Using
a SP Scientific LyoStar Freeze Drying System - leading pharmaceutical process
development experts - GILYOS GmbH (Wuerzburg, Germany) will participate in a
research program called "FORMOsA*" which was recently funded with
about two million euros by the German Bavarian Research Foundation. The project
focuses on age-related muscle atrophy (sarcopenia).
In this project, GILYOS will be actively involved in the formulation
development and freeze drying process design and optimization of follistatin
for subcutaneous application. Follistatin is a messenger substance which is
present in almost all types of tissue. The protein effectively inhibits
myostatin which, in turn, plays a key role in skeletal muscle atrophy. Follistatin
might therefore be a promising substance for treating sarcopenia.
To optimize the freeze dried dosage form, GILYOS will use the Lyostar Freeze
Drying system to investigate partially crystalline formulations as such
mixtures allow short process times which are of great economical interest.
The SP Scientific LyoStar3 is a state-of-the-art freeze-dryer that provides
unmatched process accuracy, reliability and unique ease-of-use features. For
applications ranging from process development for scale-up to product
processing for stability studies to formulations work the LyoStar delivers
consistent results other freeze dryers cannot match. The LyoStar features
RTD-controlled shelf temperature accuracy of +/- 0.5°C or better and vacuum
control within 0.1% of set-point. Its robust 5.5 hp cascade refrigeration
system enables shelf pull down from ambient to –40°C in less than 25 minutes,
and the ultra-reliable scroll compressors feature just 3 moving parts.
Available with ControLyo™ Nucleation On-demand Technology, the LyoStar 3
provides R&D and Process Development Scientists with precise control over
their freeze-drying processes.
SP Scientific (www.spscientific.com)
is a leading manufacturer of laboratory-to-production scale freeze dryers /
lyophilizers, centrifugal evaporators and concentrators, thermal management
system and glassware washers. The company sells its products under well-known
brands including Hull, VirTis®, FTS Systems™, Genevac®, and National- Hotpack®.
SP Scientific has ISO 9001:2008 registered production facilities in the USA and
Europe.
GILYOS GmbH (www.gilyos.com) is a
research-oriented contract service company specializing in the field of freeze-drying
(lyophilization) for the pharmaceutical and food industry. The company combines
top-notch, innovative academic research with targeted and straight forward
contract development services. GILYOS has a profound expert knowledge-base in
the field of formulation design for pharmaceuticals and biologicals,
physicochemical examination of materials, freeze-drying cycle development,
process optimization and subsequent scale-up to manufacturing. The company uses
cutting-edge analytical methods to fully characterize drug formulations (liquid
and solid state), with special focus on predictability of product behavior
during the process and long-term storage. One of their key-competences is
implementation of process analytical technology (PAT) in freeze-drying and the
establishment of Quality-by-Design (QbD) concepts.
For further information on the Lyostar Freeze Drying System please contact SP
Scientific on +1-845-255-5000 (+44-1473-240000 in Europe) or email Leslie.Mather@Spscientific.com.
For further information on freeze drying contract research services please
contact GILYOS via email at info@gilyos.com.