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

Novasep’s €4 M ADC Manufacturing Plant Extension Commissioned

Published: Friday, May 16, 2014
Last Updated: Friday, May 16, 2014
Bookmark and Share
The new Highly Potent API manufacturing capacity at the Le Mans facility will boost Novasep’s ability to meet customer demand for producing anti-cancer therapies.

Novasep has announced that its EUR 4 million (USD 5.5m) investment to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France has reached fruition. The plant extension has been fully qualified and is now being used to scale up validation of a commercial ADC (antibody drug conjugate) payload.

HPAPI, the majority of which are used in anti-cancer therapies, must be produced under very strict regulatory conditions to protect any API substance from cross contamination and protect operators from the highly active properties that are intrinsic to these products.

Contract Manufacturing Organizations (CMOs) increasingly need to upgrade their facilities with higher containment capabilities. Ensuring supply chain continuity is also important to meet the rising demand in the pharmaceutical industry for ADCs.

“We are pleased to see the Le Mans facility commissioned, fully operational and successfully FDA audited,” said Thierry Van Nieuwenhove president of the Synthesis Business unit at Novasep. “There is a high demand from the pharmaceutical industry for CMOs to manufacture potent molecules for use in drugs that improve efficacy and reduce side effects. Novasep has the development and manufacturing capacity, level of specialization and experience to safely address the needs of this market.”

Novasep’s Le Mans plant, notable for producing highly potent cytotoxic pharmaceutical ingredients (APIs) and registered advanced intermediates, recently passed US FDA (Federal Drug Administration) inspection.

The Le Mans production facility combines chemical and purification capabilities to manufacture potent and extremely potent ADC payloads at commercial scale with an OEL (occupational exposure limit) lower than 30 ng/m3 at multi-kg scale per batch.

On top of the classical chemical features in installed confined areas, the production suite can perform cryogenic chemistry at minus 60 degrees Celsius in hastelloy reactors.

The purification suite is equipped with a Prochrom® industrial High-Performance Liquid Chromatography (HPLC) system, which Novasep in Pompey designed and built.


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

Novasep and GTP Technology Announces Partnership
Company has announced partnership with GTP Technology for the development of therapeutic and diagnostic candidates for European biopharmaceutical clients.
Friday, March 25, 2016
Novasep, GTP Technology Join Forces
Partnership offers biotech firms full CDMO services at all development stages from gene to end product.
Tuesday, March 22, 2016
Synthesis and Kilo Lab Extensions to US facility
Company builds a new synthesis laboratory and a kilo lab for US facility.
Tuesday, February 09, 2016
Novasep Adds Synthesis and Kilo Lab Extensions to US Facility
Enhanced capabilities bring Novasep’s unique range of specialized drug development technologies within easier reach of North American customers.
Saturday, February 06, 2016
Novasep, Advanced Biotherapeutics Team Up
Strategic partnership creates a world leading CDMO offer to supply AAV-based viral vectors, an increasingly attractive therapeutic platform for gene therapy.
Wednesday, January 13, 2016
Novasep Strengthens its Advisory Board
Professors Alois Fürstner and Alois Jungbauer, renowned experts in catalysis and purification processes, will help boost innovation at Novasep
Tuesday, September 29, 2015
Novasep Invests €10M to Reinforce its Bioconjugation Services
Expansion marks the company’s readiness for full range Antibody Drug Conjugates CMO services.
Thursday, June 25, 2015
Novasep Further Strengthens Management Team
Pierre-Louis Mikus joins as chief legal officer and Bertrand Waymel is promoted to group human resources director.
Wednesday, May 06, 2015
Novasep and Celladon Execute MYDICAR API Supply Agreement
An innovative, genetically-targeted enzyme replacement therapy based on AAV1/SERCA2a.
Thursday, March 26, 2015
Novasep & Celladon Partner
Novasep has entered into an agreement with Celladon, to commercially biomanufacture Celladon’s Mydicar API.
Tuesday, February 24, 2015
Novasep Enters into an Agreement with Celladon
Company selected to commercially biomanufacture Celladon's Mydicar API.
Thursday, February 19, 2015
Novasep Opens New Office in Thailand
Novasep’s extended presence in South East Asia strengthens the company’s ability to address growing needs in the region’s food and feed markets.
Saturday, December 27, 2014
Novasep to Sell its Bahamian Plant to Local Investor
Company has completed the sale of the Bahamian facility and related business of its fully-owned subsidiary, Pharmachem.
Thursday, October 09, 2014
Novasep Passes FDA Inspections on Two Sites
Novasep wins approval to produce new molecular entity for US market.
Thursday, July 24, 2014
Novasep Reports Full Year 2013 Results
Results show strong growth and beating guidance.
Friday, March 28, 2014
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!