cGMPs / Large Molecule

Successful GMP Production Process for Gene Therapy Platform

Nov 03, 2015

Paris-based Cellectis has announced that a series of three production runs of UCART19, its lead TALEN® gene edited product candidate, was performed, confirming the implementation of Cellectis’ manufacturing process in GMP conditions.

This important milestone shows that UCARTs can be manufactured in GMP conditions. It also demonstrates the industrial production of UCART19, as well as the capacity of Cellectis’ pipeline of UCART product candidates to be manufactured for clinical investigations.

“It is very exciting to lead a novel allogeneic gene therapy platform at the critical time when a R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies,” said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

“Historically, cell-based therapies have grown in the world of individual grafts. With TALEN®-based gene editing they have now started moving toward that of industrial pharmaceutical products broadly available to patients, and Cellectis, as a leading company in the field of gene editing, is at the forefront of this evolution,” added David J.D. Sourdive, Executive Vice President, Corporate Development.

Read the Cellectis press release