A Glass Act - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

A Glass Act
Duke University researchers have found a possible alternative to lyophilization.


Pharmaceutical Technology
Volume 34, Issue 7, pp. 14


Erik Greb
Most biopharmaceutical companies lyophilize products to dehydrate them and extend their shelf lives. But manufacturers may one day have a new technique that achieves the same goals more quickly.

David Needham, Duke University engineer and chemist, recently developed a process that dries proteins by turning them into glassy microbeads. The transformation occured when Needham's team used a micropipette to release droplets of water-dissolved protein into decanol, an organic solvent.

When water was restored to glassified test proteins, the proteins retained all or most of their original activity. The water that remained in the microbeads was not enough to allow bacteria or fungi to grow. These results suggest that glassification could be a good way to preserve biopharmaceuticals.

The microbeads are not as viscous as lyophilized proteins, so they are unlikely to clog syringes, according to Needham's research. Also, like multiparticulates, the glassified proteins potentially could be covered with polymers for delayed release.

The glassification process takes minutes, while lyophilization sometimes takes days. The new process is cheaper than lyophilization, too, because it requires no specialized equipment.

If Needham's technique can work well in an industrial setting, it could save biopharmaceutical manufacturers money without harming proteins or posing risks to patients. Lyophilization is not the best process for every protein, but, thanks to Needham's team, the industry could soon have another trick up its sleeve.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here