Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International



Home > Press > NIST Trumps the Clumps: Making Biologic Drugs Safer

NIST researchers have developed methods and adapted techniques that will allow the pharmaceutical industry to monitor the formation of potentially dangerous aggregates in protein-based drugs.

Image Copyright: IoanaDrutu
NIST researchers have developed methods and adapted techniques that will allow the pharmaceutical industry to monitor the formation of potentially dangerous aggregates in protein-based drugs.

Image Copyright: IoanaDrutu

Abstract:
Scientists at the National Institute of Standards and Technology (NIST) have developed a technique to measure the formation of clumps of proteins in protein-based pharmaceuticals. This first systematic study* clarifies the conditions under which scientists can be assured that their instruments are faithfully measuring the formation of protein aggregates, a major concern because of its impact on quality control and safety in biologic drug manufacturing.

NIST Trumps the Clumps: Making Biologic Drugs Safer

GAITHERSBURG, MD | Posted on July 23rd, 2008

Proteins, a main constituent of many new drugs, are large molecules that have a tendency to stick to each other and form clumps during their manufacture. These clumps have been associated with severe immune responses. In at least one case, the inadvertent creation of protein clumps during the processing of a drug to treat anemia caused an immune reaction in about 250 patients that destroyed their ability to produce red blood cells. Those patients now have to receive blood transfusions every few days to replenish these vital cells.

Events such as this led the Food and Drug Administration to call for the development of sensitive and rapid measurement tools that can detect aggregation of protein drugs during the manufacturing phase. To address the problem, NIST researchers hit upon the idea of adapting a technique known as electrospray differential mobility analysis (ES-DMA). Commonly used to size soot and other aerosols, ES-DMA uses an electric current to vaporize a solution of proteins into tiny charged water droplets, each containing a single protein molecule or protein aggregate. Once these droplets evaporate, the charged proteins and protein aggregates are drawn into an oppositely charged tube. By making controlled adjustments to the voltage of the tube and the velocity of the air flowing through it, researchers can collect particles of a specific size, allowing the proteins and protein aggregates to be precisely sorted and counted.

The NIST team adapted the technique for biopharmaceutical applications. According to researcher Leonard Pease, ES-DMA is tricky to get right, but the NIST team was able to define the conditions needed to electrospray proteins and protein aggregates reliably and repeatedly. NIST scientists favor ES-DMA for its ability to quickly resolve particle sizes differing by as little as 0.2 nanometers, to provide a direct measure of particle size distributions, and to accept bioreactor samples with significantly reduced preparation requirements.

In addition to sizing proteins, Pease said the technique could also be used to accurately size many different types of particles used in medicine, such as the viruses used in the human papillomavirus (HPV) vaccine and gene therapy. "The adaptation of this technology is just one of many excellent examples of how NIST seeks out and works with U.S. industry," says Willie E. May, director of the NIST Chemical Science and Technology Laboratory.

* L. Pease, J. Elliott, D. Tsai, M. Zachariah and M. Tarlov. Determination of protein aggregation with differential mobility analysis: application to IgG antibody. Biotechnology and Bioengineering. Available online at dx.doi.org/10.1002/bit.22017.

####

About NIST
Founded in 1901, NIST is a non-regulatory federal agency within the U.S. Department of Commerce. NIST's mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.

For more information, please click here

Contacts:
Mark Esser

(301) 975-8735

Copyright © NIST

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Researchers develop artificial building blocks of life March 8th, 2024

How surface roughness influences the adhesion of soft materials: Research team discovers universal mechanism that leads to adhesion hysteresis in soft materials March 8th, 2024

Two-dimensional bimetallic selenium-containing metal-organic frameworks and their calcinated derivatives as electrocatalysts for overall water splitting March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

Nanomedicine

High-tech 'paint' could spare patients repeated surgeries March 8th, 2024

Researchers develop artificial building blocks of life March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

The Access to Advanced Health Institute receives up to $12.7 million to develop novel nanoalum adjuvant formulation for better protection against tuberculosis and pandemic influenza March 8th, 2024

Discoveries

What heat can tell us about battery chemistry: using the Peltier effect to study lithium-ion cells March 8th, 2024

Researchers’ approach may protect quantum computers from attacks March 8th, 2024

High-tech 'paint' could spare patients repeated surgeries March 8th, 2024

Nanoscale CL thermometry with lanthanide-doped heavy-metal oxide in TEM March 8th, 2024

Announcements

What heat can tell us about battery chemistry: using the Peltier effect to study lithium-ion cells March 8th, 2024

Curcumin nanoemulsion is tested for treatment of intestinal inflammation: A formulation developed by Brazilian researchers proved effective in tests involving mice March 8th, 2024

The Access to Advanced Health Institute receives up to $12.7 million to develop novel nanoalum adjuvant formulation for better protection against tuberculosis and pandemic influenza March 8th, 2024

Nanoscale CL thermometry with lanthanide-doped heavy-metal oxide in TEM March 8th, 2024

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project