Labelling operator manual describes the procedures steps and the machine use. Cell isolation directly from whole blood without rbc lysis or centrifugation. Biosafe sepax tm automated system has also been on the rise in the past few years, having different yet similarly viable results as the axps system. Nov 19, 2012 biosafe s sepax system receives chinese sfda approval published. The smartmax system is used in tandem with the recently launched sepax 2 system that can efficiently process umbilical cord blood, bone marrow. It combines exclusively with sepax cpro software protocols and kits to process cellular products. Use biosafe disease control to treat algae, slime molds, and scum. For a free estimate, to schedule a consultation or any questions. Dec 17, 2018 this video provides an introduction to the sepax cpro, cell processing system, showing how to start a procedure and preparing and installing the corresponding kit. The fundamental scientific technology relies on a separation chamber that provides both separation. The biosafe acquisition should make the processing much more efficient, vanek added. New england cord blood bank chooses sepax 2 from biosafe. The sefia cell processing system is an automated and functionallyclosed technology developed for cell processing when manufacturing cell therapy products. New england cord blood bank chooses sepax 2 from biosafe as their cord blood processing platform newton ma, 2012 new england cord blood bank, inc.
The sepax 2 s100 is a mobile, closed capability system that efficiently processes umbilical cord blood, bone marrow, peripheral blood or other blood. It provides users with the necessary flexibility through a combination of application specific software protocols and singleuse kits. Sepax cell separation system and singleuse kits, sepax 2. Sepax cord blood processing systems cryoviva india. Eysinsnyon, switzerland and the autoxpress platform. Sepax processes every cord blood unit individually ensuring full traceability and eliminating the risk of accidental mixup with other cord blood units. Routine automated processing of cord blood units using the sepax. The elutra system passes fluid through the cell layer established within a centrifugal field inside the separation chamber. For use on all turf types such as commercial turf, lawns, athletic fields and golf course fairways, greens and tees. Biological separation proteomix hic zenix sec zenixc sec srt sec srtc sec nanofilm sec antibodix proteomix glycomixsax. Sepax cell separation system and single use kits cleared as bk060036 device description. Influence of disulfide bond isoforms on drug conjugation sites in cysteinelinked igg2 antibodydrug conjugates mabs. Sepax cpro cell processing system the sepax cpro cell processing system is an automated and functionallyclosed technology developed for cell processing when manufacturing cell therapy products.
Sepax 2 is the new generation of sepax technology for automated adult stem cell processing. Biosafes sepax system receives chinese sfda approval published. Automate specific steps of your workflow using the sepax cpro cell processing system. Sepax processes every cord blood unit individually ensuring full traceability and eliminating the risk of. A comprising range of biosafes sepax protocol software dedicated for stem cell. Biosafe is not liable for any injury or damage resulting from use of the sepax system. Login to your biosafe support portal customer account. These are usually not disclosed and the user takes on the risk to find out. Qualitative and quantitative cell recovery in umbilical cord blood. It consists of the sefia s platform, dedicated software protocols, and cell processing kits. The system allows for versatile combinations of multiple processing steps, including. Biosafe launches smartmax system for stem cell processing.
The selected stem cells, monocytes, dcs, nk cells, b cells, and t cell subsets allow research in the field of regenerative medicine, adoptive immunotherapy, and graft engineering. Biosafesystems 120 to 420 are optimized for a maximum in capacity at a minimum in dimensions. Nov 16, 2007 most open and manual cell processing procedures have been supplanted by recent technology developments in automated and closed devices. An interesting publication comparing the sepax and axp processing systems was released in july 20, titled qualitative and quantitative cell recovery in umbilical cord blood processed by two. The large, thermodynamically optimized, vacuum insulated lid in attractive design allows access to the materials stored in a second.
Sepax cell separation system and single use kits 510k owner. Biosafe is the world leader in stem cell processing, serving stem cell banks, hospitals and. Sepax cell processing system operator s manual pdf free. Urb mario julia ind park, matadero, san juan, puerto rico 00923 phone. Biosafes sepax system receives chinese sfda approval biospace.
Necbb is pleased to announce that it now processes its cord blood using the sepax 2 system from biosafe. Pdf cord blood processing by using a standard manual. For more information about our services and offers please contact us. Most open and manual cell processing procedures have been supplanted by recent technology developments in automated and closed devices. Use the instrument for multiple applications in cell therapy.
