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| Media, Reagents & Sera |  |
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BioWhittaker™ Classical Media
All BioWhittaker™ Classical Media products are manufactured in accordance with cGMP regulations. A Device Master Record (DMR) is prepared for every liquid medium product. It defines the procedures for production from receipt of raw materials to final product release, the environmental and processing controls required, as well as product specifications, including packaging and labeling.
Product manufacturing is consistent with the requirements defined in the DMR, which ensures that each lot of a product is consistent with all other lots of the same product. Chemicals used to prepare liquid media products are purchased according to the raw material qualifications from approved suppliers. Each lot must meet established component specifications before it is released by Quality Assurance for use.
We manufacture all liquid cell culture media using Water for Injection (WFI) quality water, which has been prepared by ultrafiltration, reverse osmosis, deionization, and distillation. Liquid media is sterile filtered through pharmaceutical-grade sterilizing filters. The formulations used for standard liquid media products are those recommended by the Tissue Culture Association. Final product testing includes USP Sterility, pH and osmolality, cell growth promotion and endotoxin content.
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BioWhittaker™ Specialty Media
Serum-free media and reagents have a wide range of applications, including production of monoclonal antibodies, viral antigens, and recombinant proteins using a variety of mammalian and invertebrate cell lines. There are numerous advantages associated with the use of serum-free media formulations. |
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Benefits:
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 | Increased definition, Increased lot-to-lot consistency |
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| Simplified purification and downstream processing |
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| Better control over the physiological condition of cultures |
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| Ability to optimize formulations for specific cell types |
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Serum-free media formulations must satisfy a number of nutritional and physical requirements of cells that are normally addressed by the presence of serum. Serum proteins, such as albumin, fibronectin, and fetuin serve a variety of functions that include adsorbing toxic compounds, providing protection against shear forces in bioreactors, creating a matrix for cellular attachment to surfaces, and acting as a carrier for lipids and other growth factors. |
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BioWhittaker™ Cell Culture Reagents
BioWhittaker™ Cell Culture Reagents include a number of different products, such as amino acids, antibiotics, and buffers, all of which are used routinely in research, and manufacturing applications involving cell culture.
These products are manufactured under the same cGMP conditions as our other cell culture products. Chemicals we use to prepare cell culture reagents are purchased according to the raw material qualifications from approved suppliers. Each lot must meet established component specifications before it is released by Quality Assurance for use.
We manufacture all liquid cell culture reagents using Water for Injection (WFI) quality water, which has been prepared by ultrafiltration, reverse osmosis, deionization, and distillation. Liquid products are sterile filtered through pharmaceutical-grade sterilizing filters.
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BioWhittaker™ Animal and Human Sera
Lonza produces a variety of sera products for use in cell culture media, production of biological and diagnostic products, and other laboratory procedures that demand the finest quality serum available. From raw material collection to final product release, in-process quality assurance tests are designed to ensure that the products we supply meet our own high quality standards as well as our clients' requirements. A Certificate of Analysis is provided for all lots produced.
All sera listed follow EC regulations on import for serum into the European community. Products manufactured using those sera might be subject to import restrictions in some countries (e.g. USA). The EC approved fetal bovine sera are manufactured in a European ISO 9001 certified facility.
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| Samples of each lot of finished product are selected and tested in accordance with written product specifications. Final product quality control includes the following: |
| Sterility: Tests are performed on representative samples using a modification of the membrane filtration method described in the European Pharmacopoeia (EP). |
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| Mycoplasma: Final Products are tested for mycoplasma using the culture test described in the EP. |
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| Adventitious Viruses: All fetal bovine serum lots receive testing for adventitious viral agents including bovine viral diarrhea (BVD), infectious bovine rhinotracheitis (IBR) and parainfluenza virus type 3 (PI3). |
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| Cell Growth Promotion: All fetal bovine serum lots are tested for their growth promoting properties. |
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