Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
Become a Member | Sign in
Home>Resources>Application Notes>This Application Note
  Application Notes
Scientific News
Speeding Up the Process of Making Vaccines
System uses a freeze-dry concept to develop "just-add-water" solution.
Surprising Trait Found in Anti-HIV Antibodies
Scientists at The Scripps Research Institute (TSRI) have new weapons in the fight against HIV.
New Method Identifies Up to Twice as Many Proteins and Peptides
An international team of researchers developed a method that identifies up to twice as many proteins and peptides in mass spectrometry data than conventional approaches.
The Do’s and Don’ts of SPR Experiments
Surface Plasmon Resonance (SPR) is a technique that is becoming more widely used, particularly by anyone who wants to obtain accurate on (association) and off (dissociation) rates for biomolecular binding.
Genetically Engineering Algae to Kill Cancer Cells
New interdisciplinary research has revealed the frontline role tiny algae could play in the battle against cancer, through the innovative use of nanotechnology.
Novel Stem Cell Line Avoids Risk of Introducing Transplanted Tumors
Progenitor cells might eventually be used to repair or rebuild damaged or destroyed organs.
Single Vaccine for Chikungunya, Related Viruses May be Possible
What if a single vaccine could protect people from infection by many different viruses? That concept is a step closer to reality.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
Molecule Proves Key to Brain Repair After Stroke
Scientists found that a molecule known as growth and differentiation factor 10 (GDF10) plays a key role in repair mechanisms following stroke.
Circadian Clock Controls Insulin and Blood Sugar in Pancreas
Map of thousands of genes suggests new therapeutic targets for diabetes.
Scroll Up
Scroll Down

Differentiation and characterization of subvisible particulates in therapeutic protein products
Bookmark and Share

Malvern Instruments Limited

There is an expectation from regulatory agencies for companies to monitor and, if required, reduce the levels of sub-visible particles present in therapeutic protein from manufacture through their complete shelf life. While immunogenicity can be induced by a variety of mechanisms, contamination by non-protein material is known to be a potential cause. The presence of silicone oil in parenterals has attracted considerable interest, due to its use in syringe-based administration systems and the difficulty in distinguishing oil droplets from protein aggregates. In addition to protein aggregates, non-biological contaminants may act as nucleation points for aggregate growth. Consequently, particle sizing alone is not sufficient. 

Guidance from the FDA for the biopharmaceutical industry states “Naturally sourced products should be evaluated for other components, protein and non-protein”. Resonant Mass Measurement (RMM) technology in the Archimedes system measures the buoyant mass of particles passing through a cantilever, allowing detection of particles with a density different to that of the buffer solution. Consequently, the Archimedes provides the ability to distinguish between negatively buoyant particles, such as proteins, and positively buoyant particles, such as silicone oil. 

This application note provides an example of how Archimedes can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress. 

Further Information

Related Content

Oxford Researcher Explains Central Role of Microcalorimetry in Meningitis Vaccine Development
A highly sensitive, fully automated, high-throughput differential scanning calorimeter.
Saturday, October 24, 2015
Malvern Instruments Establishes New Biopharmaceutical Applications Laboratory
Malvern Instruments has established a new biopharmaceutical applications laboratory in the heart of San Diego’s biotechnology cluster.
Friday, July 31, 2015
Researchers use Nanoparticle Tracking Analysis to Study Extracellular Vesicles
Scientists are working to find a way deliver a specific microRNA species capable of retarding the growth of tumor cells.
Thursday, May 28, 2015
Malvern Completes Acquisition of MicroCal
Company announces purchase of Archimedes product from Affinity Biosensors.
Friday, July 25, 2014
Malvern to Acquire MicroCal Business from GE
Malvern Instruments has entered into an agreement with GE Healthcare Life Sciences to acquire the company’s MicroCal™ microcalorimetry business.
Wednesday, June 04, 2014
Regional Growth Fund Success Sees Malvern Instruments Stepping up UK Recruitment
£3 million support from the UK Government’s Regional Growth Fund (RGF) will lead to the creation of 47 new jobs in the UK over the next five years.
Tuesday, May 20, 2014

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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos