SUBSCRIBE

Breaking News on Biopharmaceutical Development & Manufacturing

Headlines > Upstream Processing

Read more breaking news

 

 

A happy medium for stem cells? Irvine Scientific launches GMP xeno-free offering

Dan Stanton

By Dan Stanton+

17-May-2017

Image: iStock/Sage78
Image: iStock/Sage78

Xeno-free and cGMP-manufactured media are highly desired by cell therapy developers, says Irvine Scientific as it launches a medium for hematopoietic stem and progenitor cells (HSPCs).

According to Irvine Scientific, its latest serum-free, xeno-free PRIME-XV basal medium supports the robust expansion of hematopoietic progenitors while maintaining their multipotency, and is now available for customers working with HSPCs.

HSPCs come from blood or bone marrow of donors and are rare (just 1 in 100,000 in peripheral blood cells and 1 in 10,000 in bone marrow), so growing sufficient numbers for therapeutic purposes while maintaining progenitor cell properties is a challenge.

“This new product optimises the cell yield by enhancing cell proliferation without losing the identity of hematopoietic progenitors, so one would get the most numbers of desired cell types suitable for transplantation,” Irvine product line manager Duncan Liew told Biopharma-Reporter.

This is the latest in Irvine’s xeno-free range of medium, after the Californian-based firm launched a similar offering for neural cells last July and an animal-free cell growth medium for T cell cultures in January .

“The use of xeno-free media is critical to eliminate the risk of contamination from animal products, such as FBS [fetal bovine serum], and to provide lot-to-lot consistency, ensuring optimal cell yield and good quality cell cultures,” Lieuw said.

“Many cell-based therapies have already moved towards the use of serum-free and xeno-free media.”

He added there is no one size fits all solution for cell-based therapies. “All are depending on the applications and cell types. For example, some cells are grown on monolayer, some could be grown in suspension and such large scale expansion could require the use of bioreactors.”

But the PRIME-XV offering does offer the advantage that it is produced under current good manufacturing practice (cGMP). This is “now highly desired starting from preclinical and early stages of clinical trials,” among customers, Lieuw said.

“This new medium is cGMP-manufactured and will come with a Drug Master File registration with FDA – another benefit we offer compared to many other competitors media!”

Related products

Key Industry Events

 

Access all events listing

Our events, Shows & Conferences...