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

Join For Free

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 3,000+ scientific posters on ePosters
  • More Than 4,400+ 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 Global Scientific Advisory Board
SAB contains world-leading experts in immunology, T-cell biology and chimeric antigen receptors.
Friday, April 01, 2016
TxCell Appoints PCT as its US Manufacturing Partner
TxCell personalized cellular immunotherapies using regulatory T-cells to treat severe chronic inflammatory and autoimmune diseases, announces the appointment of PCT, a Caladrius Company, as its contract manufacturing organization (CMO) in the US.
Wednesday, March 16, 2016
TxCell Reaches Key Milestone
Successful manufacturing validation runs of Ovasave paving the way for a resumption of the CATS29 phase IIb trial in Crohn’s disease in Q2 2016 as planned.
Friday, February 26, 2016
TxCell Signs Strategic Agreement with MaSTherCell
Agreement for European manufacturing of its cell therapy products.
Saturday, December 05, 2015
TxCell Re-acquires Full Rights to its Lead Product Ovasave®
Agreement between TxCell and Trizell to terminate the exclusive option.
Thursday, December 03, 2015
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
Scientific News
Releasing Cancer Cells for Better Analysis
A new device developed at the University of Michigan could provide a non-invasive way to monitor the progress of an advanced cancer treatment.
Releasing Cancer Cells for Better Analysis
A new device developed at the University of Michigan could provide a non-invasive way to monitor the progress of an advanced cancer treatment.
Apricot Kernels Pose Risk of Cyanide Poisoning
Eating more than three small raw apricot kernels, or less than half of one large kernel, in a serving can exceed safe levels. Toddlers consuming even one small apricot kernel risk being over the safe level.
Cell Transplant Treats Parkinson’s in Mice
A University of Wisconsin—Madison neuroscientist has inserted a genetic switch into nerve cells so a patient can alter their activity by taking designer drugs that would not affect any other cell.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
Genetic Markers Influence Addiction
Differences in vulnerability to cocaine addiction and relapse linked to both inherited traits and epigenetics, U-M researchers find.
Lab-on-a-Chip for Detecting Glucose
By integrating microfluidic chips with fiber optic biosensors, researchers in China are creating ultrasensitive lab-on-a-chip devices to detect glucose levels.
A lncRNA Regulates Repair of DNA Breaks in Breast Cancer Cells
Findings give "new insight" into biology of tough-to-treat breast cancer.
COPD Linked to Increased Bacterial Invasion
Persistent inflammation in COPD may result from a defect in the immune system that allows airway bacteria to invade deeper into the lung.
Detection of HPV in First-Void Urine
Similar sensitivity of HPV test on first void urine sample compared to cervical smear.
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
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!