Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
Become a Member | Sign in
Home>News>This Article

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

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 3,500+ scientific posters on ePosters
  • More than 5,200+ 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 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

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
Nanoparticles Offer Promising Platform for Flavivirus Treatment
New nanoparticle effectively vaccinated mice against one dengue strain and could be created to target all four.
Overlooked Molecules Could Revolutionise our Understanding of the Immune System
Researchers have discovered that around one third of all the epitopes displayed for scanning by the immune system are a type known as ‘spliced’ epitopes.
Signaling Pathway Could Be Key to Improved Osteoporosis Treatment
Inhibition of SIK2 enzyme both stimulates bone formation and reduces bone breakdown in animal model.
Less Frequent Cervical Cancer Screening
HPV-vaccinated women may only need one screening every 5 to 10 years with screening starting later in life.
The Power Of Orthogonality In Assessing The Stability Of Biopharmaceuticals
By utilizing orthogonal techniques, researchers can maximize the secure application of all analytical results generated.
Dysfunction in Neuronal Transport Mechanism Linked to Alzheimer’s
Findings confirm mutation-caused problem but also reveal a new therapeutic target.
New Antibody Therapy Permanently Blocks SIV Infection
An international research team has developed an effective treatment strategy against the HIV-like Simian Immunodeficiency Virus (SIV) in rhesus macaques.
3D-Printing in Science: Conference Co-Staged with LABVOLUTION
LABVOLUTION 2017 will have an added highlight of a simultaneous conference, "3D-Printing in Science".
Zika Vaccines Prevent Disorders in Newborn Mice
Disorder immunity transmitted from female mice to pups following vaccination with two Zika vaccines.
Antibody Drug Conjugates May Help Personalize Radiotherapy
Biomarker-driven study shows promise in sensitizing HER2 positive tumors to radiation and chemotherapy.
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos