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

Malvern Publishes New Whitepaper that Explores AQbD

Published: Friday, May 16, 2014
Last Updated: Friday, May 16, 2014
Bookmark and Share
The whitepaper is freely available for download from http://www.malvern.com/beyond_sops.

A new whitepaper on the application of Analytical Quality by Design (AQbD) to particle size assessment has been published by Malvern Instruments. AQbD is an innovative approach to the development and validation of analytical methods that brings the benefits of Quality by Design (QbD) to pharmaceutical analysis.

Malvern’s new whitepaper, ‘Beyond SOPs - Exploring the rigor and requirements of Analytical QbD’, introduces the AQbD concept, explains the associated workflow and illustrates how to apply AQbD when developing methods for laser diffraction particle sizing. The whitepaper is freely available for download from the Malvern resource center http://www.malvern.com/beyond_sops.

QbD strategies are now firmly entrenched throughout pharmaceutical development and manufacture, and the benefits of their broader application are being recognized. AQbD is the application of QbD to analytical method development, which involves systematically identifying the risks associated with the variables that may impact analysis.

It calls for a more detailed understanding of the analytical method and the factors that can influence it, to establish a design space which offers the reward of robust analytical methods that improve throughout the lifecycle of pharmaceutical product.

The whitepaper introduces the regulatory benefits of applying AQbD approach to method development and highlights the parallels between AQbD and the more established QbD workflow. It goes on to present experimental results showing how to scope the method operable design region (MODR).

This is the range of operating parameters that ensures accurate analysis, for both wet and dry laser diffraction particle size analysis. It also covers method validation and the need to implement a carefully constructed control strategy to ensure consistently robust and precise analysis.

Malvern Instruments played a leading role in the introduction of SOP-driven particle size analysis more than a decade ago and delivers the know-how, technology and instrumentation to support continuing innovation in pharmaceutical analysis.

‘Beyond SOPs - Exploring the rigor and requirements of Analytical QbD’ concludes with a review of the tools and software features of the Mastersizer 3000 that can help with the implementation of AQbD to particle size measurement.


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.


Scientific News
Experimental Drug Cancels Effect from Key Intellectual Disability Gene
A University of Wisconsin—Madison researcher who studies the most common genetic intellectual disability has used an experimental drug to reverse — in mice — damage from the mutation that causes the syndrome.
Doubling Down on Dengue
HMS researchers have discovered two ways a compound blocks dengue virus.
Reprogramming Scorpion Venom
‘Twist of nature’ neutralizes toxin.
Tailoring a Suit for Tumor-Penetrating Cancer Meds
For more than a decade, biomedical researchers have been looking for better ways to deliver cancer-killing medication directly to tumors in the body.
Resurrecting an Abandoned Drug
Previously discarded drug shows promise in helping human cells in a lab dish fight off two different viruses.
Safer, Cheaper, Greener and More Efficient System for Organic Synthesis
The new medium not only supports organic synthesis it also produces considerably higher yields of product than pure organic solvents.
Fighting Prostate Cancer
Identifying the most promising compounds which can be used as medications for prostate cancer.
Collaboration to Develop Cancer Therapeutics
Major license agreement with Merck, enabled by Blavatnik Biomedical Accelerator, aims to develop therapy for most common form of acute leukemia.
Faster UVA Molecular Analysis Technology
There are people in the world – chemical engineers, astronomers, national defense scientists investigating an explosion – who need to know just what something is made of, down to the molecular level.
Scientists Synthesize Anti-Cancer Agent
A team led by Rice University synthetic organic chemist K.C. Nicolaou has developed a new process for the synthesis of a series of potent anti-cancer agents originally found in bacteria.
SELECTBIO

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
3,000+ 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!