Biosafe SA

Cordlife launches Asia's largest private cord blood storage facility

admin — Wed, 24 Apr 2013 15:25:16 +0000

Cordlife, a major Biosafe customer in Asia, has inaugurated its new processing facility in Singapore.

Biosafe was pleased to attend the opening ceremony.

Please see the attached Cordlife news release for more information.

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Multi-center Cell Washing poster presented at EBMT 2013

admin — Wed, 17 Apr 2013 14:39:42 +0000

Once again the edition 2013 of the EBMT was a success for Biosafe and we would like to thank you all for your visit.

On 8th April we had the pleasure to welcome Dr. Saccardi for the presentation of a poster presenting the results of a multicentric, prospective trial run in 4 European Transplant Centers, aimed to assess safety and reproducibility of the automated, clinical grade washing system SmartWash^TM.

Here at Biosafe we are convinced that it's important to:

- Reduce cryoprotectant toxicity
- Remove ABO-incompatible RBC stroma and free hemoglobin
- Prevent/Reduce transfusion reactions

Please click here to access the poster

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Biosafe celebrates the one millionth SEPAX kit for cord blood processing

admin — Mon, 11 Mar 2013 08:06:09 +0000

Biosafe is proud to announce that it is celebrating a landmark, with the manufacture of the one millionth proprietary SEPAX separation chamber for cord blood processing kits. This milestone confirms that SEPAX has become the industry standard in cord blood banking, as it has been used in almost half of worldwide processing procedures for cord blood inventory.
Commenting on reaching the one million kit landmark, Founder and Chairman of the Board Claude Fell said: “According to the Worldwide Network for Blood and Marrow Transplantation, over one million stem cell transplants have now been performed and we are proud to be part of the chain enabling cell therapy treatment through innovative cell processing applications. The Biosafe one million separation chamber landmark is likewise a recognition of the commitment of our employees to delivering state of the art quality and reliability in the design and manufacture of our cell separation kits”.
SEPAX also offers a wide range of applications in the rapidly developing regenerative medicine area. It is used in a point of care environment such as cardiovascular and orthopedic, while in biotechnology and pharmaceutical processes it provides a versatile cell processing platform. Applications range from peripheral blood stem cell to bone marrow density gradient separation, as well as cell washing.

About the Biosafe Group
Founded in 1997, the Biosafe Group is active in the design, manufacture and marketing of automated cell processing systems. Headquarted in Switzerland and privately-owned, the Biosafe Group operates through regional subsidiaries (Geneva, Houston, Hong-Kong and Shanghai) and is present in more than 45 countries, either directly or through distributors.

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Biosafe's American subsidiary Receives ISO Certification

admin — Thu, 07 Feb 2013 11:29:10 +0000

Biosafe is pleased to announce the completion of ISO 13485 certification activities by its US subsidiary, Biosafe America, Inc. culminating in the issue of an ISO 13485 certificate by the British Standards Institute (BSI).

Biosafe's headquarters in Switzerland has been ISO certified since 2003 and this additional licence of its North American entity reflects Biosafe's continuous focus on quality.

Olivier Waridel, CEO, commented that “this certification and the quality system that it represents is designed to elevate the quality of our processes in North America and provide further assurance to our customers of our commitment to them.”

Link to the certificate is available here

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Biosafe's Sepax 2 receives SFDA approval

admin — Wed, 14 Nov 2012 08:16:51 +0000

Biosafe is pleased to announce that it has obtained Chinese SFDA registration for its Sepax® device, completing its worldwide registration. Sepax is now available for immediate use in China through Biosafe's recently established subsidiary, Biosafe Medical Device International Trading (Shanghai) Co. Ltd. It is the first fully-automated cell separation system approved for use in the Chinese stem cell processing market. This is a major milestone for the company and we look forward to being a part of the rapid growth occuring in the stem cell processing field in Asia.

