Recently, a university student from Hangzhou called our company to inquire about the serum that I purchased in our company.
Our technical explanation: heating can inactivate the complement system. Activated complement is involved in lytic cell events, stimulates smooth muscle contraction, releases histamine from cells and platelets, and activates lymphocytes and macrophages. Heat inactivated serum is recommended for immunological studies, culture of ES cells, insect cells, and smooth muscle cells.
Serum is commonly used as an additive to basic growth media in cell culture. The commonly used serum is fetal bovine serum (FBS), also known as FCS. Fetal bovine serum is collected from farms suitable for human health practices. Sometimes, other bovine serum, such as newborn bovine serum or donor bovine serum, may also be used. In cell culture, serum is supplied with abundant high molecular proteins, low molecular weight nutrients, hydrophobic carrier proteins and other essential components for cell growth in vitro such as hormones and adhesion factors. At the same time, serum can increase the buffer capacity of the medium or neutralize the toxic components to protect the cells. Whether or not serum is selected for addition during cell culture depends mainly on the chemical composition of the basal medium, the type of cultured cells, and the culture system.
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collection
In the fetal calf serum production process, all
Blood is collected using a sterile disposable plastic bag, separated after coagulation, and serum is collected and stored frozen. Controlling the initial collection of fetal bovine serum is a key factor in controlling the quality of the final serum product. Production is allowed only if the starting materials meet our specifications.
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Serum raw material
There are two fetal bovine serum standards in the global market: the US Department of Agriculture Standard (USDA) and European Standards. The US Department of Agriculture standard, the original serum must be taken from countries where there is no mad cow disease (BSE) and foot-and-mouth disease (FMD) epidemic, before it can be freely imported into any country for safe production. Moreover, researchers only use serum that meets this standard before they are allowed to send their cells and cell products to other countries that also have strict import terms for cooperation and exchange. All fetal calves processed at the BioInd plant are USDA compliant.
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Processing
Preferably, several batches of frozen serum are thawed, and the contents of endotoxin and heme are tested, and the standard can be thoroughly mixed under refrigeration to continue processing, and further filtered and sterilized. BioInd sequentially treats fetal bovine serum by pre-filtration and membrane filtration. The final filtration step was three consecutive filtrations with a 100 nm filter. At the end of the filtration, the serum is dispensed in an aseptic process, and the entire process is effective to ensure the final product is sterile. The air cleanliness of serum production is 100. All dispensing stations are filtered through a high-efficiency particulate air filter and maintained in a positive pressure dispensing environment to monitor total particulates, suspended particulates and pressure. After dispensing, the final product is quickly frozen at -20 degrees and isolated until all quality control tests are completed.
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FBS quality control
Each batch of fetal bovine serum test confirmed that it meets the standards and is recorded in the quality inspection report in writing.
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Quality assurance
The fetal bovine serum production process is carried out under a strictly controlled condition. UV sterilization, filtration sterilization and dispensing are key production steps that ensure serum quality. The data related to serum production is recorded as a special archive, from the initial collection of raw materials to the entire production process of finished product storage, as well as quality control tests and results are documented, and the source files can be traced under monitoring conditions. BioInd
The products are manufactured in accordance with the quality management standards ISO9001:2000 and ISO13485:2003, and can provide supporting documents. In addition, the fetal bovine serum production process follows the European Parliament's standards for in vitro diagnostics. Therefore, our fetal calf serum is CE marked and can be legally sold in all European countries for in vitro diagnostics. The European Medicines Quality Administration (EDQM) has issued a BSE safety certificate for BioInd, and its products have passed the European Pharmacopoeia testing standards. Producers can provide documentation in this regard.
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Recommendations
Serum as a biological material, the proportion of components is slightly different in each batch, special cell types are very sensitive to different batches of serum. Customers are advised to use their own culture system and cells to evaluate different batches of serum samples. We will reserve samples for the screening batches until the user completes the test. In this way, the user will screen out the most suitable batch according to his own requirements and ensure long-term stable use.
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