As the earliest commercialized animal cell culture company, GIBCO still maintains its leading position in this field. We can provide the widest variety to meet the different needs of users (please refer to our catalog for detailed information on culture medium products), and each product has passed the most stringent quality management. At the same time, we can also modify the medium formula according to the requirements of customers, or produce according to the customer's formula.
In terms of the dosage form of the culture medium, we can provide the traditional dry powder dosage form, which is conducive to long-term storage and saves storage space; at the same time, it can also provide a liquid dosage form of working concentration, so you can save a lot of time and labor Reduce the difference between each batch of culture medium caused by human factors; in addition, our original 10 times and 50 times concentrated liquid medium combines the advantages of the above two dosage forms.
In terms of packaging, dry powdered media are usually available in packages of 10 × 1L, 10L, and 50L, and liquid media are usually packaged in 100ml, 500ml, and 1000ml to suit users of different scales of use. The liquid culture medium is packed in our patented EZ HOLD plastic bottle, which is convenient and safe.
More importantly, GIBCO constantly improves the quality of the culture medium. GIBCO's dry powder culture gene has an ultra-fine grinding particle size to ensure the best solubility in similar products.
Advanced Particle Technology (AGT)
AGT is a dry powder cell culture medium using a new particle form, which is most suitable for research and large-scale production applications. By applying the fluid bed granulation technology of mature drug production to cell culture media, we can now provide modern, high-complex formulations that are easy to use.
AGT is a complete and pH adjusted medium. The main advantage of this medium is to provide users with a raw material, which can reduce the cost and time associated with raw material planning, processing and inspection. Since the AGT medium is a complete medium and pH adjustment is not required, the preparation time of the medium is also shortened. In addition, since the particles are rapidly hydrated and easily dissolved, the total medium preparation time is reduced.
Production of culture medium and preparation of liquid medium water The distilled water used to prepare the liquid medium meets all the requirements of the US Pharmacopoeia for water for injection, including pretreatment before distillation. The pure water obtained by distillation is transported to the place of use through a completely closed pipeline, and cooled to the preparation temperature through a heat exchanger. All pipes in the process of distillation, storage and transportation are constructed with sterilized 316 low carbon stainless steel. The entire system is automatically controlled by a microprocessor using the latest sensing and alarm devices. Continuous online testing ensures that various indicators meet the requirements of the US Pharmacopoeia.
Processing of chemicals All raw materials for chemicals used in liquid culture media are subjected to strict quality control tests to ensure that the quality of our final products meets standards. These chemicals comply with ACS and FCC standards. When there are no existing standards, our internal standards are used. It has been confirmed that high-quality chemicals are accurately weighed, checked, and dissolved in distilled water in a calibrated preparation tank.
Membrane filtration
GIBCO cell culture medium is sterile filtered in a facility that meets industry sterility standards of Class 1000. The highest sterility standard is 1000000, which is difficult to achieve without terminal sterilization. The key to controlling sterility is effective sterilization procedures for all materials in contact with the product, comprehensive environmental monitoring procedures, and overall inspection procedures for final filtration. In addition, filtering and packaging under positive pressure conditions, HEPA filtration, and environmental control are also important factors. The canned culture medium undergoes rigorous quality inspection until the quality control report is completed, and the quality of the culture medium is confirmed to meet our standards before it can be shipped.
Dry powder medium All chemical raw materials used in dry powder medium have undergone strict quality control tests to ensure that the quality of our final products meets the standards. These chemicals comply with ACS and FCC standards. When there are no existing standards, our internal standards are used.
QC
In order to ensure the continued effectiveness of our validation system and control, liquid culture media is tested with samples from each batch to determine the quality of the liquid culture media.
Chemical testing detects osmotic pressure and pH to verify compliance with product specifications.
Microbiological testing confirms that there is no contamination of bacteria and fungi in the liquid culture medium by referring to the method used in the current edition of the US Pharmacopoeia Aseptic Testing Monograph. At the same time, the use of Barile and Kern large-volume inoculation detection methods to confirm that there is no mycoplasma in products of animal origin. For details of these tests, please refer to the chapter "Microbiological testing" in the animal serum section.
Growth performance and toxicity test The growth promotion effect of liquid culture medium without cytotoxicity and suspension culture analysis was tested. The rapidly growing murine myeloma cell line Sp2 / O-Ag14 was inoculated into the medium at a density of 5x10 cells / ml, and the growth rate was compared with the culture grown in the standard control medium by monitoring the logarithmic growth rate. The performance of special culture media is tested using appropriate cell lines and compared with recognized reference standards.
Endotoxin testing uses the Limulus Amebocyte Lysate (LAL) test to detect endotoxin values. Media with the lowest levels of endotoxin available in the industry are usually available.
The stability test program shows the validity period of each product marked for in vitro diagnosis, which shows how long this product has efficacy. Our stability program determines and proves the product's expiration date. Periodic gaps monitor batches of products to determine the length of time the products have acceptable results under recommended storage conditions.
The dry powder culture medium evaluates the samples from each batch in accordance with the specifications, and the quality of the dry powder culture medium has been determined. Prepare 1x liquid form samples, membrane filtration, monitoring may include:
â— Growth promotion / toxicity â— Solubility â— Osmotic pressure â— pH value Determine the value of these parameters by passing the liquid medium test conditions. All dry powder media does not contain sodium bicarbonate to increase its stability
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