Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>Resources>Application Notes>This Application Note
  Application Notes
Scientific News
New Vaccine For Chlamydia to Use Synthetic Biology
Prokarium Ltd, a biotechnology company developing transformational oral vaccines, have announced new funding from SynbiCITE, the UK’s Innovation and Knowledge Centre for Synthetic Biology.
Researchers Discover Immune System’s 'Trojan Horse'
Oxford University researchers have found that human cells use viruses as Trojan horses, transporting a messenger that encourages the immune system to fight the very virus that carries it.
How to Become a Follicular T Helper Cell
Uncovering the signals that govern the fate of T helper cells is a big step toward improved vaccine design.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Sweet Revenge Against Superbugs
A special type of synthetic sugar could be the latest weapon in the fight against superbugs.
Researchers Develop Vaccine that Protects Primates Against Ebola
A collaborative team from The University of Texas Medical Branch at Galveston and the National Institutes of Health have developed an inhalable vaccine that protects primates against Ebola.
Universal Flu Vaccine in the Works
A new study has demonstrated a potential strategy for developing a flu vaccine with potent, broad protection.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Ferring Bets on Bacteriophages to Treat Inflammatory Bowel Disease
Ferring Pharmaceuticals have annoucned that it will collaborate with Intralytix in the latest phase of its early stage development programme for a bacteriophage-based therapy for inflammatory bowel disease (IBD).
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

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