Market leaders in temperature controlled
microscopy, Linkam Scientific Instruments report on the use of their THMS600
temperature stage as part of a system from Biopharma Technology Limited (BTL)
to characterize freeze drying processes at the University of Iowa.
The University of Iowa Pharmaceuticals (UIP) is the largest and most
experienced university-affiliated FDA-registered pharmaceutical manufacturing
facility in the United States. UIP has been developing formulations,
manufacturing products, and conducting analytical testing in compliance with
current Good Manufacturing Practices (cGMPs) for over 30 years. The facility is
the only one of its kind offering the range and scope of services needed by
commercial clients. Additionally, UIP has performed work for numerous
government agencies, including the National Cancer Institute, the Centers for
Disease Control, the World Health Organization, the National Institutes of
Health, and the Food and Drug Administration.
One area of interest is the understanding of lyophilisation processes. Key to
this is the characterization instrumentation from Biopharma Technology Limited.
Two systems are in use: The Lyotherm 2 provides integrated Differential Thermal
Analyser (DTA) and electrical impedance (Zsinφ) capability in a single
instrument. The Lyotherm 2 is designed to measure glass transition (Tg'),
eutectic (Teu) and melting (Tm) temperatures relevant to freeze-drying
formulations. The Lyostat 2 is a fully integrated freeze-drying microscope
which incorporates a Linkam THMS 600 cryo temperature stage. This enables
critical events such as collapse and melting to be observed in situ, as well as
characteristics such as skin or crust formation to be observed and identified.
The coupled Lyostat 2 and Lyotherm 2 units provide valuable information for
both formulation and cycle development processes. With UIP's in-house expertise
in lyophilization, this combination will allow quicker and more efficient
development of lyophilization cycles.
The team is led by Professor Lee Kirsch of the College of Pharmacy. His
research interests include macromolecular peptide pro-drugs for targeted drug
delivery, the kinetics and mechanisms of the chemical instability of drugs, the
kinetics and mechanisms of the physical instability of dispersed and colloidal
systems, and pharmaceutical package integrity technologies. One of his team
describes the main work with the Lyostat 2 system. "We use the system to
find out the collapse temperature for various clients freeze drying
formulations." Until the arrival of the Lyostat 2, determining the
collapse temperature would take hours in the lab in an attempt to understand
the critical temperatures needed to produce the best product. The ability to
provide accurate thermal characterisation right down to -196°C significantly
reduced the time and complexity in the process enabling scientists to determine
these key temperatures and so create the best product quickly and simply.
The collaboration between BTL and Linkam has enabled a practical solution to
questions on freeze drying previously only answered with difficulty. Adding the
temperature stage has brought benefits to BTL through being able to provide
quality pictures to illustrate the process at varying precisely controlled
temperatures and pressures while, for Linkam, it has introduced the company to
an exciting and growing market.
Visit Linkam at
http://www.linkam.co.uk/
and learn about the broad range of applications in the field of temperature
controlled microscopy.
Subscribe to any of our newsletters for the latest on new laboratory products, industry news, case studies and much more!
Request your free copies HERE
Popular this Month
Top 10 most popular articles this month
Today's Picks
Looking for a Supplier?
Search by company or by product
Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.
Lab Bulletin is published by newleaf marketing communications ltd.