STEMCELL dient Drug Master File in voor mTeSR™1, het meest verspreide celkweekmedium voor menselijke pluripotente stamcellen
VANCOUVER, British Columbia—(BUSINESS WIRE)–
STEMCELL Technologies heeft aangekondigd dat het een Type II Drug Master File (DMF) heeft ingediend bij de Food and Drug Administration (FDA) voor het Cellular Therapy Ancillary Material mTeSR™1 en is uitgegeven DMF# 18339.
mTeSR™1 is een aanvullend materiaal dat gebruikt wordt in basis- en translationeel onderzoek om menselijke pluripotente stamcellen (hPSC’s) in ongedifferentieerde staat te houden en uit te breiden. Gebruikt in meer dan 1500 peer-reviewed publicaties, is mTeSR™1 het meest gepubliceerde feeder-vrije celkweekmedium, met gevestigde protocollen voor toepassingen variërend van cellijnafleiding tot terminale differentiatie. Met vooraf gescreende grondstoffen die batch-naar-batch consistentie garanderen, biedt mTeSR™1 robuuste culturen met homogene, ongedifferentieerde fenotypes.
STEMCELL Submits Drug Master File for mTeSR™1, the Most Widely Published Cell Culture Medium for Human Pluripotent Stem Cells
VANCOUVER, British Columbia–(BUSINESS WIRE)– 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.
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Contacts
STEMCELL Technologies Inc.
Lynn Csontos, Senior Director, Quality Assurance & Regulatory Affairs
public.relations@stemcell.com