• Why is serum sometimes irradiated? What are the impacts on its performance?

  Gamma ray irradiation makes it possible to eliminate any potential risk of viruses, bacteria, and fungi that may be present in the serum. Irradiation does not induce any modification of the biochemical composition or significant decrease in product performance. However, the serum may have a darker appearance than non-irradiated serum. Biowest suggests testing this serum beforehand on your different applications.

  Biowest also offers a superior quality Biopharm FBS, certified free of 9 major bovine viruses.

Other Sera

• What is Bovine Serum?

  Serum is the liquid component extracted from clotted or defibrinated whole blood after centrifugation. It is obtained from the blood of domestic cattle, collected within the slaughterhouse under tightly controlled conditions. The process has been carefully developed and uses sophisticated facilities and equipment. It is accompanied by in-depth testing, particularly rigorous when the processed bovine serum is intended for use in the production of medicinal products.

• Where does Bovine Serum come from?

  Bovine Serum is a by-product of the meat industry. It can be collected at the time of slaughter from adult cattle, calves, or very young calves. It is also obtained from living animals known as “donors” who donate their blood more than once.

• How is Bovine Serum tested for viruses?

  Biowest tests the serum for viruses (BVD, IBR, PI3) using a cell culture method, in order to detect the presence or absence of live virus in the serum.

• Why choose blood group AB for Human Serum?

  Human Serum from AB-type donors is deficient in antibodies against blood group A and B antigens. It therefore minimizes immunoreactivity, since most human serum users work with cells of the immune system.

Origin and Traceability

• What makes Biowest a specialist in cell culture?

  With over 35 years of experience in serum as its main activity, Biowest stands out by being dedicated to quality and service. Thanks to its vertical integration, the company offers the widest range of origins in the world, making it an essential specialist in cell culture.

  Thanks to its expertise, Biowest collaborates closely with research laboratories, academic institutions, and pharmaceutical companies worldwide. By providing high-quality culture media, tailored to the specific needs of each project, Biowest plays a fundamental role in scientific discoveries, clinical trials, and the development of new therapies.

  Biowest distinguishes itself through its commitment to a vertically integrated supply chain, meeting the highest standards in terms of quality, traceability, and safety. In 2004, the company was acquired by the Serascandia group, thus becoming the first vertically integrated serum company.

  That same year, Biowest reported cases of false declaration to the authorities and informed the concerned parties. It emphasized the importance of directives and traceability monitoring in the serum industry, while encouraging the creation of the ISIA (International Serum Industry Association) and the ESPA (European Serum Producers Association). This action demonstrates Biowest’s commitment to professional ethics and its willingness to promote responsible practices within the serum industry.

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