Scientists
from Malvern Instruments and from biological ingredients and technology
developers, Novozymes Biopharma, have successfully completed the first
phase of extensive collaborative studies. These have involved the
application of Malvern's light scattering technologies in evaluating the
formulation stability of two of Novozymes leading recombinant albumin
products - Albucult® and Recombumin® - which are used in the manufacture
of human therapeutics.
The
teams applied the resolving and detection capabilities of size
exclusion chromatography light scattering (SEC-LS) and dynamic light
scattering (DLS) offered by Malvern's Zetasizer Nano system to monitor
the stability of these Novozymes products. These results have now been
published as a series of application notes that are freely available on
the Malvern Instruments website;
www.malvern.com/labeng/industry/protein/novozymes.htm Mark
Perkins, Customer Solution Specialist from Novozymes explained: "When
developing an active pharmaceutical ingredient it is important to design
a formulation that offers long term stability over a range of storage
conditions. Liquid formulations allow easy and economical product
handling during manufacture and convenience for the end user, but some
proteins prove difficult to formulate in this way. Recombumin and
Albucult have been designed to aid in the development of liquid
formulations of unstable APIs, and a detailed understanding and
confirmation of their stability under a variety of conditions is
essential. The Malvern systems have proved highly effective in this
application, allowing us to further demonstrate the stability and purity
of our products and how this may be translated into improving liquid
biopharmaceutical formulations."
Malcolm
Connah, Product Marketing Manager, Malvern Instruments said: "Malvern
is delighted to be working with a company so active in this important
area of biopharmaceutical development. We look forward to seeing
Recombumin and Albucult helping in the delivery of drugs and vaccines
that are challenging to formulate."
Novozymes'
animal-free, recombinant albumin (rAlbumin) range helps pharmaceutical
drug and medical device manufacturers deliver safe and affordable
product improvements in a variety of applications. Further information
can be found at:
www.biopharma.novozymes.com Dynamic
Light Scattering using the Zetasizer Nano can be applied to predict the
stability of a protein formulation, as well as monitoring how the
protein responds to thermal stress. This information is useful in the
design of production processes and sample handling recommendations.
Further information can be found at:
www.malvern.com/zetasizer Malvern Instruments, Zetasizer and Malvern hills logo are registered trademarks of Malvern Instruments
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