Link to the press release is available here

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Multi-center Cell Washing study being presented at the American Society of Hematology (ASH)

admin — Mon, 12 Nov 2012 08:49:13 +0000

A trial designed in 4 European Centers (Basel, Florence, Marseille and Murcia) to assess the reproducibility and feasibility of a fully automated and closed system, the Sepax 2, for washing thawed cellular products provided positive results. The washed product is stable and clinically feasible for several hours after thawing, unlike a frozen unit that still contains cyroprotectant. The study, which will be presented at the ASH conference in Atlanta, GA December 8-11, 2012, aims to promote washing in a closed system. We congratulate each of the centers involved and the large efforts in coordinating for the study. Please visit the Biosafe America team, along with Dr. Riccardo Saccardi who spearheaded the study from Florence, Italy at the ASH conference!

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New England Cord Blood Bank chooses Sepax 2

admin — Mon, 24 Sep 2012 07:24:44 +0000

Biosafe America is excited to be working with New England Cord Blood Bank (NECBB) as they choose to process and bank their cords using the Sepax 2 system. Located just outside of Boston, Massachusetts and established in 1995, NECBB is a privately held family business with three generations of experience in the medical industry. NECBB is dedicated to the preservation of life for families and helps to collect, store and gain access to stem cells should a life-threatening condition arise. They are registered with the FDA and are accredited by the American Association of Blood Banks (AABB). Moving to a fully automated and closed system has allowed their process to be streamlined and effective. We look forward to working with their organization and expertise.

Link to the press release is available at www.prnewswire.com/

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European Approval for a Closed System in Cellular Therapy

admin — Tue, 21 Aug 2012 06:58:30 +0000

Promethera ® Biosciences, a Belgian pharmaceutical company, aims to discover and develop cell therapy products to treat liver diseases using allogenic progenitor cells harvested from healthy human livers. They develop two products based on a newly discovered progenitor cell type, the Heterologous Human Adult Liver Progenitor Cell (HHALPC).

Promethera has developed a process for a closed formulation system for preparing their cells, using a Sepax 2 device, which allows them to have a fully GMP compliant process. The closed formulation system has been approved by the Belgian authorities and was also presented at the 2012 International Society for Cellular Therapy meeting (ISCT) in June of this year. They were able to present additional benefits such as improved reproducibility and less manpower needed using the Sepax 2, which allowed them to safely wash their cryopreserved cells prior to infusion for delivery of a missing or mutated liver enzyme. The process created by Promethera is an important milestone in the field of cellular therapy, and we commend them for gaining approval.

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Cellular therapy in cardiovascular diseases

admin — Thu, 28 Jun 2012 08:46:32 +0000

On July 2 and 3, the Italian College of Cardiac Surgeons is heading an international Expert Forum entitled "“Optimal Treatment of Cardiovascular Diseases: Surgery vs. Innovative Techniques”" in Roma. This event intends at bringing together the cardiovascular community and discussing the best procedures for the treatment of cardiovascular diseases.
Among the international speakers, we are pleased to introduce Dr. Kai Jaquet from Asklepios Clinic in Hamburg, Germany, who will be presenting his work in transendocardial cell therapy in the failing heart using the Sepax® technology. Since 1999, Dr. Jaquet is heading the molecular/cellular laboratory, and Stem Cell Unit of the Department of Cardiology/Cell Biology at the Asklepios Clinic St. Georg, where he is also coordinating various clinical stem cell projects aimed at the development of therapeutic strategies for the treatment of heart failure patients.
More information on this conference is available at www.iccsexpertforum.it/

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U.S. License for University of Colorado Cord Blood Bank received from FDA

admin — Thu, 14 Jun 2012 08:02:19 +0000

The University of Colorado Cord Blood Bank (UCCBB) is operated by ClinImmune Labs and belongs to the cohort of banks funded by HRSA to collect racially diverse donations for the national cord blood inventory.

UCCBB public bank has consented over 28,000 women and banked 8000 cord blood units, of which 620 have been transplanted at 150 different transplant centers in the United States and abroad. Since 2008, UCCBB has used the Sepax® technology to process cord blood and we are happy to see their success in getting licensed by the FDA. UCCBB is now authorized to introduce or deliver for introduction into interstate commerce HPC, Cord Blood manufactured at their site, and are only the second bank in the United States to be approved for licensure. Congratulations to UCCBB!

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