An Optimal Way to Protect Critical Cell Cultures

Intended Use: The OriGen Biomedical® PermaLife bag is intended for use in cell culture and in protecting, storing, and freezing cells and tissues.

Registration

FDA 510(k) Cleared. CE Marked.

OriGen Biomedical sells directly and works with a network of global distributors. For availability in your country, please contact us below.

  • User Inspired Design

    A sterile, needle-free, luer-actuated adapter is attached to most bag configurations. This self-sealing valve makes it easy to feed and harvest sensitive cells.

  • Gas Permeable – Water Impermeable

    Fluoroethyl polymer (FEP) film is gas permeable and gas transfer rates for oxygen, carbon dioxide and nitrogen are well-established. However, FEP film is practically impermeable to water so water losses from the cell culture are negligible.

  • Observe Your Culture

    The PermaLife bag is transparent, allowing observation of the cell culture under a microscope without risking contamination of the culture.

  • Inert

    FEP film has no plasticizers, is chemically inert, and is biologically safe for the intended use so the bag will not alter the culture or the medium.

ML27.R08

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Product Use

Product Code

Description

Working Volume, ml

Width, cm

Length, cm

Packaging

 

PL07-2G One NFV port 10 3 6.4 Pouch of 1  
PL30-2G One NFV port and one port with female luer lock with cap 40 8.9 6.1 Pouch of 1  
PL30T One port with 15cm sealed SCD tubing and one port with 15cm SCD tubing with micron porous luer plug 40 8.9 6.1 Pouch of 1  
PL70-2G One NFV port and one port with female luer lock with cap 100 8.9 9.7 Pouch of 1  
PL120-2G One NFV port and one port with female luer lock with cap 150 8.9 14 Pouch of 1  
PL120T One port with 15cm sealed SCD tubing and one port with 15cm SCD tubing with micron porous luer plug 150 8.9 14 Pouch of 1  
PL240-2G One NFV port and one port with female luer lock with cap 300 14 19.3 Pouch of 1  
PL240T One port with 15cm sealed SCD tubing and one port with 15cm SCD tubing with micron porous luer plug 300 14 19.3 Pouch of 1  
PL325-2G One NFV port and one port with female luer lock with cap 450 14 25.9 Pouch of 1  
PL325T One port with 15cm sealed SCD tubing and one port with 15cm SCD tubing with micron porous luer plug 450 14 25.9 Pouch of 1  
PL500P-2G One NFV port and one PVC spike port, packed with additional PVC spike port, on hanging rod 750 29.2 18 Pouch of 1

Special Order

PL750-2G One NFV port and one port with female luer lock with cap, on hanging rod 1000 29.2 26.4 Pouch of 1  
PL750T One port with 15cm sealed SCD tubing and one port with 15cm SCD tubing with micron porous luer plug, on hanging rod 1000 29.2 26.4 Pouch of 1  
PL1000P-2G One NFV port and one PVC spike port, packed with additional PVC spike port, on hanging rod 1500 29.2 35 Pouch of 1  
PL2000P2-2G One NFV port and one port with 30cm sealed SCD tubing, packed with additional NFV cover, on hanging rod 3000 45 45.7 Pouch of 1  

Best viewed on a desktop or laptop computer.

In cell culture - what is the benefit of using a closed system?

Bags create a closed system that reduces the possibility of contamination. Swabbable needle-free valves are provided that provide repeated sterile access (and prevent needle sticks). Our cell culture bags have a high optical transmission that allows for the inspection of contents without risking contamination of the culture. The bags are gas-permeable and provide high rates of oxygen transfer to cells under culture. Additionally, water permeability is very low, so water loss is negligible and humidified incubators are not required.

What are the dimensions of a particular PermaLife Bag?

All sizing information can be found on the product brochure.

How can I handle my PermaLife products to help prevent undesired outcomes from occurring during use?

Please download our Handling Guidelines for Optimum Use When Using Your OriGen Biomedical PermaLife Cell Culture Bag here.

What is the expiration date of PermaLife Products?

4 years from sterilization

I have a problem with a product, what is the complaint procedure?

If you encounter any issues with an OriGen Biomedical product and wish to file a complaint, we encourage you to do so ASAP. Please contact the OriGen head office or reach out to your dedicated sales representative for assistance. To facilitate our investigation and resolution process, we kindly ask that you retain both the product and its packaging. This will aid us in conducting a thorough analysis of the matter. All complaints will be acknowledged, and OriGen will follow up as appropriate during the investigation. Your feedback is invaluable to us as we strive to maintain the highest standards of quality and customer satisfaction.

Where can I find the Instructions for Use (IFU), Certificate of Analysis (CoA), Certificate of Conformance (CoC), and/or Safety Data Sheet (SDS) for the product I received?

OriGen has transitioned to using Electronic Instructions for Use (eIFUs). They are available at ifu.origen.com. Your CoA or CoC will be included with your original shipment box and can also be accessed through the Client Login. If you do not have a current Client Login, you will need to register for an account to access these documents.

How do I report an adverse event?

Any adverse event related to the device should immediately be reported to OriGen Biomedical or its authorized distributor, the competent local authority, and any other regulators as required by telephone, fax, or letter. This includes an incident or risk of a serious incident liable to result in, or to have resulted in, the death or serious deterioration in the health condition of a patient or user. All complaints should be accompanied by the name(s), reference(s), and batch number(s) of the component(s) and the name and address of the claimant, the nature of the complaint with as much detail as possible, and the indication of a requested response. OriGen Biomedical is located at 2215 Grand Avenue Parkway, Austin, TX, USA 78728-3812 (Tel: +1-512-474-7278, Email: sales.us@origen.com).

What do the product codes mean?

Please see our product code definitions located here.

