STEMCELL Submits Drug Master File for mTeSR™1, the Most Widely Published Cell Culture Medium for Human Pluripotent Stem Cells
STEMCELL Technologies announced it has filed a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for the Cellular Therapy Ancillary Material mTeSR™1 and has been issued DMF# 18339.
mTeSR™1 is an Ancillary Material used in basic and translational research to maintain and expand human pluripotent stem cells (hPSCs) in the undifferentiated state. Used in over 1500 peer-reviewed publications, mTeSR™1 is the most widely published feeder-free cell culture medium, with established protocols for applications ranging from cell line derivation to terminal differentiation. With pre-screened raw materials that ensure batch-to-batch consistency, mTeSR™1 provides robust cultures with homogeneous, undifferentiated phenotypes.
“Advancing our cGMP (Current Good Manufacturing Practices) Ancillary Material suite of products is a top priority for STEMCELL. This further demonstrates to our customers that we are a trusted partner for their bench to bedside translational journey,” says Dr. Allen Eaves, CEO and President of STEMCELL Technologies.
“This is the first of many DMFs to come as we bring more cGMP products to market to support the rapidly growing space of cellular therapies.” says Lynn Csontos, Senior Director, Quality Assurance & Regulatory Affairs.
While there is no regulatory requirement for DMFs, the document provides regulators with confidential, detailed information about the product from inception to commercialization. This allows customers to cross reference the DMF in their own approved IND (Investigational New Drug) or BLA (Biological Licensing Application) applications.
To learn more about how mTeSR™1 and other Ancillary Materials offered by STEMCELL Technologies can help advance your translational journey, contact Lynn Csontos, Senior Director, Quality Assurance & Regulatory Affairs.
About STEMCELL Technologies
STEMCELL Technologies supports life sciences research with more than 2,500 specialized tools and services. We offer high quality cell culture media, cell separation technologies, instruments, accessory products and educational resources that are used by scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research globally.
STEMCELL Technologies Inc.
Lynn Csontos, Senior Director, Quality Assurance & Regulatory Affairs
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Global Announces Collaboration with Lipa Meir & Co.28.1.2020 17:30:00 EET | Press release
Andersen Global entered into a collaboration with Lipa Meir & Co., one of the most established and reputable law firms in Israel, adding dimension to the organization’s existing presence in the Middle East. Led by Office Managing Partner Alon Pomeranc, Lipa Meir & Co., founded in 1987, is comprised of more than 80 legal professionals that specialize in a variety of legal services including corporate law, M&A, litigation & dispute resolution, antitrust & competition, banking & finance, energy & infrastructure, capital markets & securities, project finance, cleantech & clean energy, healthcare & life sciences, high-tech & technology, and real estate. The firm has also been consistently recognized by global legal directories, including Chambers and Partners, Legal 500, IFLR1000 and WTR. “Lipa Meir & Co. is committed to and routinely delivers legal services of the highest caliber, and we constantly strive to expand our service offerings,” Alon said. “Our goal is to act as a one-stop shop f
Adecco, World’s Largest HR Staffing Firm, Selects beqom to Advance Pay Processes28.1.2020 17:05:00 EET | Press release
beqom, a cloud-based compensation management software provider, today announced that The Adecco Group, the world's largest human resources provider and temporary staffing firm and a Fortune Global 500 company, has selected beqom’s solution to manage its salary review and bonus compensation processes, integrating directly with Adecco's existing HRIS landscape. “After surveying the market, we found that beqom was clearly the best solution to automate our total remuneration processes,” says Audrey Vissac, Director of Compensation and Benefits at The Adecco Group, France. “We are convinced that beqom will enable us to stay true to our vision that people should be inspired, motivated, and developed to embrace the future of work, starting with our own employees.” beqom initially will be deployed for 9,000 employees in France. With more than 5,200 branches in more than 60 countries and territories around the world, The Adecco Group offers a wide variety of services that include temporary staf
Western Union and France’s La Banque Postale Expand Global Digital Payments28.1.2020 13:59:00 EET | Press release
La Banque Postale, the banking subsidiary of France’s postal services’ operator, La Poste Group and one of France’s major banking networks with 10.3 million active customers today announced - as payment agent of Western Union - the expansion of global digital payment services, powered by Western Union (NYSE: WU), a leader in cross-border, cross-currency money movement and payments. The integration of Western Union’s global cross-border, cross-currency digital money movement platform within La Banque Postale’s mobile app and website will enable more than seven million online registered La Banque Postale customers to access Western Union’s international payment services and experience. La Banque Postale’s customers have the choice to fund their payments within the app or website using bank card and pay-out at Western Union’s Global Retail and Wallet Network. Western Union’s cross-border, cross-currency money movement platform – including global settlement capabilities, network, complianc
B2Broker Secures its Position as a PoP Liquidity Provider with Devexperts dxTrade28.1.2020 13:13:00 EET | Press release
B2Broker, a leading liquidity and technology provider of solutions to the Forex and crypto industry, has signed an agreement with Devexperts, a financial software developer, to license their dxTrade platform. dxTrade is a multi-asset trading solution for brokers which, unlike other existing OTC trading platforms, supports the entire spectrum of assets. This feature will allow B2Broker to become the leading Prime of Prime liquidity provider in the industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200128005354/en/ B2Broker Secures its Position as a PoP Liquidity Provider with Devexperts dxTrade (Photo: Business Wire) B2Broker’s pool of trading platforms currently includes OneZero Hub, PrimeXM xCore, several MT4 and MT5 trading platforms, together with B2Trader (the company’s own Matching Engine platform). With the addition of dxTrade, clients will be able to gain quick and easy access to one of the deepest liquidity poo
ADVA to play key role in OPENQKD project pioneering market-ready quantum-safe communications28.1.2020 11:00:00 EET | Press release
ADVA (FSE: ADV) today announced that its FSP 3000 and FSP 150 platforms will play a pivotal role in the OPENQKD project. Leveraging its ConnectGuard™ technology, ADVA will provide optical and Ethernet encryptors as well as open line systems for multiple testbed locations. Funded by the European Commission, OPENQKD will create and trial a secure communication network across Europe based on quantum key distribution (QKD). The aim of the initiative is to accelerate the commercial adoption of QKD technology and to promote interoperability through an ecosystem of 38 partners, including academic institutions, network operators, and manufacturers of network and QKD equipment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200128005034/en/ ADVA's ConnectGuard™ technology is at the forefront of the OPENQKD project (Photo: Business Wire) “By bringing our technology and expertise to the OPENQKD project, we’re helping to address vital s
Lung Cancer Study Shows Barriers in Patient Access to Care in Europe28.1.2020 10:00:00 EET | Press release
MSD, tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), today presents preliminary results from a study carried out by The Economist Intelligence Unit (The EIU) on lung cancer, which show a fragmented policy approach across Europe. The study underlines that awareness needs to be addressed on multiple fronts to fight the stigma associated with this disease and to ensure patients receive timely access to the best possible care. The data were presented days before the European Commission’s official launch of the stakeholders’ consultation on Europe’s Beating Cancer Plan. “There is no room for complacency in lung cancer; 1 out of 5 of all cancer deaths in Europe is caused by lung cancer and it kills as many Europeans as breast, colon and prostate cancer combined. The study uncovers actionable solutions to empower countries and their health systems to better manage lung cancer, and ultimately, improve the lives of people living with a diagnosis of this treatable disease,” co
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom