The essential choice in cell processing
Established in 1997 The Biosafe Group is an internationally active medical technology company with its roots in the Lake Geneva region of Switzerland. Since it was established in 1997, the company has grown to become the industry standard in cord blood banking and in the fast developing field of cellular therapy, serving its customers with innovative cell processing solutions. Biosafe SA is a US FDA-registered establishment as well as an ISO 9001:2008 and ISO 13485:2003/AC:2007 certified company, working under the European Medical Devices Directive 93/42/EEC annex II.3. The Sepax has been cleared by the FDA and was approved in China by the SFDA.
Industry standard in automated cell processing To date, over 1000 Sepax systems have been installed in stem cell laboratories and hospitals in more than 50 countries worldwide. For adult stem cell banking Sepax was the first automated cell processing technology to be specifically developed for use in cord blood banks. With its complete range of accessories it allows the safe and individual preparation of a child s stem cells for long-term storage. It is today the industry standard in public and private cord blood banks and is used by a majority of the world s leading public banks that form the NetCord organization. For regenerative medicine A safe and reliable system, Sepax has long found it s place in the transplantation of hematopoietic stem cells and point-of-care cell therapy indications. More recently, the development and manufacture of innovative cell-based and gene therapy products require cutting-edge technologies like Sepax. Sepax has been adopted in leading clinical studies and products in a multitude of emerging biological therapies.
Our milestones 2014 Full Chinese product registration 2013 Opening of Latin America subsidiary 2013 Introduction of Smart-Max for automated cryopreservation & thawing 2013 One millionth separation chamber (single use kit) produced 2012 Chinese SFDA clearance for Sepax 2 2011 800,000 procedures, 800 Sepax devices in 50 countries 2011 Worldwide market launch of Sepax 2 2008 70% growth per year and profitability 2008 Industry standard : every 3 minutes a cord processed by Sepax 2008/09 Opening of US and Asian subsidiary 2007 US FDA 510(k) + Japan MLHW 2005 Extension of developments to regenerative medicine 2000 Introduction of Sepax for cord blood processing
Worldwide presence Our innovative product solutions are marketed worldwide through our direct sales force and a growing network of distribution partners. Biosafe products are used around the world in hundreds of cell processing procedures every day with a broad scope of use.
Sepax platform technology The development and manufacture of innovative cell-based and gene therapy products requires cutting-edge technologies, which meet experts needs. With a proven track record, the Sepax solution for automated cell processing meets these core requirements in addition to ensuring a pharmaceutical-grade cellular product. Sepax 2 fully automated and integrated system Automated & standardized solutions for cell processing Closed and mobile system with full traceability Highly efficient and consistent cell recoveries Single use kit closed sterile processing environement Custom-made applications and process control Protocol cell separation software
Partnering with Biosafe means working with a team of experts with 17+ years experience in cell processing. Cell concentration, separation and washing Sepax 2 Cell based product Cell expansion Point-of-care Laboratory GMP Stem cells Cryo-preservation Injection into the patient
Swiss made quality & service We incorporate in-house : Research & development Production facilities Quality assurance to guarantee our clients the best quality & service FDA 510(k) cleared
Our mission Since the beginning of Biosafe s activities, every sample processed with our system is important to us as it represents a hope for life. It reflects our philosophy of respecting the unique, irreplaceable nature of each human being. Evidence of the outstanding capabilities of adult stem cells is increasing every day and we at Biosafe will always be looking for innovation in cell processing. Develop and implement enabling technologies to enhance cord blood banking and regenerative medicine
Contact details Headquarters Biosafe SA Asia Office Biosafe Asia Pacific Ltd. America Office Biosafe America, Inc. Rte du Petit-Eysins 1 1262 Eysins Switzerland t +41 22 365 27 27 f +41 22 365 27 37 info@biosafe.ch Room 3012, 30/F Tower 1 The Gateway, 25 Canton Road Tsim Sha Tsui, Kowloon Hong Kong t +852 2956 7500 f +852 2956 2110 info@biosafeasiapacific.com 1225 North Loop West Suite 120, TX-77008 Houston USA t +1 713 936 2615 f +1 713 456 2766 info@biosafeamerica.com China Office Biosafe Medical Device International Trading (Shanghai) Co. Ltd. Rm 80, 38F, Park Place No. 1601 Nanjing West Road Shangai 20040 China t +86 21 61373214 f +86 21 61373210 info@biosafeasiapacific.com 中 国 分 公 司 唯 安 医 疗 设 备 贸 易 ( 上 海 ) 有 限 公 司 中 国 上 海 市 静 安 区 南 京 西 路 1601 号 越 洋 广 场 38 楼 80 室 上 海 20040 t +86 21 61373214 f +86 21 61373210 info@biosafeasiapacific.com Latin America Office Biosafe Latin America Chedid Jafet, 222 5th Floor Block D Vila Olímpia 04551-065 São Paulo Brazil t +55 11 2655 1731 info@biosafelatinamerica.com www.biosafe.ch
www.biosafe.ch