Corporate Banner
Satellite Banner
Chromatography
Scientific Community
 
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 3,300+ scientific posters on ePosters
  • More than 4,800+ 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

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 and Celladon Execute MYDICAR API Supply Agreement
An innovative, genetically-targeted enzyme replacement therapy based on AAV1/SERCA2a.
Thursday, March 26, 2015
Novasep Reports Full Year 2013 Results
Results show strong growth and beating guidance.
Friday, March 28, 2014
Novasep Appoints CEO Michel Spagnol as Chairman
Novasep presents strategic developments.
Wednesday, March 05, 2014
Novasep Expands and Opens Subsidiary in India
Subsidiary to meet India’s increasing need for high efficacy processes for its fast growing food and feed industries.
Friday, February 14, 2014
Novasep Expands and Opens Subsidiary in India
Novasep Process Engineering Services PVT LTD will meet India’s increasing need for high efficacy processes for its fast growing food and feed industries.
Monday, December 16, 2013
Novasep Appoints Christian Thiry as Chief Financial Officer
CFO appointment is a key milestone in Novasep’s senior management recruitment program.
Thursday, August 29, 2013
Novasep Appoints Fine Chemicals Market Director
Company strengthens its position by appointing Udo Steinhauer.
Thursday, June 06, 2013
Novasep Invests to Build World's Largest Chromatography Plant for the Pharmaceutical Industry
The investment of €30 million allows Novasep to build the largest chromatography plant for the production of a large volume commercial API’s in Mourenx, France.
Wednesday, October 10, 2012
Novasep Announces Three Million Euro Investment
Company to boost its highly potent API manufacturing capabilities in Le Mans, France.
Friday, July 20, 2012
Novasep Opens New Shanghai Facilities
New site increases Novasep’s process development and engineering capabilities to supply turnkey purification processes in East Asia.
Thursday, March 29, 2012
Novasep and instrAction Expand Alliance to Include Taxane Purification
Companies will develop solutions to change manufacturing paradigm for new and generic anti-cancer compounds.
Wednesday, February 09, 2011
Scientific News
Core-Shell Columns in HPLC: Food Analysis Applications
Explore the most recent applications of core-shell columns in food analysis.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Determination of 13 Organic Toxicants in Human Blood
Researchers have utilised liquid-liquid extraction coupling HPLC-MS/MS to identify and quantify organic toxicants in human blood.
Massive Helium Discovery a "Game Changer" for Medical Industry
A new development is gas exploration has yielded the discovery of a huge helium gas field, which could help relieve the dwindling supply.
Making Metabolite Identification More Efficient
Metasense combines the industry's most-comprehensive metabolic transformation prediction with efficient analysis of LC/MS analytical measurements to identify, visualize, and report chemical biotransformations.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Origins of Life Delivered from Space
Researchers have for the first time shown that ribose, a sugar that is one of the building blocks of genetic material in living organisms, may have formed in cometary ices.
Protecting Yourself from Mosquitoes Just Got Easier
New GoClip™ from RESCUE!® offers six days of protection from mosquitoes as well as biting flies and ticks.
Structure of Essential Digestive Enzyme Uncovered
Using a powerful combination of techniques from biophysics to mathematics, researchers have revealed new insights into the mechanism of a liver enzyme that is critical for human health.
Skyscraper Banner

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,800+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!