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

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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 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 to Present its Cellular Immunotherapy Developments
Dr. Miguel Forte and Dr. Arnaud Foussat will present at three forthcoming leading cell and gene therapy and ophthalmology conferences.
Friday, September 18, 2015
TxCell Granted US Orphan Drug Designation for Col-Treg
A first-in-man clinical study is planned to start in 2016, with top line results expected end 2017.
Tuesday, September 15, 2015
TxCell Announces Publication of Preclinical Efficacy Results for Col-Treg
Results published in Investigative Ophthalmology and Visual Science (IOVS) provide details on the demonstration of Col-Treg’s therapeutic potential in autoimmune uveitis and will support its ongoing clinical development.
Thursday, September 10, 2015
TxCell Receives Fast Track Designation from FDA for Ovasave®
TxCell’s lead product designated for the treatment of moderate to severe Crohn’s disease.
Wednesday, August 05, 2015
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
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Revolutionary Technologies Developed to Improve Outcomes for Lung Cancer Patients
Breath test to detect lung cancer brings oxygen directly to the wound.
NIH Supports New Studies to Find Alzheimer’s Biomarkers in Down Syndrome
Initiative will track dementia onset, progress in Down syndrome volunteers.
Dementia Linked to Deficient DNA Repair
Mutant forms of breast cancer factor 1 (BRCA1) are associated with breast and ovarian cancers but according to new findings, in the brain the normal BRCA1 gene product may also be linked to Alzheimer’s disease.
Using Drug-Susceptible Parasites to Fight Drug Resistance
Researchers at the University of Georgia have developed a model for evaluating a potential new strategy in the fight against drug-resistant diseases.
Boosting Breast Cancer Treatment
To more efficiently treat breast cancer, scientists have been researching molecules that selectively bind to cancer cells and deliver a substance that can kill the tumor cells, for several years.
New Gene Map Reveals Cancer’s Achilles’ Heel
Team of researchers switches off almost 18,000 genes
New Discovery Sheds Light on Disease Risk
Gaps between genes interact to influence the risk of acquiring disease.
How Cells ‘Climb’ to Build Fruit Fly Tracheas
Mipp1 protein helps cells sprout “fingers” for gripping.
Research Finding Could Lead to Targeted Therapies for IBD
Findings published online in Cell Reports.
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos