Corporate Banner
Satellite Banner
Spectroscopy
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

CEO Frederic Girard Joins Fellow Industry Experts for a QbD Round Table

Published: Friday, August 16, 2013
Last Updated: Thursday, August 15, 2013
Bookmark and Share
New article on quality by design is now available online.

A new article detailing a round table discussion on quality by design (QbD) authored by leading industry experts including Spinnovation Biologics CEO Frederic Girard is now available online.

Entitled ‘QbD and PAT in Upstream and Downstream Processing’, the article details the fundamental principles of QbD, how it is used to improve process control, and the impact technological advances have made on QbD biopharmaceutical upstream process optimization.

Originally published in the July addition of Biopharm International the full article is now available to read at http://bit.ly/SPI52.

The implementation of QbD allows quality assurance to be built into each stage of the development and manufacturing process, ensuring the desired quality of the biological or biopharmaceutical product is guaranteed every time.

In the new article Frederic Girard offers his perspectives on QbD, giving industry insight into modern biopharmaceutical process design.

Mr Girard shows how critical quality attributes can be assessed in modern biopharmaceutical procedures, using the glycosylation of monoclonal antibodies as an illustration.

The article goes on to cover the development of new analytical techniques and methodologies, such as NMR, to reduce performance variability and minimize process failure in large scale biopharmaceutical production.

Spinnovation Biologics offers a variety of unique solutions to those looking to build QbD into biopharmaceutical manufacture. These include Spedia-Predict™, a unique service utilizing a range of Spinnovation’s high-end analytics and chemometric techniques, including Spedia-NMR™, NMR fingerprinting, LC-MS profiling and ICP-OES elemental analysis, to assess critical quality attributes and troubleshoot bio-manufacturing performance issues.

Methods such as Spedia-NMR™ allow operators to analyze fermentation media to monitor the uptake of metabolites and nutrients by the cells, providing full visibility of the presence and concentration of feed components, contaminants and metabolites. Spinnovation’s range of analysis services is also available individually, on a contract or pay-per-sample basis.

“Quality by design is becoming an essential aspect of drug manufacture, particularly within biopharmaceuticals”, commented Mr Girard.

Mr Girard continued, “However the variability and complexities associated with the upstream biological production makes incorporating QbD a complicated process. Spinnovation Technology provides a unique and specialized service, assessing the critical quality attributes of specific biopharmaceutical manufacturing procedures and finding new and better ways for manufacturers to optimize their process.”


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 2,400+ 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

Sinensis Life Sciences Acquires Spinnovation
Addition of Spinnovation expands and strengthens Company’s chemical R&D group.
Saturday, October 04, 2014
Scientific News
A Highly Sensitive Graphene Based Sensor
Researchers at EPFL and ICFO have developed a sensor made from graphene to detect molecules such as proteins and drugs.
Cannabis May Be Used to Treat Fractures
TAU researcher finds non-psychotropic compound in marijuana can help heal bone fissures.
Researchers Reveal Elusive Molecule
A long-standing chemistry puzzle has been solved, with potential implications ranging from industrial processes to atmospheric chemistry.
Optical 'Dog's Nose' Developed to Detect Cancer, Other Diseases
Researchers are using optical spectroscopy to develop a quick, non-invasive “breath test” they believe will have the potential to screen for a variety of diseases, including diabetes, infections and cancers.
Unravelling the Mysteries of Carbonic Acid
Researchers have shown how gaseous carbon dioxide molecules are solvated by water to initiate the proton transfer chemistry that produces carbonic acid and bicarbonate.
NIR Spectroscopy Produces a Handy Image of Blood Circulation
Poor blood circulation can be revealed by a novel form of near infrared (NIR) spectroscopy, say Italian medical researchers.
Combination Imaging Reveals Fuel Cell Damage
A simultaneous view of both chemical distribution and bonding states in fuel cell membranes shows how and where irreversible degradation takes place.
Shining A New Light On The Immune System
Scientists at the University of St Andrews have developed a revolutionary method of identifying cells of the immune system with “molecular fingerprints” which could pave the way for the rapid detection of conditions such as leukaemia and lymphoma from a small blood sample.
Holes in Gold Enhance Molecular Sensing
Electrochemical techniques produce tuneable porous gold films, where the empty spaces enhance light scattering and sensing signals.
Damming hemorrhagic diseases
A potential mechanism to combat diseases caused by haemorrhagic fever viruses has been discovered by researchers.
SELECTBIO

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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!