Thanks to the specifically designed application software, the user is able to choose his preferred strategy for an optimal quality of the endproduct. The sepax 2 s100 is a mobile, closed capability system that efficiently processes umbilical cord blood, bone marrow, peripheral blood or other blood derivatives, as permitted by applicable regulatory requirements. Confirm with your local regulatory authority for compliance with other regulations. Sepax provides processing in a closed environment, ensuring safety and sterility. Mar 21, 2017 cell isolation directly from whole blood without rbc lysis or centrifugation. Biosafe website featuring the sefia, sepax 2, and the smartmax. A biosafe device known as the sepax 2, which looks like a large coffee maker, is often used to wash and concentrate the cord blood cells before they are frozen. A biosafe representative should be contacted if any doubt exists concerning the use of the sepax system. See active ingredients, product application, restrictions, and more. It is compliant with iec61010, iec626, and iec62304 standards. Biosafe is not liable for any injury or damage resulting from use of the sepax system that does not conform to the indications in this operators manual biosafe cannot be held responsible for the quality and subsequent effects of products. Learn about the interview process, employee benefits, company culture and more on indeed. Manual hand piece allows precise controllability of the buffy coat level for the clearest visibility. New england cord blood bank chooses sepax 2 from biosafe as.
Furthermore, a help guide is integrated to provide live. The sepax cell separation system is a fullyintegrated, turnkey device for the efficient and reproducible processing of blood and cellular products. The biosafe sepax is a closed systemautomated ficoll density separation device that currently has fda 510k clearance for the processing of umbilical cord blood products. Biosafes sepax system receives chinese sfda approval. Sefia, sepax, smartmax, the biosafe logo, and the biosafe protocol software are either trademarks, registered trademarks, or products of biosafe sa, a division of general electric company, in switzerland andor other countries. The fundamental scientific technology relies on a separation chamber that. The sepax 2 s100 is ce marked and complies with the directive 9342cee for medical devices, including the electrical safety standard iec 606011. Cord blood processing autoxpress axp, sepax, prepacyte. Sepax is a fullyautomated, mobile, closed system for the efficient. Sepax 2 the sepax 2 cell separation system is a fullyautomated, turnkey device for the ef. No other external centrifuge or operator intervention is required. Pro prp provides the highest standard in extracting prp at the most competitive price in the market. Find 6 questions and answers about working at biosafe systems, llc. Sepax cpro cell processing system cytiva, formerly ge.
Furthermore, a help guide is integrated to provide live assistance to the user in case of problem. It is the conclusion of biosafe that the sepax 2 system is substantially equivalent to. Characterization of biosafe sepax manufactured stem cell. A versatile technology platform, the sepax system can be equipped with a large number of protocols or software programs, that allow the processing of various cellular products including bone marrow, cord blood and peripheral blood. The sepax cpro cell processing system is an automated and functionallyclosed technology developed for cell processing when manufacturing cell therapy products. This does derisk and simplify the collection of cord blood, vanek says. This video provides an introduction to the sepax cpro, cell. Color touch screen display, intuitive graphical user. Additional flexibility is provided through a wide range. Mar 14, 2008 considerations from the user s perspective both the axp and the sepax have their pros and cons, and as a potential user, im interested in knowing the breakdown rates and other problems banks have in using the system.
The smartmax system is used in tandem with the recently launched sepax 2 system that can efficiently process umbilical cord blood, bone marrow, peripheral blood or any other bloodlike material. In the manual method, buffy coat and white cell rich plasma layer is. By varying the flow of fluid in the opposite direction to the centrifugal force, the system aligns and collects particles according to size smallest to largest and density lower to higher. Applicable fields of therapy and treatment with prp. The sepax cpro is manufacturing equipment with the ce mark machinery directive 200642ec intended for cell therapy manufacturing in good automated manufacturing practice gamp compliant environments. Although the first described procedure for this purpose was manual and used the. Sepax system the essential choice adult stem cell banking. This video provides an introduction to the sepax cpro, cell processing system, showing how to start a procedure and preparing and installing the corresponding kit. Design control activities have been performed to ensure its safety and performance. Manufacturer information biosafe sa, route du petiteysins, 1262 eysins, switzerland contact us at. With its sepax system biosafe offers a true enabling solution for adult stem cell processing in regenerative medicine applications from benchtop to bedside. Sepax cell separation system and singleuse kits, sepax 2 s.