Corporate Banner
Satellite Banner
Scientific Communities
Become a Member | Sign in
Home>News>This Article

Controlling Nucleation on Production Freeze Dryers

Published: Tuesday, December 18, 2012
Last Updated: Tuesday, December 18, 2012
Bookmark and Share
ControLyo™ technology offers improved vial-to-vial uniformity, reduced cycle times, easier process scale-up and reduced protein aggregation.

SP Scientific has announced that ControLyo™ Nucleation On-Demand Technology can now be retrofitted to a wide range of previously installed production freeze dryers.

The ControLyo™ technology, patented by Praxair Inc., was licensed exclusively by SP Scientific in 2010 for use on development freeze dryers with shelf surface areas < 1.0 sq.-m.

The technology was incorporated into the SP Scientific Lyostar 3 freeze dryer, the first commercial dryer to offer controlled nucleation capability.

Since that time, considerable research has been done at the development scale with controlled nucleation.

ControLyo™ technology offers many benefits to freeze drying in the biotech and pharmaceutical industries including improved vial-to-vial uniformity, reduced cycle times, easier process scale-up, reduced protein aggregation and better conformance to the Food & Drug Administration's Process Analytical technology (PAT), and Quality by Design (QBD) Initiatives.

In order for the benefits demonstrated in development work to offer economic benefits to companies, the technology has to be scalable to production freeze dryers.

SP Scientific and Praxair have demonstrated that many commercial production dryers can be relatively quickly and easily retrofitted to benefit from the advantages offered by ControLyo™ technology.

It has also been demonstrated on production freeze dryers as large as 300 sq.-ft. (27 sq.-m), that controlled nucleation was achieved in nearly 9000 vials, ranging in size from 20ml to 100ml with fill volumes of ¼ and ½.

Economical retrofits and scalability of the technology open opportunities to significantly improve production cycles of lyophilized products, with concomitant reduction in costs.

Further Information
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 2,600+ scientific posters on ePosters
  • More Than 3,800+ 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 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.

Related Content

Freeze Drying Monitoring & Control
SP Scientific enters into an exclusive agreement with PSI to distribute LyoFlux® 200.
Friday, September 12, 2014
Scientific Insights into Lyophilization
Program and venues announced for a one day seminar on freeze drying of pharmaceuticals and biologicals.
Wednesday, August 20, 2014
AAIPharma and SP Scientific Enter into Supply Agreement
Purchase agreement for lyophilizers ControLyo™ nucleation on-demand technology.
Monday, January 13, 2014
Sub-Visible Particles: Impact On Therapeutic Proteins
New LyoLearn webinar to run on 27th June 2013.
Friday, June 07, 2013
SP Scientific and Praxair Expand Technology Agreement
Expansion to commercialize Praxair's ControLyo™ Nucleation on demand technology.
Tuesday, May 29, 2012
Methods for Evaluating Lyophilized Product
SP Scientific, a world leader in freeze drying technology, has announced a new LyoLearn webinar that will discuss standard methods for evaluating lyophilized products.
Tuesday, December 07, 2010
Scientific News
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
New Gene Therapy for Vision Loss From a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Study Removes Cancer Doubt for Multiple Sclerosis Drug
Researchers from Queen Mary University of London are calling on the medical community to reconsider developing a known drug to treat people with relapsing Multiple sclerosis after new evidence shows it does not increase the risk of cancer as previously thought.
Self-Propelled Powder to Stop Bleeding
UBC researchers have created the first self-propelled particles capable of delivering coagulants against the flow of blood to treat severe bleeding, a potentially huge advancement in trauma care.
Five New Genetic Variants Linked to Brain Cancer Identified
The biggest ever study of DNA from people with glioma – the most common form of brain cancer – has discovered five new genetic variants associated with the disease.
Antibody Treatment Efficacious in Psoriasis
An experimental, biologic treatment, brodalumab, achieved 100 percent reduction in psoriasis symptoms in twice as many patients as a second, commonly used treatment, according to the results of a multicenter clinical trial led by Mount Sinai researchers.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Probing the Forces Involved in Creating The Mitotic Spindle
Scientists at The Rockefeller University reveal new insights into the mechanical forces that govern elements of the mitotic spindle formation.
Identifying Cancer’s Food Sensors May Help to Halt Tumour Growth
Oxford University researchers have identified a protein used by tumours to help them detect food supplies. Initial studies show that targeting the protein could restrict cancerous cells’ ability to grow.
Fatty Liver Disease and Scarring Have Strong Genetic Component
Researchers say that hepatic fibrosis, which involves scarring of the liver that can result in dysfunction and, in severe cases, cirrhosis and cancer, may be as much a consequence of genetics as environmental factors.
Scroll Up
Scroll Down
Skyscraper Banner

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
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos