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Single-use cell culture bags used for T cells NK cells and NKT cells
The products are manufactured in a clean room in accordance with ISO 14644 CLASS 7 standard and comply with the requirements of ISO 13485:2016 medical devices quality management system, ISO 9001:2015 quality management system and GMP related regulations, and are strictly controlled in all aspects from design and development, material selection, manufacturing to finished product inspection and release. Our products have established corporate standards according to USP, FDA, ISO, ASTM, Chp, Ep, YBB, etc. and are verified by qualified third-party testing laboratories, and the verification results are in compliance with Chp, YBB, USP<661>, USP<665>, USP<85>, USP87>, USP<88> Class Vl, USP<788>, ISO<1099>, and ISO<1099>. 788>, ISO<10993>SO<11137>, ASTM 1980-16, FDA CFR 177.2600, European Pharmacopoeia 3.1.9 standard requirements. We can provide complete system validation documents and technical support services to meet the needs of drug registration.
Single-use bags for bioprocess, commonly known as single-use bioreactor bags, are specialized containers designed for the cultivation of cells or microorganisms in bioprocessing applications. These bags are used in the production of biopharmaceuticals, vaccines, and other biologically derived products. The term "single-use" implies that these bags are disposable after a single batch or use, reducing the risk of cross-contamination and eliminating the need for extensive cleaning and sterilization processes associated with traditional stainless-steel bioreactors.
Key Features of Single-Use Bags for Biological Processes:
Material Compatibility: The bags are typically made from biocompatible and sterile materials such as polyethylene or other polymers that do not interfere with the growth of cells or the production of biological products.
Sterility: Single-use bags must maintain a high level of sterility to ensure the integrity of the biological process. They are often gamma-irradiated or treated with other methods to achieve and maintain sterility.
Scalability: Single-use bioreactor bags come in various sizes to accommodate different volumes, allowing for scalability in bioprocessing operations.
Ports and Connectors: These bags include ports for the addition of nutrients, sampling, and harvesting of the cultured cells or products. The bags are equipped with connectors for integration with other components of the bioprocessing system.
Mixing Systems: Some single-use bioreactor bags come with integrated mixing systems, such as magnetic stirrers or rocking motion, to ensure homogenous cell growth and product expression.
Advantages:
Reduced Cleaning Validation: Eliminates the need for extensive cleaning and validation processes associated with traditional stainless-steel bioreactors.
Flexibility: Allows for quick and easy changeovers between different batches or products.
Cost-Efficiency: Reduces capital and operating costs associated with cleaning, sterilization, and maintenance of traditional bioreactors.
Minimized Cross-Contamination Risk: With single-use bags, the risk of cross-contamination between batches is significantly reduced.
Applications:
Single-use bags for biological processes are used in a variety of bioprocessing applications, including:
Biopharmaceutical Production: Cultivation of mammalian cells for the production of monoclonal antibodies, recombinant proteins, and other biopharmaceuticals.
Vaccine Production: Growth of virus or bacteria cultures for vaccine production.
Stem Cell Culture: Expansion and cultivation of stem cells for regenerative medicine applications.
Microbial Fermentation: Cultivation of microorganisms for the production of enzymes, antibiotics, and other microbial-derived products.
The single-use bags for biological processes provide a flexible and cost-effective solution for bioprocessing applications, offering advantages in terms of scalability, sterility, and minimizing the risk of cross-contamination.
Cell culture bag introduction：
· Culture bag is a cell culture container made of a special waterproof breathable membrane that can support high-density growth.
· Suitable for suspension cell culture.
· It is a one-way closed system that effectively reduces the risk of contamination and is sterile after irradiation sterilization.
· The cell culture bag has good permeability and can deliver a high degree of oxygen to the cells in culture.
Cell culture bag application：
At present, it is mainly used for the culture of human lymphocytes such as T cells, NK cells and NKT cells.
Cell culture bag characteristic：
· High permeability: The use of three layers of breathable material construction, with very high permeability to oxygen/carbon dioxide can greatly increase the number of cell culture.
· High transparency: the plastic film has high transparency, and the cell morphology can be clearly observed under the microscope.
· High fertility: to meet the needs of large-scale expansion and culture of various suspended cells such as lymphocytes.
· High strength: thickness 100um, with enough toughness, so that the operation of cell culture is more secure.
· Prevent contamination: sealed environment, reduce sample contamination, sterility, mycoplasma free, low endotoxin
· Reasonable structure: the shape of the internal liquid storage is circular without dead corners, which is conducive to maximum cell collection.
· Easy to use: the length of 50cm liquid filling pipe is used, which is more convenient for liquid perfusion and discharge operation; The use of coarse rehydration tube to speed up the flow of culture fluid and improve work efficiency.
· Material safety: does not contain substances such as plasticizers, exudates, and dissolved substances that have an impact on cell culture; In line with the standards of Chinese Pharmacopoeia resin pharmaceutical containers.
We provide various customized services (OEM&ODM) to global buyers, informing us of the requirements for bioprocess single use bags or other equipment, such as pipeline materials, length, diameter, clamp types, usage or photos of the products currently in use. You can also inquire with us based on the standard model numbers listed below.
Partial products categories: Bioprocess single-use bags, Atomic absorption spectrometer(AAS), Ultraviolet and Visible spectrophotometer(UV-VIS Spectrophotometer) , Life science instruments, Heating instruments, etc.
We look forward to more communication with you. Please contact us for inquiry：info@newmeen.com