What is the maximum fill volume for each bag?

The working volume is the maximum volume we recommend for PermaLife products when performing cell culture. Any volume up to the maximum working volume would be acceptable. We do not establish a minimum volume for the product and recommend that the ideal volume for a customer’s cell culture be determined by the user.

Can PermaLife Bags be centrifuged?

OriGen has not validated the use of PermaLife bags in centrifuges.

Can PermaLife Bags be put in an incubator?

Yes, PermaLife bags can be used with most dry incubators.

How do I obtain pricing?

Please contact your OriGen Account Manager (USA, Canada, or UK), your local distributor (international), or OriGen Biomedical if you are unsure of who to contact through the form here or by calling +1-512-474-7278.

What are OriGen's lead times?

When available, most orders ship within 2-3 business days. Some international orders may take 3-5 business days for shipment. Special order items will always be manufactured to order, with minimum quantities and a lead time.

Are PermaLife bags designed to be frozen inside liquid nitrogen, gas phase, or both?

PermaLife bags are validated to maintain integrity in direct liquid nitrogen and are therefore able to be frozen at temperatures found in both in liquid and in vapor phases. Please follow institutional protocols to determine the phase of nitrogen that best suits your needs.

What applications could PermaLife Cell Culture Bags be used in?

OriGen does not indicate the PermaLife bags for specific applications. The patient group is not a factor in the clinical use of the CryoStore Freezing Bags as the products are not intended for use with any specific patient population, disease state, clinical stage of disease, nor patient condition. Our existing customers commonly use the PermaLife bags for:
• Biopharmaceutical Production
• Stem Cell Expansion and Differentiation
• Vaccine Development
• Drug Discovery and Screening
• Cell Therapy Manufacturing
• Virology Research
• Tissue Engineering

What is the recommended storage for PermaLife Bags?

Store in a cool, dry area (typically 15°C – 30°C), but users should define and validate their specific space and assign ranges suitable for their conditions.

What is the difference between the PermaLife Bags and PermaLife T-Set Bags?

Permalife T Set Bags have 30cm of tubing for SDC welding and do not have a needle-free valve.

How can I remove air bubbles from the PermaLife Bag?

OriGen recommends connecting a syringe to the needle-free valve to remove the air from the bags. Customers can gently manipulate and massage the bag to move the air to the top of the bag near the ports. The bag may need to be tilted to get the air to move near the port and then the user can pull out the air using the syringe.

Song, H., Procházková, M., Shao, L., Traynor, R., Underwood, S., Black, M. A., Fellowes, V., Shi, R., Pouzolles, M., Chou, H., Cheuk, A., Taylor, N., Jin, P., Somerville, R., Stroncek, D. F., Khan, J., & Highfill, S. L. (2024). CAR-T cell expansion platforms yield distinct T cell differentiation states. Cytotherapy. 2024. DOI: https://doi.org/10.1016/j.jcyt.2024.03.003.

Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6. PMID: 36536403; PMCID: PMC9764707.

Tirado-Gonzalez I, Descot A, Soetopo D, et al. AXL Inhibition in Macrophages Stimulates Host-versus-Leukemia Immunity and Eradicates Naïve and Treatment-Resistant Leukemia. Cancer Discovery. 2021 Nov;11(11):2924-2943. DOI: 10.1158/2159-8290.cd-20-1378. PMID: 34103328; PMCID: PMC7611942.

Niesel, K. A. The influence of radio-immunotherapy on the tumor microenvironment of breast-to-brain metastasis and the investigation of novel adjuvant therapies. 2021. TU Darmstadt. https://doi.org/10.26083/tuprints-00018577

Zhang J, Müller BSF, Tyre KN, et al. Competitive Growth Assay of Mutagenized Chlamydomonas reinhardtii Compatible With the International Space Station Veggie Plant Growth Chamber. Frontiers in Plant Science. 2020 ;11:631. DOI: 10.3389/fpls.2020.00631. PMID: 32523594; PMCID: PMC7261848.

Nelson RC, Fellowes V, Jin P, et al. Group O plasma as a media supplement for CAR-T cells and other adoptive T-cell therapies. Transfusion. 2020 May;60(5):1004-1014. DOI: 10.1111/trf.15745. PMID: 32167176; PMCID: PMC8404615.

Klemm F, Maas RR, Bowman RL, et al. Interrogation of the Microenvironmental Landscape in Brain Tumors Reveals Disease-Specific Alterations of Immune Cells. Cell. 2020 Jun;181(7):1643-1660.e17. DOI: 10.1016/j.cell.2020.05.007. PMID: 32470396; PMCID: PMC8558904.

Chen 陈温纯 W, Voos KM, Josephson CD, Li R. Short-Acting Anti-VWF (von Willebrand Factor) Aptamer Improves the Recovery, Survival, and Hemostatic Functions of Refrigerated Platelets. Arteriosclerosis, Thrombosis, and Vascular Biology. 2019 Oct;39(10):2028-2037. DOI: 10.1161/atvbaha.119.312439. PMID: 31315441; PMCID: PMC6761020.

Jin J, Gkitsas N, Fellowes VS, et al. Enhanced clinical-scale manufacturing of TCR transduced T-cells using closed culture system modules. Journal of Translational Medicine. 2018 Jan;16(1):13. DOI: 10.1186/s12967-018-1384-z. PMID: 29368612; PMCID: PMC5784598.

Fekete N, Béland AV, Campbell K, Clark SL, Hoesli CA. Bags versus flasks: a comparison of cell culture systems for the production of dendritic cell-based immunotherapies. Transfusion. 2018 Jul;58(7):1800-1813. DOI: 10.1111/trf.14621. PMID: 29672857.

Special order items will always be manufactured to order – plan for minimum quantities and extended lead times.

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