Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

TxCell Obtains Manufacturing Accreditation Status

Published: Wednesday, December 04, 2013
Last Updated: Wednesday, December 04, 2013
Bookmark and Share
Company receives accreditation from ANSM for its French cell therapy manufacturing facility.

TxCell SA has announced that it has received a Manufacturing Accreditation delivered by the French National Agency for Drug Safety (ANSM). The status has been received for its cell therapy production site in Besançon, France.

The TxCell manufacturing facility, located at the French National Blood Center of Bourgogne Franche-Comté region, is now authorized to produce biological investigational medicinal products in accordance with the European Union Directives 2001/83/EC and 2001/20/EC, as required for the manufacturing of Advance Therapy Medicinal Product (ATMP).

TxCell’s lead autologous Ag-Treg cell-based immunotherapy, Ovasave®, is currently in phase II development for the treatment of Crohn’s disease in patients who are refractory to current treatments. Ovasave has been classified as ATMP since 2009 by the European Medicines Agency (EMA).

The newly accredited TxCell manufacturing facility will enable production of pharmaceutical grade batches of Ovasave for the next phase IIb study, planned to start mid-2014.

“This manufacturing accreditation from ANSM is a key milestone in the planned future development and growth of TxCell,” said Damian Marron, Chief Executive Officer. “This is essential for scaling up manufacturing of TxCell’s lead product Ovasave for our forthcoming Phase IIb in refractory Crohn’s Disease. This in turn allows us to accelerate the development of all our innovative, personalized cell-based immunotherapies. These therapies target niche and orphan indications for which there are few or no treatment options and a high unmet medical need. There are currently 160,000 such patients per year in Europe and in the US for Crohn’s Disease alone.”

“This Manufacturing Accreditation recognizes the quality of our facility designed to produce highly innovative, personalized cell based immunotherapy products.” said Eric Pottier, Executive Director Supply Chain & Qualified Person. “This is a reward for the ongoing investment by TxCell and the TxCell team. We also wish to thank the French National Blood Center for contributing their strong expertise in the cell therapy production field, in particular Dr. Pierre Tiberghien, Scientific Director, and Dr. Pascal Morel, Director.”

The TxCell manufacturing facility contains 440m² of premises. These premises includes 120m² of cleanroom suits of which 80m² are Grade B suits under GMP EU classification, TxCell has a manufacturing capacity of more than 20 cell therapy batches in parallel.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

TxCell Appoints MaSTherCell for the Manufacturing of Ovasave®
First clinical batches could be manufactured as soon as Q2 2016.
Saturday, August 01, 2015
TxCell Announces FDA Acceptance of IND for Ovasave
IND grants TxCell option of extending current phase 2b study from EU to US.
Tuesday, June 30, 2015
TxCell Announces a Temporary Partial Hold of Activities at its Pilot Manufacturing Unit
Company expects only potential limited impact on clinical product timeline.
Wednesday, June 24, 2015
TxCell: Financial Information for the First Quarter of 2015
Company reports its revenues for 1Q 2015.
Thursday, May 14, 2015
TxCell Appoints Stéphane Boissel as Chief Executive Officer
Company promotes Miguel Forte to Chief Operating Officer.
Saturday, May 02, 2015
TxCell and Trizell Amend Collaboration Agreement
Company appoints the Cell Therapy Catapult to perform process and manufacturing development.
Friday, May 01, 2015
Strengthening of Cash Position and Development of ASTrIA Product Platform
Positive results for Col-Treg, second product candidate, in an auto-immune uveitis model.
Tuesday, April 07, 2015
TxCell to Present at Upcoming US and French Investment Conferences
Conferences include Alliance for Regenerative Medicine's 3rd Annual Regen Med Investor Day, New York, March 25 and the Portzamparc PEA-PME Forum, Paris, April 1.
Saturday, March 28, 2015
Key TxCell Patent to be Granted in the US for its Lead Product Ovasave®
Patent ensures protection for Ovasave® in the US until 2030 minimum.
Thursday, March 19, 2015
TxCell to Present at ROTH Capital Partners Investor Conference in US
TxCell invited to speak at largest US meeting for investors in emerging growth companies.
Friday, February 27, 2015
TxCell Reports Revenues for 2014 and Updates on Upcoming Milestones
Ovasave and Col-Treg regulatory status update in the United States, expected mid-2015.
Thursday, February 05, 2015
TxCell Receives EUR 1 Million Milestone Payment
Milestone payment triggered by first patient enrolment in the phase IIb clinical trial for refractory Crohn’s disease.
Thursday, January 29, 2015
TxCell to Present at the Cell & Gene Therapy Forum 2015
Company to present its experience with Cell Therapy at the Cell & Gene Therapy Forum 2015, Washington.
Saturday, January 24, 2015
TxCell Receives EU Orphan Drug Designation for Col-Treg
A proof of principle clinical study is planned to start in the first half of 2015, with top line results of this study expected mid-2016.
Friday, December 19, 2014
TxCell Announces Start of Phase IIb Clinical Trial with Ovasave®
Top line results of this study are expected end 2016/early 2017.
Tuesday, December 09, 2014
Scientific News
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Self-Assembling, Biomimetic Membranes May Aid Water Filtration
A synthetic membrane that self assembles and is easily produced may lead to better gas separation, water purification, drug delivery and DNA recognition, according to an international team of researchers.
Researchers Discover Immune System’s 'Trojan Horse'
Oxford University researchers have found that human cells use viruses as Trojan horses, transporting a messenger that encourages the immune system to fight the very virus that carries it.
Crystal Clear Images Uncover Secrets of Hormone Receptors
NIH researchers gain better understanding of how neuropeptide hormones trigger chemical reactions in cells.
How Cholesterol Leads to Clogged Arteries
A new study shows that when immune cells called neutrophils are exposed to cholesterol crystals, they release large extracellular web-like structures that trigger the production of inflammatory molecules linked to artherosclerosis.
Genetic Tug of War
Researchers have reported on a version of genetic parental control in mice that is more targeted, and subtle than canonical imprinting.
Ultrafast DNA Diagnostics
New technology developed by UC Berkeley bioengineers promises to make a workhorse lab tool cheaper, more portable and many times faster by accelerating the heating and cooling of genetic samples with the switch of a light.
Researchers Discover New Type of Mycovirus
Virus infects the fungus Aspergillus fumigatus, which can cause the human disease aspergillosis.
Error Correction Mechanism in Cell Division
Cell biologists have reported an advance in understanding the workings of an error correction mechanism that helps cells detect and correct mistakes in cell division early enough to prevent chromosome mis-segregation and aneuploidy, that is, having too many or too few chromosomes.
How to Become a Follicular T Helper Cell
Uncovering the signals that govern the fate of T helper cells is a big step toward improved vaccine design.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!