Stem Cell

Pic:getty/MG

EMA pilot to provide regulatory support to selected ATMP developers

By Rachel Arthur

The European Medicines Agency (EMA) will provide up to five selected advanced therapy medicinal products (ATMPs) with enhanced regulatory support - and in the process hopes to learn how to improve the regulatory processes for other ATMP drugs in the future.

© GettyImages/Bet_Noire

Japan backs Takeda stem cell therapy targeting Crohn’s disease

By Jane Byrne

Takeda has received approval from Japan’s ministry of health to manufacture and market its stem cell therapy, Alofisel, for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease (CD).

© GettyImages/Andrew Brookes

Generate looks to in-house stem cell manufacturing

By Jane Byrne

Generate Life Sciences is establishing a GMP facility in La Jolla, California that it says will enable end-to-end manufacturing of newborn stem cell biologics, bolstering supply and safeguarding clinical research.

Image: iStock/cacaroot

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

By Dan Stanton

Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

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