Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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

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 3,200+ scientific posters on ePosters
  • More Than 4,600+ 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
Spinnovation Transfers its Entire Operation to Pivot Park
The new location has enabled Spinnovation to double the size of its facilities, to support the growth of its business.
Monday, January 13, 2014
Spinnovation Expands in to the US
Spinnovation collaborate with Quantum Tessera in Pennsylvania.
Tuesday, April 17, 2012
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
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.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Manufactured Stem Cells to Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Dengue Virus Exposure May Amplify Zika Infection
Researchers at Imperial College London have found that the previous exposure to the dengue virus may increase the potency of Zika infection.
Gender Determination in Forensic Investigations
This study investigated the effectiveness of lip print analysis as a tool in gender determination.
Identifying Novel Types of Forensic Markers in Degraded DNA
Scientists have tried to verify the nucleosome protection hypothesis by discovering STRs within nucleosome core regions, using whole genome sequencing.
Proteins in Blood of Heart Disease Patients May Predict Adverse Events
Nine-protein test shown superior to conventional assessments of risk.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Starving Stem Cells May Enable Scientists To Build Better Blood Vessels
Researchers from the University of Illinois at Chicago College of Medicine have uncovered how changes in metabolism of human embryonic stem cells help coax them to mature into specific cell types — and may improve their function in engineered organs or tissues.
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!