Se hai scelto di non accettare i cookie di profilazione e tracciamento, puoi aderire all’abbonamento "Consentless" a un costo molto accessibile, oppure scegliere un altro abbonamento per accedere ad ANSA.it.

Ti invitiamo a leggere le Condizioni Generali di Servizio, la Cookie Policy e l'Informativa Privacy.

Puoi leggere tutti i titoli di ANSA.it
e 10 contenuti ogni 30 giorni
a €16,99/anno

  • Servizio equivalente a quello accessibile prestando il consenso ai cookie di profilazione pubblicitaria e tracciamento
  • Durata annuale (senza rinnovo automatico)
  • Un pop-up ti avvertirà che hai raggiunto i contenuti consentiti in 30 giorni (potrai continuare a vedere tutti i titoli del sito, ma per aprire altri contenuti dovrai attendere il successivo periodo di 30 giorni)
  • Pubblicità presente ma non profilata o gestibile mediante il pannello delle preferenze
  • Iscrizione alle Newsletter tematiche curate dalle redazioni ANSA.


Per accedere senza limiti a tutti i contenuti di ANSA.it

Scegli il piano di abbonamento più adatto alle tue esigenze.

Economia

COMUNICATO STAMPA - Responsabilità editoriale di Business Wire

STEMCELL Submits Drug Master File for mTeSR™1, the Most Widely Published Cell Culture Medium for Human Pluripotent Stem Cells

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.

STEMCELL Technologies Inc.
Lynn Csontos, Senior Director, Quality Assurance & Regulatory Affairs
public.relations@stemcell.com

Permalink: http://www.businesswire.com/news/home/20181023005060/en

Video Economia


Vai al sito: Who's Who

Modifica consenso Cookie